Clinical trial NCT03658798: Grasping Rehabilitation With Functional Electrical Stimulation Garment
Official title: Testing the Efficacy of Garment-embedded Electrodes for Functional Electrical Stimulation: Training of Individuals With Upper-limb Paralysis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Spinal Cord Injuries
Keywords: Functional Electrical Stimulation
Neuroprosthesis
Rehabilitation
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participant will be compared to themselves in a "pre-post" analysis
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wolf Motor Function Test
timeFrame: Baseline
measure: Toronto Rehabilitation Institute Hand Function Test
timeFrame: Baseline
measure: Wolf Motor Function Test
timeFrame: End study, after 14 weeks on average
measure: Toronto Rehabilitation Institute Hand Function Test
timeFrame: End study, after 14 weeks on average
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: Baseline
measure: Functional Independence Measure (FIM)
timeFrame: End study, after 14 weeks on average
measure: Spinal Cord Independence Measure
timeFrame: Baseline
measure: Spinal Cord Independence Measure
timeFrame: End study, after 14 weeks on average
measure: Grip strength
timeFrame: Baseline
measure: Grip strength
timeFrame: End study, after 14 weeks on average
measure: Set-up time
timeFrame: During the procedure
measure: Execution of the training tasks with FES
timeFrame: During the procedure
measure: Execution of the training tasks without FES
timeFrame: During the procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Milos R Popovic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou H, Lu Y, Chen W, Wu Z, Zou H, Krundel L, Li G. Stimulating the Comfort of Textile Electrodes in Wearable Neuromuscular Electrical Stimulation. Sensors (Basel). 2015 Jul 16;15(7):17241-57. doi: 10.3390/s150717241.
citation: Kapadia NM, Zivanovic V, Furlan JC, Craven BC, McGillivray C, Popovic MR. Functional electrical stimulation therapy for grasping in traumatic incomplete spinal cord injury: randomized control trial. Artif Organs. 2011 Mar;35(3):212-6. doi: 10.1111/j.1525-1594.2011.01216.x.
citation: Kawashima N, Popovic MR, Zivanovic V. Effect of intensive functional electrical stimulation therapy on upper-limb motor recovery after stroke: case study of a patient with chronic stroke. Physiother Can. 2013 Winter;65(1):20-8. doi: 10.3138/ptc.2011-36.
citation: Eraifej J, Clark W, France B, Desando S, Moore D. Effectiveness of upper limb functional electrical stimulation after stroke for the improvement of activities of daily living and motor function: a systematic review and meta-analysis. Syst Rev. 2017 Feb 28;6(1):40. doi: 10.1186/s13643-017-0435-5.