We would like to express our gratitude to Vera and Joseph Eden for their generous contribution to our research, in particular support the research work of Dr. Sara K.

Ethical approval for the trial was obtained from the ethics committee of Hadassah Medical Center, Ein Kerem, Jerusalem (0306-17-HMO, MOH 2017-10-31_00073 4).
1. Study design
<ol>
	<li>Set the target for recruitment at 60 participants and divide the participants into two groups for a 3 month program. 
	NOTE: Power analysis to demonstrate a difference of 2,000 steps/day in intervention vs. nonintervention patients, with a standard deviation of 2,500 steps/day, at 80% power and .05 probability, requires 50 participants. In order to accommodate potential dropouts, five more participants will be recruited in each group.</li>
	<li>Ensure that the participants are adults above the age of 21, with a diagnosis of ischemic heart disease (acute coronary syndrome with or without revascularization). Note that eligible candidates must be clinically stable ambulatory patients who are able to perform physical exercises.</li>
	<li>Exclude the participants with any serious or terminal illness that would preclude CR eligibilityNew York Heart Association Functional Classification (NYHA) above 2 as determined by the assessing cardiologist at the time of the intake. Also exclude patients planning to leave the geographic locale or those who participate in another randomized controlled trials (RCT), and patients who are incapable of using the technology prescribed or do not have a Bluetooth/standardapplication programming interface (API, Apple, Android).</li>
	<li>Perform baseline assessment after informed consent and prior to the start of CR.</li>
	<li>Randomly assign the participants by lottery (sealed envelope method) to the different interventions, namely facility CR or home CR (HCR).</li>
	<li>Derive study variables from measurements and questionnaires obtained pre- and post-intervention. Assess measurements at four time points (baseline, 3 months, 6 months, 12 months) and compare the variables between intervention and control groups. Calculate between-group comparisons for continuous variables using an unpaired t-test or Wilcoxon rank sum test, while categorical variables can be compared using a chi-squared test or Fisher&#39;s exact test for small numbers.</li>
	<li>Conduct within-group comparisons of variables at the four time points using a paired t-test for continuous variables and McNemar&#39;s test for categorical variables. Perform all statistical analysis using SPSS.</li>
</ol>
2. Preparation and end of the study
<ol>
	<li>Do clinical tests and anthropometric measurements. Measure the height, weight, waist circumference, visceral fat and BMI, blood pressure, and HbA1c and lipid profile of the patient.</li>
	<li>Complete a sociodemographic survey (SF-36).</li>
	<li>Perform a graded exercise ECG stress test using the Bruce protocol.</li>
	<li>Design individualized exercise programs.</li>
	<li>Assess the exercise intensity per patient with the heart rate reserve method.</li>
	<li>Complete a survey regarding the benefits and usability of the smart digital garment at the end of the study.</li>
</ol>
3. Patients entering outpatient CR
<ol>
	<li>Facility-based participants
	<ol>
		<li>Let the facility-based participants attend the facility twice/week for 1 h over a 3 month period.</li>
		<li>Ask the participants to exercise at home, as per the guidelines, for at least 150 min of exercise per week at 60% of their target heart rate, with a preference for daily exercise.</li>
	</ol>
	</li>
	<li>HCR participants
	<ol>
		<li>For the first 6 weeks, let HCR participants attend the facility twice/week for 1 h, wearing the wristband (at all times) and the smart digital garment (at predetermined times).</li>
		<li>Tell the participants that they should perform monitored exercise at their individual capacity for 5 days a week, following instructions found in the app.</li>
		<li>Provide support and assistance regarding interventions and the achievement of goals.</li>
		<li>For the next 6 weeks, ask the participants to perform monitored exercise following instructions found in the app and ensure that they exercise at their individual capacity for 5 days a week.</li>
	</ol>
	</li>
</ol>
4. Exercise procedure
<ol>
	<li>Facility-based training protocol
	<ol>
		<li>Combine resistance and aerobic exercises in each training session.</li>
		<li>Measure the patient&#39;s blood pressure 3x, namely before, during, and at the end of each exercise session.</li>
		<li>Have the participant warm up for 5 min.</li>
		<li>Aerobic exercises for 30 min.
		<ol>
			<li>Have the participant bike for 10 min.</li>
			<li>Have the participant walk on the treadmill for 15 min.</li>
			<li>Have the participant paddle on a hand cycle for 5 min.</li>
		</ol>
		</li>
		<li>Have the participant perform resistance training at seven interval stations with active rest: rowing, chest press, leg press, shoulder press, leg extension, lateral pull down, and leg flexion. Each exercise consists of one set of 15 repetitions.</li>
		<li>Have the participant gradually cool down for 5 min.</li>
		<li>Monitor the heart rate using ECG telemetry.</li>
		<li>Make the training progressively more intense by increasing it from light (30% of 1-repetition maximum [1RM]) to 50% of 1RM.</li>
	</ol>
	</li>
	<li>Home-based training protocol
	<ol>
		<li>Let the participant attend the CR facility biweekly for the first 6 weeks and encourage them to perform monitored exercises 5 days a week at home.</li>
		<li>Provide the wearable wristband and the smart digital garment to the participant. While the participant is at the facility, have face-to-face sessions for the introduction of the equipment and instructions on how to use it.</li>
		<li>Ask the participant to wear the wristband at all time and the smart digital garment at predetermined times.</li>
		<li>Transfer ECG measurements before, during, and after the patient walks on the treadmill.</li>
		<li>Have the participant work out at home according to the instructions given in the app or digitally via chat or face to face by the coordinator. Provide support and assistance regarding interventions and the achievement of goals.</li>
		<li>For the remaining 6 weeks, let the participant exercise only at home.</li>
		<li>Tell the participant to wear the smart garment twice a week, and transfer ECG measurements before, during, and after performing proactive walking.</li>
		<li>Have the participant send manual blood pressure measurements via the app, taken before and after performing proactive walking.</li>
		<li>Confirm that the participant has taken his medications daily.</li>
	</ol>
	</li>
</ol>

The authors have nothing to disclose.

Home-based digital monitoring allows health care providers to acquire the patient&#39;s physiological data and have a follow-up of the patient&#39;s physical activity, as well as the patient&#39;s engagement and behavioral adaptation to a new, healthier regime. The software makes it possible to receive data in a continuous manner, allowing the interpretation of the data by the clinical team while collaborating with the patient, thereby increasing the patient&#39;s engagement regarding their rehabilitation process and their awareness regarding their physical condition. The methodology can detect the contacts and cooperation between coordinator, team, and patient and can postulate the degree of compliance (Figure 7). It can also summarize the patient&#39;s activity during the rehabilitation period (in months) and their time of preference to perform the assignments (Figure 7).
Regularly performing physical activity is a well-established method for preventing and treating cardiovascular diseases1,6. CR is an important tool to promote healthfulness and enhance therapeutic efficacy7,8.
Consensus statements among all agencies American Heart Association (AHA), American Association of Cardiovascular Pulmonary Rehabilitation (AACVPR), Agency for Health Care Policy and Research (AHCPR), American College of Cardiology (ACC), state that cardiac rehabilitation programs should offer a multidisciplinary approach to risk reduction and that programs that consist of exercise training alone are not enough25,26. Currently, CR programs address not only exercise but education (lifestyle) counseling as well27,28. Despite interventions such as utilizing electronic medical records, only a minority of eligible patients are willing to participate in the existing programs13. Moreover, patients&#39; adherence to CR programs is not satisfactory. Home-based models have been developed to overcome obstacles such as distance as well as time constraints29,30,31,32,33,34,35.
Tele-CR has been shown to be as effective as conventional facility-based CR31,36.A meta-analysis comparing home-based to facility-based CR, examining exercise capacity, modifiable risk factors (blood pressure, blood lipid concentrations, and smoking), QoL, and cardiac events showed no differences in outcomes for those receiving home-based as opposed to facility-based rehabilitation in either the short term (&#60;12 months) or long term (&#62;12 months)37. Moreover, remote monitoring has an added value by allowing more patients to participate in rehabilitation programs and, specifically designed for those patients who cannot enroll in the facility-based CR, it can be used as an alternative for low-to-moderate cardiac risk patients36. A cost-benefit analysis comparing the two regimes found a benefit for either combined facility-home monitoring CR or telerehabilitation alone36,38.
Currently, home-based physical activity programs utilize diaries/questionnaires and mobile phone-based interventions29,30,31,32,35,39. However, all current remote home-based monitoring devices lack the technology to share data with the clinical team in real-time. Moreover, the clinical team&#39;s evaluation depends on the patient&#39;s subjective reports, which may not accurately reflect their condition. Another disadvantage is the lack of a daily team and group interaction and support. Furthermore, physical activity diaries should be interpreted cautiously unless the participants have an adequate understanding of physical activity intensity40.
Unlike with other telemedicine programs, which depend on the coordination of telephone calls and subjective reporting, clinical data using the current system can also be obtained retrospectively. The coordinator and team can communicate with patients via daily chat or calls, according to the mutual time convenience of patients and staff. Therefore, it is expected to find an improved collaboration between the patient and the multidisciplinary team. The AI system allows for the monitoring and identification of abnormal results that require the attention of the staff, such as an increase in blood pressure indices, changes in heart rate, failure to reach daily goals, etc. The assemblage of physiological information, including the parameters actively transmitted by the patient, such as blood pressure and ECG transmission, enables the rehabilitative team to treat the patient&#39;s complaints, to relieve anxieties, and to address symptoms such as a sense of palpitations, weakness, and fatigue. The patient learns to adopt new habits with the help of behavioral tools, daily feedback, and motivational elements, increasing the level of satisfaction and motivation to cooperate.
The methodology represented here, via the graph analysis, reflects the patient&#39;s new adapted lifestyle and provides scientists with information about the patient&#39;s engagement and interaction with the program, which cannot be done with standard questionnaires. However, this method has its limitations. First, the ECG platform is not connected or synchronized with the digital platform. For now, there is no interface between the two systems, requiring patients and staff to switch between apps. Second, technology usability barriers, difficulties using smartphone apps, and the fact that there is data that patients need to enter on their own make the methodology not suitable for all patients. It all depends on the capabilities and skills of the patients in using digital appliances and also on their ability to deal with the content and digital control.
Currently, the study is underway. The main goal is to encourage long-term health promotion and adherence with the aim to be economically cost efficient as well. In terms of technological capabilities, the goal is to make the digital system accessible to the entire population so that every patient could use the system without restrictions.

Regular exercise is an important method to prevent and treat cardiovascular disease1,2,3,4,5,6. Exercise lowers the risk of progression of vascular disease and significantly lowers the risk of cardiovascular morbidity and mortality7,8,9,10. Physical activity (PA) also improves endothelial dysfunction and restores arterial plasticity6,11. For patients discharged from the hospital with a diagnosis of coronary heart disease, CR programs are an important tool to promote health1,9. However, despite the evidence that CR reduces the risk of recurrent events following acute coronary syndromes, only a minority of eligible patients are willing to join existing programs at cardiac rehabilitation centers12,13. The reasons for this are many-lack of time and lack of motivation, a long distance between home and the CR center, and inconvenient accessibility. Whatever the reason, these patients are at a higher risk of recurrent events and hospitalizations, leading to reduced survival chances and quality of life with high costs. In order to prevent this, it is essential to find an alternative program for patients who cannot participate in a traditional rehabilitation program. Recent advances in mobile technology enable novel approaches to remotely guide and support these patients on an ongoing basis at relatively low cost14,15,16,17,18,19. The hypothesis of the study is that the novel approach of using remote patient-monitoring devices will enable a more convenient method of increasing participation in CR while achieving results similar to those of traditional cardiac rehabilitation.
The study has two arms, namely (1) home-based monitored exercise using the smart digital garment and wristband,in addition to motivation and reinforcement via text messages; (2) standard CR facility-based exercise with standard instructions regarding home-based exercise, not using a garment or wristband.
The health technology on trial combines mobile technology, artificial intelligence, and supportive services to expand the delivery of medical care from cardiac rehabilitation to the patient&#39;s home, empowering patients to better manage their health. A complete digital framework in three layers was designed for CR needs, including a personal (patient) layer, a support (coach) layer, and an information (education and guidance, administrative) layer (Figure 1). The program registers clinicians, coaches, and patients immediately. It is tailored to address a range of needs, including physical activity, behavioral health, medication, and nutrition, via chat, video, and audio communication channels between patients and coaches. Patients wearing a special wristband and smart digital garment (see the Table of Materials) will have 24/7 reciprocal multichannel access to their coach via their mobile phone for a personal plan and video and audio guidance. The coach is able to track the patient&#39;s activity at all times, leading to more precisely followed care plans and healthier decisions (Figure 2 and Figure 3). Commercially available, wearable PE tracking technology, which can connect users&#39; PA data to an online network (control center), has the potential to partially address the need for innovative methods20,21. A wearable advanced fitness tracker (see the Table of Materials) will track the patient&#39;s heart rate and measure footsteps taken, distance traveled, floors climbed, active minutes, exercise, calories burned, and also sleep quality. The bracelet in the study (see the Table of Materials) was chosen as it is commonly used in various studies22,23. Also, for a population with reduced functional capacity, it is better and more suitable as it is more sensitive to movement24. As for the sample frequency, the pulse samples are taken continuously during activity and every minute during the day. In addition, the smart digital garment will be worn at predetermined times to allow tracking of various cardiac electrical changes as recorded by the patient&#39;s ECG (Figure 4).
The system is built with three integrated components, namely the smart digital garment, which is a machine-washable platform 12-lead ECG garment, a continuous remote monitoring and recording ECG device, and a cloud artificial intelligence (AI) server, which is cloud/server-based software for patient management and vital signs event detection (see the Table of Materials). The wearable fabric electrodes are robust in withstanding interference so that they can be used with minimal impact during normal daily activities, including walking, jogging, sitting, driving, sleeping, and exercising. The anatomical locations of the electrodes in the garment are the same as for electrodes during a standard ECG measurement. The standard limb leads I, II, and III each record the differences in electrical potential between two limbs. An additional six unipolar leads record the electrical potential difference between an exploring electrode and an electrode located centrally on the chest and computed from the average of the limb recordings (Figure 4). The connector in the garment is an High-Definition Multimedia Interface (HDMI) connector that is connected to the ECG device or to other standard ECG devices using an external adaptor. The device is a miniature ECG with an embedded processor containing data acquisition, data storage, data processing, accelerometer, respiration, body temperature (IR), and Bluetooth (BT) capabilities. The device acts as an ECG loop recorder, containing patient trigger event transmitting, live ECG transmission upon demand by the physician for a defined time period, and future auto-event detection of cardiac arrhythmia and ischemia. The heart rate accuracy of the smart garment is between 10-300 &#177; 2 bpm, and the frequency of the ECG device is 250 Hz. The device transmits the data in real-time to a communication device (such as a smartphone or tablet computer) with the dedicated mobile application via BT communication, so that the application can forward the data to a server for professional review via wireless internet access (see the Table of Materials). The platform data is stored in accordance with the Health Insurance Probability and Accountability Act (HIPAA) Privacy Rule for healthcare providers. The patient&#39;s ECG data is transferred to the cloud and encrypted and cyber-secured according to HIPPA regulations.
The participant&#39;s maximal heart rate is determined during a baseline exercise test. Aerobic exercises are performed continually at 60%-70% of the participant&#39;s heart rate reserve, using the modified Borg scale to evaluate perceived exertion during and after each training session. Treadmill speed and incline or cycle resistance and cadence are adjusted as needed to ensure that the assigned heart rate is reached at each training session. Evaluation of the degree of the patient&#39;s adherence and persistence and of the extent of the patient&#39;s involvement is done according to the intensity of use of chat and the manual delivery of data such as blood pressure.

<table><tbody><tr><td>FitBit Charge 2</td><td>FitBit</td><td>Model Name: FB407</td><td></td></tr><tr><td>Master Caution Garment</td><td>HealthWatch</td><td>MCG-M-XL</td><td></td></tr><tr><td>Master Caution Device</td><td>HealthWatch</td><td>MCD</td><td></td></tr><tr><td>Spectra 360 electrode gel</td><td>Parker labs</td><td>12-08</td><td></td></tr></tbody></table>

a novel digital platform for a monitored home-based cardiac rehabilitation program

Despite the evidence that cardiac rehabilitation (CR) reduces the risk of recurrent cardiac events, only a minority of eligible patients are willing to join existing programs at cardiac rehabilitation centers. The unique remote patient monitoring system presented here enables healthcare providers to monitor CR patients at home in real-time and at low cost. The system combines mobile technology, artificial intelligence, and supportive services, expanding the delivery of medical care to the patient&#39;s home. The primary aim of the study is to increase the long-term adherence to physical activity in patients who participate in CR via the addition of a home-based digitally monitored CR component to the standard CR program in patients with ischemic heart disease (IHD), with the idea of forming new habitual health behaviors and increasing the long-term motivation for physical exercise (PE) habits at home. Secondary aims are to assess the program&#39;s impact on the physical activity level measured by average steps per day, minutes of exercise per week, blood pressure, metabolic parameters, body mass index, and waist-to-hip ratio, as well as a quality-of-life (QoL) questionnaire.The study has two arms: (1) home-based monitored exercise using a smart digital garment and wristband, in addition to motivation and reinforcement via text messages; (2) standard CR facility-based exercise. The study design is a randomized, controlled trial comparing standard CR to a home-based monitoring and reinforcement program. The study program is designed for 12 weeks.Clinical tests and anthropometric measurements are performed before and after the study, measuring height, weight, waist circumference, visceral fat and body mass index (BMI), blood pressure, and HbA1c and lipid profile. Patients have to complete a baseline survey including socio-demographic characteristics and QoL questionnaire SF-36. At the end of the study, patients complete a survey regarding the use of the smart digital garment&#39;s benefits and usability. The study is currently underway.

At present, 20 participants have been recruited to the study. For the participants in the study group, the smart digital garment and wristband are used as monitored tracking devices for most of the variables measured. Some variables, such as food intake, sugar levels, and weight, are entered manually by the patient. The patients in the study group have to wear the wristband most of the day and the smart digital garment twice a week for 30 min for 6 weeks while they are in the CR facility and 6 more weeks at home.
To perform the study, the wristband is used to measure all the physiological variables needed, and the smart digital garment is used for performing ECG. Both devices transmit the measured data to a smartphone that operates an application designed to collect data and transmit it directly to the system. The system is programmed to analyze and then execute the material analyzed (Figure 1). A dashboard facilitates the collection and visualization of the raw and analyzed data (Figure 2).
A combination of commercially available wearable tools is used with a system capable of evaluating and quantifying the various variables designed especially for the assessment of heart patients who use these devices. To this end, changes in physiological signals such as heart rate, sugar, and sleep, as well as nutrition data and more, are measured. In the course of the various activities, it is possible to assess the activity or inactivity of the patient on a daily basis, to know the patient&#39;s condition in real-time. After analyzing the data by the system, an immediate evaluation can be done by the medical team at the center who observes the results that appear on the dashboard (Figure 2 and Figure 3). The team has the ability to react immediately to any deviation from normal. The patient is under observation all day, and the coordinator is in contact with the patient to encourage them to continue keeping up their activity levels or to check why there is no activity by sending the patient daily to monthly graphic reports, and this is done throughout the 3 months&#39; program (Figure 5 and Figure 6).
At this stage, initial observations, comments, and responses from participants show a clear preference for home digital telemedicine. Everyday contact via chat and the ability to practice throughout the day rather than being on a rigid schedule gives them an incentive to practice and be rehabilitated. Patients report a decrease in anxiety, and they are more confident and relaxed and sleep better at night for more time. The various indices measured also indicate an improvement; a decrease in general and abdominal fat levels and increased muscle mass was also observed, but this cannot yet be assessed statistically.
The results obtained from this study should support an alternative, home-based approach to enhance the long-term therapeutic efficacy of cardiac rehabilitation, especially for those patients who are unwilling or unable to participate in traditional rehabilitation programs.
<img alt="Figure 1" class="xfigimg" src="/files/ftp_upload/59019/59019fig1.jpg" /> 
Figure 1: The digital program concept. The program registers the clinicians, as well as coaches and onboard patients, immediately. It is tailored to address the range of the medical team&#39;s needs concerning physical activity, behavioral health, medication, and nutrition via the application video and audio communication channels between patients and coaches.
<img alt="Figure 2" class="xfigimg" src="/files/ftp_upload/59019/59019fig2.jpg" /> 
Figure 2: The platform dashboard. Patients, wearing a special wristband and garment, will have reciprocal multichannel access to their coach via their mobile phone for a personal plan and video and audio guidance. The coach is able to track the patient&#39;s activity at all times, leading to more precisely followed care plans and healthier decisions. <a href="https://www.jove.com/files/ftp_upload/59019/59019fig2large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<img alt="Figure 3" class="xfigimg" src="/files/ftp_upload/59019/59019fig3.jpg" /> 
Figure 3: One patient&#39;s program. The patient is in observation all day long. The coordinator/coach is able to track the patient&#39;s activity at all times and is in contact with the patient to encourage them to continue their activity or to check why there is no activity. The multidisciplinary team has the ability to react immediately to any deviation from normality. <a href="https://www.jove.com/files/ftp_upload/59019/59019fig3large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<img alt="Figure 4" class="xfigimg" src="/files/ftp_upload/59019/59019fig4.jpg" /> 
Figure 4: The Master Caution garment and the electrodes&#39; locations. The standard limb leads I, II, and III each record the differences in electrical potential between two limbs. An additional six unipolar leads record the electrical potential difference between an exploring electrode and an indifferent electrode located centrally in the chest and computed from the average of the limb recordings. <a href="https://www.jove.com/files/ftp_upload/59019/59019fig4large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<img alt="Figure 5" class="xfigimg" src="/files/ftp_upload/59019/59019fig5.jpg" /> 
Figure 5: Graph reports for one patient. (A) A day of an active person. (B) A day of a sedentary person. (C) Average resting heart rate. Patients can be followed per day and per month. Heart rate = heart rate per minute. <a href="https://www.jove.com/files/ftp_upload/59019/59019fig5large.jpg" target="_blank">Please click here to view a larger version of this figure.</a>
<img alt="Figure 6" class="xfigimg" src="/files/ftp_upload/59019/59019fig6.jpg" /> 
Figure 6: Graph reports for one patient. (A) Blood pressure. (B) Steps chart. Patients can be followed per day and per month.&#160;
<img alt="Figure 7" class="xfigimg" src="/files/ftp_upload/59019/59019fig7.jpg" /> 
Figure 7:&#160;Daily behavior of one patient as aggregate activity during 6 months. Patient&#39;s engagement and frequency points of contact, through the app, between him and his coordinator. The green color shows the extent and time of communication between the coordinator and the patient displayed as touchpoints. The blue color indicates the number of measurements of the various indices as sent by the patient throughout one day, displayed as touchpoints.

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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program

The aim is to promote a new approach to cardiac rehabilitation (CR), using a unique remote patient monitoring system that will enable healthcare providers to monitor CR patients at home at low cost, with the intention of making CR services more accessible and improving compliance. The study is currently underway.

Despite the evidence that cardiac rehabilitation (CR) reduces the risk of recurrent cardiac events, only a minority of eligible patients are willing to ...

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11.5K Views.  Jerusalem, Israel. The aim is to promote a new approach to cardiac rehabilitation (CR), using a unique remote patient monitoring system that will enable healthcare providers to monitor CR patients at home at low cost, with the intention of making CR services more accessible and improving compliance. The study is currently underway. 

Video: A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program

Mobile Game-based Virtual Reality Program for Upper Extremity Stroke Rehabilitation

Stroke rehabilitation requires repetitive, intensive, goal-oriented therapy. Virtual reality (VR) has the potential to satisfy these requirements. Game-based therapy can promote patients&#39; engagement in rehabilitation therapy as a more interesting and a motivating tool. Mobile devices such as smartphones and tablet PCs can provide personalized home-based therapy with interactive communication between patients and clinicians. In this study, a mobile VR upper extremity rehabilitation program using game applications was developed. The findings from the study show that the mobile game-based VR program effectively promotes upper extremity recovery in patients with stroke. In addition, patients completed two weeks of treatment using the program without adverse effects and were generally satisfied with the program. This mobile game-based VR upper extremity rehabilitation program can substitute for some parts of the conventional therapy that are delivered one-on-one by an occupational therapist. This time-efficient, easy to implement, and clinically effective program would be a good candidate tool for tele-rehabilitation for upper extremity recovery in patients with stroke. Patients and therapists can collaborate remotely through these e-health rehabilitation programs while reducing economic and social costs.

Here, we present a protocol to develop and apply a mobile game-based virtual reality program for the recovery of upper limb dysfunction in patients with stroke. The present study shows that the mobile program is feasible and effectively promotes upper limb recovery in stroke patients.

Stroke rehabilitation requires repetitive, intensive, goal-oriented therapy. Virtual reality (VR) has the potential to satisfy these requirements. ...

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data

An end-to-end suite of technologies has been established for the unobtrusive and continuous monitoring of health and activity changes occurring in the daily life of older adults over extended periods of time. The technology is aggregated into a system that incorporates the principles of being minimally obtrusive, while generating secure, privacy protected, continuous objective data in real-world (home-based) settings for months to years. The system includes passive infrared presence sensors placed throughout the home, door contact sensors installed on exterior doors, connected physiological monitoring devices (such as scales), medication boxes, and wearable actigraphs. Driving sensors are also installed in participants' cars and computer (PC, tablet or smartphone) use is tracked. Data is annotated via frequent online self-report options that provide vital information with regard to the data that is difficult to infer via sensors such as internal states (e.g., pain, mood, loneliness), as well as data referent to activity pattern interpretation (e.g., visitors, rearranged furniture). Algorithms have been developed using the data obtained to identify functional domains key to health or disease activity monitoring, including mobility (e.g., room transitions, steps, gait speed), physiologic function (e.g., weight, body mass index, pulse), sleep behaviors (e.g., sleep time, trips to the bathroom at night), medication adherence (e.g., missed doses), social engagement (e.g., time spent out of home, time couples spend together), and cognitive function (e.g., time on computer, mouse movements, characteristics of online form completion, driving ability). Change detection of these functions provides a sensitive marker for the application in health surveillance of acute illnesses (e.g., viral epidemic) to the early detection of prodromal dementia syndromes. The system is particularly suitable for monitoring the efficacy of clinical interventions in natural history studies of geriatric syndromes and in clinical trials.

Unobtrusive sensors and pervasive computing technology incorporated into the daily home life of older adults enables meaningful health and activity changes to be recorded continuously for months to years, providing ecologically valid, high frequency, multi-domain data for research or clinical use.

An end-to-end suite of technologies has been established for the unobtrusive and continuous monitoring of health and activity changes occurring in the ...

Using Continuous Data Tracking Technology to Study Exercise Adherence in Pulmonary Rehabilitation

Pulmonary rehabilitation (PR) is an important component in the management of respiratory diseases. The effectiveness of PR is dependent upon adherence to exercise training recommendations. The study of exercise adherence is thus a key step towards the optimization of PR programs. To date, mostly indirect measures, such as rates of participation, completion, and attendance, have been used to determine adherence to PR. The purpose of the present protocol is to describe how continuous data tracking technology can be used to measure adherence to a prescribed aerobic training intensity on a second-by-second basis.
In our investigations, adherence has been defined as the percent time spent within a specified target heart rate range. As such, using a combination of hardware and software, heart rate is measured, tracked, and recorded during cycling second-by-second for each participant, for each exercise session. Using statistical software, the data is subsequently extracted and analyzed. The same protocol can be applied to determine adherence to other measures of exercise intensity, such as time spent at a specified wattage, level, or speed on the cycle ergometer. Furthermore, the hardware and software is also available to measure adherence to other modes of training, such as the treadmill, elliptical, stepper, and arm ergometer. The present protocol, therefore, has a vast applicability to directly measure adherence to aerobic exercise.

Pulmonary rehabilitation is widely recognized in the management of respiratory diseases. A key component to successful pulmonary rehabilitation is adherence to the recommended exercise training. The purpose of the present protocol is to describe how continuous data tracking technology can be used to precisely measure adherence to a prescribed aerobic training intensity.

Pulmonary rehabilitation (PR) is an important component in the management of respiratory diseases. The effectiveness of PR is dependent upon adherence to ...

Medicine

Walk with Me Hybrid Virtual/In-Person Walking for Older Adults with Neurodegenerative Disease

This study presents a protocol for virtual and in-person walking groups for older adults with neurodegenerative diseases and addresses the decline in physical activity and social connectivity during the pandemic. Physical activity, specifically moderate-intensity walking, has been shown to have multiple health benefits for older adults. This methodology was created during the COVID-19 pandemic, contributing to lower physical activity levels and social isolation in older adults. Both the in-person and virtual classes utilize technology such as fitness tracking apps and video platforms. Data are presented from two groups of older adults with neurodegenerative disease: people with prodromal Alzheimer's disease and people with Parkinson's disease. Participants in the virtual classes were screened for balance impairments before the walk, and any person deemed at risk for falls was not eligible to participate virtually. As COVID vaccines became available and restrictions were lifted, in-person walking groups became feasible. Staff and caregivers were trained in balance management, roles/responsibilities, and delivering walking cues. Both walks, virtual and in-person, consisted of a warm up, a walk, and a cool down, and posture, gait, and safety cues were given throughout. Measures of the rate of perceived exertion (RPE) and heart rate (HR) were taken pre-warm up, post-warm up, and at 15 min, 30 min, and 45 min time points. Participants also used a walking application (app) on their phones to record the distance walked and the number of steps taken. The study showed a positive correlation between HR and RPE in both groups. The participants in the virtual group rated the walking group favorably in terms of improving their quality of life during a period of social isolation and contributing to physical, mental, and emotional well-being. The methodology shows a safe and feasible way to implement virtual and in-person walking groups for older adults with neurological diseases.

The present protocol aims to inform rehabilitation specialists and fitness instructors in safe, feasible, and evidence-based methods of delivering virtual and in-person walking classes to older adults with neurodegenerative diseases.

This study presents a protocol for virtual and in-person walking groups for older adults with neurodegenerative diseases and addresses the decline in ...

The Immersive Cleveland Clinic Virtual Reality Shopping Platform for the Assessment of Instrumental Activities of Daily Living

A decline in the performance of instrumental activities of daily living (IADLs) has been proposed as a prodromal marker of neurological disease. Existing clinical and performance-based IADL assessments are not feasible for integration into clinical medicine. Virtual reality (VR) is a powerful yet underutilized tool that could advance the diagnosis and treatment of neurological disease. An impediment to the adoption and scaling of VR in clinical neurology is VR-related sickness resulting from sensory inconsistencies between the visual and vestibular systems (i.e., locomotion problem).
The Cleveland Clinic Virtual Reality Shopping (CC-VRS) platform attempts to solve the locomotion problem by coupling an omnidirectional treadmill with high-resolution VR content, enabling the user to physically navigate a virtual grocery store to simulate shopping. The CC-VRS consists of Basic and Complex shopping experiences; both require walking 150 m and retrieving five items. The Complex experience has additional scenarios that increase the cognitive and motor demands of the task to better represent the continuum of activities associated with real-world shopping. The CC-VRS platform provides objective and quantitative biomechanical and cognitive outcomes related to the user&#39;s IADL performance. Initial data indicate that the CC-VRS results in minimal VR-sickness and is feasible and tolerable for older adults and patients with Parkinson&#39;s disease (PD). The considerations underlying the development, design, and hardware and software technology are reviewed, and initial models of integration into primary care and neurology are provided.

Virtual reality (VR) is a powerful yet underutilized approach to advance the diagnosis and treatment of neurological disease. The Cleveland Clinic Virtual Reality Shopping platform combines state-of-the-art VR content with an omnidirectional treadmill to quantify instrumental activities of daily living-a proposed prodromal marker of neurological disease.

A decline in the performance of instrumental activities of daily living (IADLs) has been proposed as a prodromal marker of neurological disease. Existing ...

Engineering

Integrating VR and Biosensors for Quantitative Motion-Muscle Activity Assessment

Setup for the Quantitative Assessment of Motion and Muscle Activity During a Virtual Modified Box and Block Test

The ability to move allows us to interact with the world. When this ability is impaired, it can significantly reduce one's quality of life and independence and may lead to complications. The importance of remote patient evaluation and rehabilitation has recently grown due to limited access to in-person services. For example, the COVID-19 pandemic unexpectedly resulted in strict regulations, reducing access to non-emergent healthcare services. Additionally, remote care offers an opportunity to address healthcare disparities in rural, underserved, and low-income areas where access to services remains limited. 
Improving accessibility through remote care options would limit the number of hospital or specialist visits and render routine care more affordable. Finally, the use of readily available commercial consumer electronics for at-home care can enhance patient outcomes due to improved quantitative observation of symptoms, treatment efficacy, and therapy dosage. While remote care is a promising means to address these issues, there is a crucial need to quantitatively characterize motor impairment for such applications. The following protocol seeks to address this knowledge gap to enable clinicians and researchers to obtain high-resolution data on complex movement and underlying muscle activity. The ultimate goal is to develop a protocol for remote administration of functional clinical tests. 
Here, participants were instructed to perform a medically-inspired Box and Block task (BBT), which is frequently used to assess hand function. This task requires subjects to transport standardized cubes between two compartments separated by a barrier. We implemented a modified BBT in virtual reality to demonstrate the potential of developing remote assessment protocols. Muscle activation was captured for each subject using surface electromyography. This protocol allowed for the acquisition of high-quality data to better characterize movement impairment in a detailed and quantitative manner. Ultimately, these data have the potential to be used to develop protocols for virtual rehabilitation and remote patient monitoring.

Author Spotlight: Enhancing Remote Rehabilitation with Virtual Reality and Electromyography

The protocol described here aims to enhance the quantitative evaluation of upper limb deficits, with the goal of developing additional technology for remote assessment both in the clinic and at home. Virtual reality and biosensor technologies are combined with standard clinical techniques to provide insights into the functioning of the neuromuscular system.

The ability to move allows us to interact with the world. When this ability is impaired, it can significantly reduce one's quality of life and ...

Home-Based Monitor for Gait and Activity Analysis

Current outcomes in neuromuscular disorder clinical trials include motor function scales, timed tests, and strength measures performed by trained clinical evaluators. These measures are slightly subjective and are performed during a visit to a clinic or hospital and constitute therefore a point assessment. Point assessments can be influenced by daily patient condition or factors such as fatigue, motivation, and intercurrent illness. To enable home-based monitoring of gait and activity, a wearable magneto-inertial sensor (WMIS) has been developed. This device is a movement monitor composed of two very light watch-like sensors and a docking station. Each sensor contains a tri-axial accelerometer, gyroscope, magnetometer, and a barometer that record linear acceleration, angular velocity, the magnetic field of the movement in all directions, and barometric altitude, respectively. The sensors can be worn on the wrist, ankle, or wheelchair to record the subject&#8217;s movements during the day. The docking station enables data uploading and recharging of sensor batteries during the night. Data are analyzed using proprietary algorithms to compute parameters representative of the type and intensity of the performed movement. This WMIS can record a set of digital biomarkers, including cumulative variables, such as total number of meters walked, and descriptive gait variables, such as the percentage of the most rapid or longest stride that represents the top performance of patient over a predefined period of time.

This innovative device uses magneto-inertial sensors to permit gait and activity analysis in uncontrolled environments. Currently in the qualification process as an outcome measure in the European Medical Agency, one of the applications will be to serve as a clinical endpoint in clinical trials in neuromuscular diseases.

Current outcomes in neuromuscular disorder clinical trials include motor function scales, timed tests, and strength measures performed by trained clinical ...

Bioengineering

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

The MACCS (Medical Assistant for Chronic Care Service) platform enables secure sharing of key medical information between patients after kidney transplantation and physicians. Patients provide information such as vital signs, well-being, and medication intake via smartphone apps. The information is transferred directly into a database and electronic health record at the kidney transplant center, which is used for routine patient care and research. Physicians can send an updated medication plan and laboratory data directly to the patient app via this secure platform. Other features of the app are medical messages and video consultations. Consequently, the patient is better-informed, and self-management is facilitated. In addition, the transplant center and the patient's local nephrologist automatically exchange notes, medical reports, laboratory values, and medication data via the platform. A telemedicine team reviews all incoming data on a dashboard and takes action, if necessary. Tools to identify patients at risk for complications are under development. The platform exchanges data via a standardized secure interface (Health Level 7 (HL7), Fast Healthcare Interoperability Resources (FHIR)). The standardized data exchange based on HL7 FHIR guarantees interoperability with other eHealth solutions and allows rapid scalability to other chronic diseases. The underlying data protection concept is in concordance with the latest European General Data Protection Regulation. Enrollment started in February 2020, and 131 kidney transplant recipients are actively participating as of July 2020. Two large German health insurance companies are currently funding the telemedicine services of the project. The deployment for other chronic kidney diseases and solid organ transplant recipients is planned. In conclusion, the platform is designed to enable home monitoring and automatic data exchange, empower patients, reduce hospitalizations, and improve adherence, and outcomes after kidney transplantation.

The MACCS platform&#160;is a comprehensive telemedicine concept aiming at better outcomes after kidney transplantation by sharing key medical information between patients and physicians. A telemedicine team reviews incoming data to detect potential complications and to improve adherence in kidney transplant recipients to achieve better long-term outcomes.

The MACCS (Medical Assistant for Chronic Care Service) platform enables secure sharing of key medical information between patients after kidney ...

Optimizing Deep Brain Stimulation for Patients with Neurological Disorders

Bringing the Clinic Home: An At-Home Multi-Modal Data Collection Ecosystem to Support Adaptive Deep Brain Stimulation

Adaptive deep brain stimulation (aDBS) shows promise for improving treatment for neurological disorders such as Parkinson's disease (PD). aDBS uses symptom-related biomarkers to adjust stimulation parameters in real-time to target symptoms more precisely. To enable these dynamic adjustments, parameters for an aDBS algorithm must be determined for each individual patient. This requires time-consuming manual tuning by clinical researchers, making it difficult to find an optimal configuration for a single patient or to scale to many patients. Furthermore, the long-term effectiveness of aDBS algorithms configured in-clinic while the patient is at home remains an open question. To implement this therapy at large scale, a methodology to automatically configure aDBS algorithm parameters while remotely monitoring therapy outcomes is needed. In this paper, we share a design for an at-home data collection platform to help the field address both issues. The platform is composed of an integrated hardware and software ecosystem that is open-source and allows for at-home collection of neural, inertial, and multi-camera video data. To ensure privacy for patient-identifiable data, the platform encrypts and transfers data through a virtual private network. The methods include time-aligning data streams and extracting pose estimates from video recordings. To demonstrate the use of this system, we deployed this platform to the home of an individual with PD and collected data during self-guided clinical tasks and periods of free behavior over the course of 1.5 years. Data were recorded at sub-therapeutic, therapeutic, and supra-therapeutic stimulation amplitudes to evaluate motor symptom severity under different therapeutic conditions. These time-aligned data show the platform is capable of synchronized at-home multi-modal data collection for therapeutic evaluation. This system architecture may be used to support automated aDBS research, to collect new datasets and to study the long-term effects of DBS therapy outside the clinic for those suffering from neurological disorders.

Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring 

The protocol shows a prototype of the at-home multi-modal data collection platform that supports research optimizing adaptive deep brain stimulation (aDBS) for people with neurological movement disorders. We also present key findings from deploying the platform for over a year to the home of an individual with Parkinson's disease.

Adaptive deep brain stimulation (aDBS) shows promise for improving treatment for neurological disorders such as Parkinson's disease (PD). aDBS uses ...

Neuroscience

Enhancing Stroke Rehabilitation with Virtual Reality-Based Occupational Training

Cognitive Function and Upper Limb Rehabilitation Training Post-Stroke Using a Digital Occupational Training System

Stroke rehabilitation often requires frequent and intensive therapy to improve functional recovery. Virtual reality (VR) technology has shown the potential to meet these demands by providing engaging and motivating therapy options. The digital occupational training system is a VR application that utilizes cutting-edge technologies, including multi-touch screens, virtual reality, and human-computer interaction, to offer diverse training techniques for advanced cognitive capacity and hand-eye coordination abilities. The objective of this study was to assess the effectiveness of this program in enhancing cognitive function and upper extremity rehabilitation in stroke patients. The training and assessment consist of five cognitive modules covering perception, attention, memory, logical reasoning, and calculation, along with hand-eye coordination training. This research indicates that after eight weeks of training, the digital occupational training system can significantly improve cognitive function, daily living skills, attention, and self-care abilities in stroke patients. This software can be employed as a time-saving and clinically effective rehabilitation aid to complement traditional one-on-one occupational therapy sessions. In summary, the digital occupational training system shows promise and offers potential financial benefits as a tool to support the functional recovery of stroke patients.

Author Spotlight: Rehabilitation of Stroke Patients With a Digital Occupational Training System

The current protocol outlines how the VR-based digital occupational training system enhances the rehabilitation of patients with cognitive impairment and upper limb dysfunction following a stroke.