Name: home-based monitor for gait and activity analysis
Uploaded: 2019-08-08T13:30:00
Description: Watch this Scientific Journal Video about Home-Based Monitor for Gait and Activity Analysis at JoVE.com

The authors thank Anne-Ga&#235;lle Le Moing, Am&#233;lie Moreaux, and Eric Dorveaux for their contribution to the development of this wearable magneto-inertial sensor and Jackie Wyatt for the review.

Any use of the device must be carried out in accordance with the rules established by the reference protocol, validated by the ethics committee and the national regulatory agencies of the country. The use of the device and the various elements attached to it must be done within the intended use described in the patient&#39;s manual.
NOTE: To be eligible to use of the WMIS, patient must be over 5 years old, be able to understand and follow the usage rules, provide informed consent, be affiliate...

<ol>
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M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Ataluren+in+patients+with+nonsense+mutation+Duchenne+muscular+dystrophy+(ACT+DMD):+a+multicentre,+randomised,+double-blind,+placebo-controlled,+phase+3+trial.">Ataluren in patients with nonsense mutation Duchenne muscular dystrophy (ACT DMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.</a> The Lancet. 390 (10101), 1489-1498 (2017).</li><li>Aartsma-Rus, A., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+of+Exon+Skipping+Therapies+for+Duchenne+Muscular+Dystrophy:+A+Critical+Review+and+a+Perspective+on+the+Outstanding+Issues.">Development of Exon Skipping Therapies for Duchenne Muscular Dystrophy: A Critical Review and a Perspective on the Outstanding Issues.</a> Nucleic Acid Therapeutics. 27 (5), 251-259 (2017).</li><li>McDonald, C. 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M., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Upper+Limb+Evaluation+and+One-Year+Follow+Up+of+Non-Ambulant+Patients+with+Spinal+Muscular+Atrophy:+An+Observational+Multicenter+Trial.">Upper Limb Evaluation and One-Year Follow Up of Non-Ambulant Patients with Spinal Muscular Atrophy: An Observational Multicenter Trial.</a> PLoS One. 10 (4), e0121799 (2015).</li><li>Servais, L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Innovative+methods+to+assess+upper+limb+strength+and+function+in+non-ambulant+Duchenne+patients.">Innovative methods to assess upper limb strength and function in non-ambulant Duchenne patients.</a> Neuromuscular Disorders. 23 (2), 139-148 (2013).</li><li>Le Moing, A. 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H. M., Verheyen, C. C. P. M., Zijlstra, W. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+body-fixed-sensor+based+analysis+of+compensatory+trunk+movements+during+unconstrained+walking.">A body-fixed-sensor based analysis of compensatory trunk movements during unconstrained walking.</a> Gait &amp; Posture. 27 (1), 164-167 (2008).</li><li>Brandes, M., Zijlstra, W., Heikens, S., van Lummel, R., Rosenbaum, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Accelerometry+based+assessment+of+gait+parameters+in+children.">Accelerometry based assessment of gait parameters in children.</a> Gait &amp; Posture. 24 (4), 482-486 (2006).</li><li>Liu, K., Liu, T., Shibata, K., Inoue, Y., Zheng, R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Novel+approach+to+ambulatory+assessment+of+human+segmental+orientation+on+a+wearable+sensor+system.">Novel approach to ambulatory assessment of human segmental orientation on a wearable sensor system.</a> Journal of Biomechanics. 42 (16), 2747-2752 (2009).</li><li>Itoh, T., Morioka, I. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Developing+Leg-Motion+Measurement+System+Using+Acceleration+Sensors.">Developing Leg-Motion Measurement System Using Acceleration Sensors.</a> Electrical Engineering in Japan. 204 (1), 59-66 (2018).</li><li>Scott, E., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Development+of+a+functional+assessment+scale+for+ambulatory+boys+with+Duchenne+muscular+dystrophy.">Development of a functional assessment scale for ambulatory boys with Duchenne muscular dystrophy.</a> Physiotherapy Research International. 17 (2), 101-109 (2012).</li><li>Sonenblum, S. E., Sprigle, S., Caspall, J., Lopez, R. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Validation+of+an+accelerometer-based+method+to+measure+the+use+of+manual+wheelchairs.">Validation of an accelerometer-based method to measure the use of manual wheelchairs.</a> Medical Engineering &amp; Physics. 34 (6), 781-786 (2012).</li><li>Hiremath, S. V., Ding, D. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Regression+equations+for+RT3+activity+monitors+to+estimate+energy+expenditure+in+manual+wheelchair+users.">Regression equations for RT3 activity monitors to estimate energy expenditure in manual wheelchair users.</a> 2011 Annual International Conference of the IEEE Engineering in Medicine and Biology Society. , 7348-7351 (2011).</li><li>Ciuti, G., Ricotti, L., Menciassi, A., Dario, P. M. E. M. 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In the past decade, a number of different systems have been developed, such as an activity monitor (Table of Materials [IV]), which uses accelerometric sensors to monitor activities of daily life for energy expenditure quantification13. A triaxial accelerometer (Table of Materials [V]) was used by Tanaka et al.14 to monitor activity of preschool children. Lau et al.15 showed through the combination of a dual-accelero...

A number of potential therapies are in development for treatment of genetic neuromuscular diseases. These diseases include Duchenne muscular dystrophy (DMD) and spinal muscular atrophy (SMA) type 3. Subjects with these diseases present initially with proximal lower limb weakness that leads to progressive difficulties in ambulation. The final step in translational research is the demonstration of efficacy of a potential treatment or approach in a clinical trial. Specific, quantifiable, objective, and reliable measures are required. The importance of such measures was recently emphasized by the failure of the phase IIb ataluren trial1 and the phase III Biomarin trial2. One of the likely explanations for these failures was the variability and the nonlinear evolution of the primary outcome measure of these trials, the 6-minute walk test3 (6 MWT). Increasing reliability and sensitivity to the change of outcome measures and the understanding of the factors leading to their variation could contribute to decrease the number of trial failures related to the main outcome measures.
One of the limitations of the current outcomes is the subjectivity of the assessment. To further increase the objectivity of assessments, Heberer et al.4 showed that through a marker set and the use of a gait analysis software, there was a significant increase in stride length in patients treated with steroids compared with the na&#239;ve group. Hip joint kinetics are early markers of proximal weakness in patients with DMD and are responsive to change with steroid intervention, which is the only available treatment for these patients. Gait laboratories are, however, only available in large clinics. Furthermore, laboratory evaluations are point assessments, and a patient&#8217;s condition may greatly vary on a day to day basis due to factors such as fatigue, motivation, and intercurrent illness.
The use of continuous and home-based measurement should achieve both a more objective and a more globally representative assessment. In other fields of neurology, for instance Parkinson5 or multiple sclerosis6, several studies have assessed the feasibility, reliability, and consistency with other measures of different sensors including accelerometers with or without gyrometers or magnetometers, yet none of these devices is currently a gold standard for evaluation of patients during clinical trials. In the field of neuromuscular diseases, there is currently no validated method for continuous home monitoring of patients. In recent years, through a close collaboration between clinicians and engineers, the Institute of Myology in Paris has developed several devices for upper limb assessment to precisely evaluate upper limb strength and function7,8,9. A wearable magneto-inertial sensor (WMIS; i.e., ActiMyo) has been developed in collaboration with a company specialized in navigation systems. Initially a monitoring device dedicated to non-ambulant subjects with neuromuscular disorders such as DMD and SMA10,11, the same device has now been used to monitor ambulant patients in two different configurations: sensors on both ankles or one sensor at the wrist and the other one at the ankle. The configuration for a non-ambulant population is composed of a sensor at the wheelchair and the other one at the wrist.
This WMIS is able to precisely capture and quantify all movements of the limb on which it is placed. The measuring principle is based on the use of microelectromechanical system (MEMS) inertial sensors and magnetometers operated through magneto-inertial equations. Dedicated algorithms allow precise qualification and quantification of patients&#8217; movements in a non-controlled environment.&#160;
The overall goal of the method is to provide identification and quantification of any movement produced by a patient over a pre-defined period of time, and to integrate these measures into disease-specific outcome measures representative of the patient&#8217;s condition over a period of time.
To effectively assess ambulant and non-ambulant patients with movement disorders at home, the device must be provided to the patient by a trained evaluator who is responsible for making sure that the instructions have been understood. An investigator and a patient manual are provided with the device. This WMIS is currently being used as an exploratory outcome measure in a number of clinical trials for neuromuscular and neurologic diseases (NCT03351270, NCT02780492, NCT01385917, NCT03039686, NCT03368742, NCT02500381). Specific procedures adapted to the pathology and/or to the clinical trial design have been developed.

<table>
	<tbody>
		<tr>
			<td>ActiMyo Sensors</td>
			<td>Sysnav</td>
			<td>SF-000080</td>
			<td>Wearable magneto-inertal sensors attached to the patient for movment recording</td>
		</tr>
		<tr>
			<td>Helen Hayes marker set</td>
			<td>Vicon</td>
			<td>NA</td>
			<td>Whole body jumpsuit with predefined Vicon&#39;s spots</td>
		</tr>
		<tr>
			<td>OrthoTrak (Motion Analysis, Santa Rosa, CA, USA)</td>
			<td>Motion Lab Systems</td>
			<td></td>
			<td>Gait analysis software</td>
		</tr>
		<tr>
			<td>ActiGraph</td>
			<td>ActiGraph Corp</td>
			<td>GTM1</td>
			<td>Activity monitor, used by researchers to capture and record continuous, high resolution physical activity and sleep/wake information</td>
		</tr>
		<tr>
			<td>ActivTracer GMS LTD</td>
			<td>GMS Co. Ltd Japan</td>
			<td>AC-301A</td>
			<td>Triaxial accelerometer</td>
		</tr>
		<tr>
			<td>ADXL202E dual-accelerometer</td>
			<td>Analog Devices</td>
			<td>ADXL212AEZ</td>
			<td>High precision, low power, complete dual axis accelerometer with signal conditioned, duty cycle modulated outputs, all on a single monolithic IC.</td>
		</tr>
		<tr>
			<td>ENC-03J gyroscope</td>
			<td>Murata Electronics</td>
			<td>ENC-03J</td>
			<td>Vibration Sensors</td>
		</tr>
		<tr>
			<td>DynaPort MiniMod</td>
			<td>MCROBERTS</td>
			<td></td>
			<td>Small and light case containing a tri-axial accelerometer, a rechargeable battery, an USB connection, and raw data storage on a MicroSD card</td>
		</tr>
		<tr>
			<td>MM-2860 Sunhayato</td>
			<td>Sunhayato</td>
			<td>MM-2860</td>
			<td>3-axis accelerometer</td>
		</tr>
		<tr>
			<td>MicroStone MA3-10Ac</td>
			<td>MA3-04AC</td>
			<td>Microstone Co.</td>
			<td>Acceleration sensors</td>
		</tr>
		<tr>
			<td>RT3 Activity monitor</td>
			<td>Abledata</td>
			<td>NA</td>
			<td>Triaxial accelerometer</td>
		</tr>
		<tr>
			<td>Aparito</td>
			<td>aparito</td>
			<td>NA</td>
			<td>Wearables and disease specific mobile apps to deliver patient monitoring outside of the hospital; Elin Davies, Aparito: https://www.aparito.com/</td>
		</tr>
		<tr>
			<td>Docking station</td>
			<td>Sysnav</td>
			<td>SF-000118</td>
			<td></td>
		</tr>
		<tr>
			<td>Sensor</td>
			<td>Sysnav</td>
			<td>SF-000080</td>
			<td></td>
		</tr>
		<tr>
			<td>Bracelet 
			(black/grey L) 
			(black/grey S) (black/yellow L) (black/yellow S)</td>
			<td>Sysnav</td>
			<td>ZZ-000093 ZZ-000094 ZZ-000247 ZZ-000248</td>
			<td></td>
		</tr>
		<tr>
			<td>Patient manual</td>
			<td>Sysnav</td>
			<td>FD-000086</td>
			<td></td>
		</tr>
		<tr>
			<td>Ethernet cable (2 m max.)</td>
			<td>Sysnav</td>
			<td>IC-000458</td>
			<td></td>
		</tr>
		<tr>
			<td>Power cable 
			(EU) 
			(UK) 
			(US)</td>
			<td>Sysnav</td>
			<td>ZE-000440 ZE-000441 ZE-000442</td>
			<td></td>
		</tr>
		<tr>
			<td>Power supply unit</td>
			<td>Sysnav</td>
			<td>ZE-000443</td>
			<td></td>
		</tr>
		<tr>
			<td>Ankle strap</td>
			<td>Sysnav</td>
			<td>ZZ-000462</td>
			<td></td>
		</tr>
		<tr>
			<td>Small bag</td>
			<td>Sysnav</td>
			<td>ZZ-000033</td>
			<td></td>
		</tr>
	</tbody>
</table>

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.

Data presented here were acquired during clinical trials approved by the ethics committee and the French Regulatory Agency. All patient representatives signed an informed consent.
This WMIS was first used in a clinical study setting in 2012 for controlled and home-based monitoring of upper-limb movements in non-ambulant DMD patients (NCT01611597), which demonstrated the autonomy and feasibility of device use10<...

Watch this Scientific Journal Video about Home-Based Monitor for Gait and Activity Analysis at JoVE.com

Home-Based Monitor for Gait and Activity Analysis

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 ...

Our innovative device uses Magneto Inertial sensors to precisely capture movements and dedicated algorithms to precisely qualify and quantify the motor activity of specific subject within a non-controlled environment. The use of a continuous in-home-based activity measurement device, allows an objective, and more globally representative assessment of both ambulant and non-ambulant subjects. This device was initially developed to precisely measure the activity of neuromuscular patients.But, it can be used for a broad variety of pathologies in patients suffering movement, gate, and activity disruptions. Currently, the device is being used as an exploratory outcome measure in clinical trials for neuromuscular and neurologic diseases. Visual demonstration allow an accurate explanation of the main steps of the device set-up, including sense of placement and orientation, according to the required configuration.To prepare for a participant's visit to the clinical center, first check the suitcase contents. The suitcase should contain the docking station to plug in the sensors during the night for data uploading onto a USB key and the battery recharging;The power cord, divided into two pieces, to connect the docking station to a power supply;The ethernet cable to permit interface with a router;the two sensors to permit daily activity recording;one participant manual, and one task reminder, bands for attachment of the sensors depending on the chosen configuration and ambulatory status of the participant;a second participant manual and an investigator manual, a screw driver to enable replacement of the USB key;and blank USB keys. Then print and prepare the assignment form to record the assignment of a device to a participant, to enable data reconciliation with a subject ID.To position the wearable Magneto Inertial sensor on an ambulant participant, fix one sensor on the wrist of the dominant hand using the provided bracelet, so that the waves are pointing towards the fingers.Place the second sensor on the ankle, on the same side as the wrist sensor, above the external malleolus with the waves pointing in the forward direction. For the ankle-ankle configuration, place one shoe sticker on each sensor, following the curve of the wave, and place the appropriate sensor on each ankle above the external malleolus. The sensors are placed appropriately if the stickers are upright and pointing in the forward direction.To position the wearable Magneto Inertial sensor on a non-ambulant participant, place one sensor on the wrist of the participant's dominant hand using the provided bracelet, so that the waves are pointing towards the fingers. Place the second sensor in the provided bag, and attach the bag to a safe place on the wheelchair. The sensor should fit tightly, but not too much to the wrist and/or the ankle to prevent them from spinning around.Also, the participants should not switch the sensors'positions. After explaining the sensor positions to the participant, explain the daily routine for the sensors use. The first evening, the participant should plug the docking station into the power supply, and attach the docking station to the router, if an internet connection is available.Every evening, the participant should insert the sensors into the docking station. The two Light Emitting Diodes, or LEDs on the docking station, should become orange, to indicate that the sensor batteries are charging, and that the data is being downloaded from the sensors to the USB drive. Every morning, the participant should verify that the LEDs are green, indicating that the sensor batteries are fully charged, and the data has been cleared from the sensor memory.The participant should then remove the sensors from the docking station, and put on the sensors in the configuration demonstrated by the evaluator. The participant should keep the sensors on throughout the day, before placing the sensors back on the docking station at the end of the day. The sensor should be removed, and kept on a safe, firm surface during activities involving water, special medical examinations, or any other activity that could be damaging.At the end of the recording period, the participant should place all of the items neatly back into the suitcase and bring the device back to the clinical center. The participant should then complete a dedicated assignment form. If the docking station cannot be connected to the internet, use the screwdriver to remove the USB drive from the docking station, and replace the drive with a blank USB drive at the end of the recording period.Then send the USB drive to the support team for analysis. At selected time points during the study, have the analyst extract the data from the cloud storage, and analyze the data using a dedicated algorithm, adjusting the analysis periods and the monitoring reports based on the clinical study. The wearable Magneto Inertial sensor allows variables, such as the norm of angular velocity, the ratio of the vertical component of the acceleration to the overall acceleration, the elevation rate, and the computed power to be identified for the clinical characterization of the upper limb activity of the participants in a controlled environment.The device also allows the identification and measurement of each single stride of a participant over a long time period, enabling analysis of the distribution of all of the captured strides, as well as the calculation of the centile of stride speed and length. Several parameters measurable by this wearable Magneto Inertial sensor, are less sensitive to change than the 95th centile stride velocity, but are closely related to quality of life, such as the distance walked per hour, and the number of falls per hour. Testing of the precision of the gate trajectory in controlled participants using an optokinetic system confirmed an excellent agreement between the trajectories measured by the optokinetic system, and the Magneto Inertial sensor.Remember to use the device according to the manual and clinical trial requirements, and to make sure each participant meets the eligibility criteria for using the device. Additional applications of our device include the evolution of patients with multiple sclerosis or Parkinson's disease. In these conditions, connected devices have already been tested, but we're still missing validated, sensitive, and reliable outcome measures that could be qualified by the regulators.

Research

JoVE Journal

Bioengineering

Polymer Microarrays for High Throughput Discovery of Biomaterials

The discovery of novel biomaterials that are optimized for a specific biological application is readily achieved using polymer microarrays, which allows a ...

Self-reporting Scaffolds for 3-Dimensional Cell Culture

Culturing cells in 3D on appropriate scaffolds is thought to better mimic the in vivo microenvironment and increase cell-cell interactions. The resulting ...

Analysis of Tubular Membrane Networks in Cardiac Myocytes from Atria and Ventricles

In cardiac myocytes a complex network of membrane tubules - the transverse-axial tubule system (TATS) - controls deep intracellular signaling functions. ...

Hybrid &#181;CT-FMT imaging and image analysis

Hybrid  &#181;CT-FMT imaging and image analysis

Fluorescence-mediated tomography (FMT) enables longitudinal and quantitative determination of the fluorescence distribution in vivo and can be used to ...

Sensitive Detection of Proteopathic Seeding Activity with FRET Flow Cytometry

Increasing evidence supports transcellular propagation of toxic protein aggregates, or proteopathic seeds, as a mechanism for the initiation and ...

Optical Control of Living Cells Electrical Activity by Conjugated Polymers

Hybrid interfaces between organic semiconductors and living tissues represent a new tool for in-vitro and in-vivo applications. In particular, conjugated ...

2D and 3D Matrices to Study Linear Invadosome Formation and Activity

Cell adhesion, migration, and invasion are involved in many physiological and pathological processes. For example, during metastasis formation, tumor ...

Nanosensors to Detect Protease Activity In Vivo for Noninvasive Diagnostics

Nanosensors to Detect Protease Activity In Vivo for Noninvasive Diagnostics

Proteases are multi-functional enzymes that specialize in the hydrolysis of peptide-bonds and control broad biological processes including homeostasis and ...

Manufacturing of a Nafion-coated, Reduced Graphene Oxide/Polyaniline Chemiresistive Sensor to Monitor pH in Real-time During Microbial Fermentation

Here, we report the engineering of a solid-state micro pH sensor based on polyaniline-functionalized, electrochemically reduced graphene oxide (ERGO-PA). ...

Colorimetric Analysis of Alkaline Phosphatase Activity in S. aureus Biofilm

Colorimetric Analysis of Alkaline Phosphatase Activity in S. aureus Biofilm

Alkaline phosphatase (ALP) is a common enzyme expressed in both prokaryotic and eukaryotic cells. It catalyzes the hydrolysis of phosphate monoesters from ...