Grasping Rehabilitation With Functional Electrical Stimulation Garment

Testing the Efficacy of Garment-embedded Electrodes for Functional Electrical Stimulation: Training of Individuals With Upper-limb Paralysis.

Sponsors

Lead Sponsor: Milos Popovic

Source Toronto Rehabilitation Institute
Brief Summary

This study tests the feasibility, safety and efficacy of garments embedding conductive electrodes (FES-shirt) for the independent delivery of functional electrical stimulation (FES). 12 people with SCI and 12 people with stroke who have some degree of arm paralysis will receive 40 hours of FES with these FES-shirt. The ability to use the FES-shirts and the improvement in function while receiving FES will indicate the immediate benefits. Their functional capabilities will be measured before and after 40 FES sessions to evaluate the carry-over effects.

Detailed Description

Spinal cord injury (SCI) and stroke can result in paralysis of arm and hand muscles preventing people from being able to use them in day to day activities, which can greatly impact quality of life. Functional electrical stimulation (FES) can activate the paralyzed muscles by sending a low energy electrical current through the skin. FES has been shown to improve the ability to control muscles in previous studies.In current simulators individual adhesive gel electrodes are positioned on the appropriate muscles to produce functional movements.This is time consuming and requires a therapist to guide electrode placement,besides the cables interfere with the individuals ability to perform functional movements with the FES.To approach this issue, we designed prototype shirts embedding all the necessary electrodes and wires to stimulate muscles around the hand, elbow and shoulder.

24 individuals with difficulty performing routine day to day activities with their upper extremities will be recruited to the study: 12 people with SCI and 12 people with stroke. Each participant will receive a custom designed FES shirt made based on individual participant body measurements and optimal electrode positions identified with standard gel electrodes.Study participants will receive 40 sessions of intervention, 3 to 5 times a week over 2 to 3 months. Each session will be one hour in duration and participant will receive functional electrical stimulation therapy through this customized shirt. They will have to don, activate, and doff the garment as independently as possible. The exercises conducted will be defined by the investigator based on the functional status of the participant and eventual progress.

Participants will be evaluated before and after the intervention using functional tests and questionnaires Participants will be invited to give their opinions on the shirt so that the researchers can improve its features.

Overall Status Unknown status
Start Date October 2, 2017
Completion Date July 17, 2020
Primary Completion Date July 17, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Wolf Motor Function Test Baseline
Toronto Rehabilitation Institute Hand Function Test Baseline
Wolf Motor Function Test End study, after 14 weeks on average
Toronto Rehabilitation Institute Hand Function Test End study, after 14 weeks on average
Secondary Outcome
Measure Time Frame
Functional Independence Measure (FIM) Baseline
Functional Independence Measure (FIM) End study, after 14 weeks on average
Spinal Cord Independence Measure Baseline
Spinal Cord Independence Measure End study, after 14 weeks on average
Grip strength Baseline
Grip strength End study, after 14 weeks on average
Set-up time During the procedure
Execution of the training tasks with FES During the procedure
Execution of the training tasks without FES During the procedure
Enrollment 24
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Functional Electrical Stimulation

Description: Study participants will receive 40 sessions of intervention, 3 to 5 times a week over 2 to 3 months. Each session will be one hour in duration and participant will receive functional electrical stimulation therapy with their customized shirt. During therapy participants will be expected to carry out functional movements with assistance from the FES Garment.Participants will be expected to don, activate, and doff the garment as independently as possible. The exercises conducted will be defined by the investigator based on the functional status of the participant and eventual progress.

Arm Group Label: FES-Garment

Eligibility

Criteria:

Inclusion Criteria:

- Complete and Incomplete C4-C7 SCI or brain vascular stroke (hemorrhagic or ischemic)

- Upper-limb paralysis to the extent that it interferes with the participants ability to perform activities of daily living independently.

- More than 6 months post injury at the time of recruitment and should have been discharged from initial post-acute rehabilitation

- Able to communicate verbally and read in English

Exclusion Criteria:

- Implanted electronic devices such as: defibrillator, stimulator, insulin pump, baclofen pump, pace maker

- Contracture and/or pain preventing shoulder elevation above 90 degrees.

- Body mass index > 30 kg/m2 (severe obesity)

- Known abdominal or aortic aneurysm

- Known atrial of ventricular arrhythmia, unstable hypertension,

- Diabetes with a history of recurrent hypoglycemic episodes

- Cognitive impairments, such as co-morbid brain injury, depression, and/or mental illness preventing an active participation in the study

- Known contact allergy to silver

- Grade three pressure sore or cellulitis in the region intended to be tested

- Body jewelry or tattoos in the area to be stimulated (between sites of the electrodes and/or at less than 2 inch distance from electrodes).

Specifically for participants with SCI:

- Recurrent episodes of orthostatic hypotension preventing a prolonged seated position, or recurrent uncontrolled autonomic dysreflexia episodes

- Prior history of myocardial infarction or stroke

Specifically for participants with Stroke:

- Hemianopia, body hemineglect and/or aphasia preventing an efficient communication with researcher and interaction with the garment and the objects.

- Prior history of spinal cord injury

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Milos R Popovic, PhD Principal Investigator Toronto Rehabilitation Institute
Overall Contact

Last Name: Bastien M Moineau, PhD

Phone: 4165973422

Phone Ext.: 6213

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Toronto Rehabilitation Institute Esther Oostdick 4165973422 6302 [email protected] Milos R Popovic, PhD Principal Investigator Bastien M Moineau, PhD Sub-Investigator
Location Countries

Canada

Verification Date

August 2018

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Toronto Rehabilitation Institute

Investigator Full Name: Milos Popovic

Investigator Title: Research Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: FES-Garment

Type: Experimental

Description: All participants will take part in 40 sessions of 1 hour of Functional Electrical Stimulation

Acronym GarmentGrasp
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Participant will be compared to themselves in a "pre-post" analysis

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: No masking of the intervention to participant or assessor because there is only 1 arm.

Source: ClinicalTrials.gov