- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03658798
Grasping Rehabilitation With Functional Electrical Stimulation Garment (GarmentGrasp)
Testing the Efficacy of Garment-embedded Electrodes for Functional Electrical Stimulation: Training of Individuals With Upper-limb Paralysis.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5H 3V9
- Toronto Rehabilitation Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FES-Garment
All participants will take part in 40 sessions of 1 hour of Functional Electrical Stimulation
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wolf Motor Function Test
Time Frame: Baseline
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For participants who had a stroke. A series of movement and object manipulations video-taped, timed, and rated for their quality of execution and success. The TRI-Hand Function Test is a gross motor function test used to assess upper extremity function in SCI. There are two components of the test an object manipulation component and a strength measurement component. The Wolf Motor Function Test is validated in stroke and it consists of performing 17 tasks (moving the hand on certain spots, handling daily life objects). The evaluator scores the quality of movement (e.g. 0 = does not attempt; 3. = movement with synergy, effort, at low speed; 5 = movement appears to be normal). |
Baseline
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Toronto Rehabilitation Institute Hand Function Test
Time Frame: Baseline
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For participants who had a spinal cord injury.
A series of movement and object manipulations video-taped, timed, and rated for their quality of execution and success.
|
Baseline
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Wolf Motor Function Test
Time Frame: End study, after 14 weeks on average
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For participants who had a stroke. A series of movement and object manipulations video-taped, timed, and rated for their quality of execution and success. Re-measured after the participant completed the 40 sessions |
End study, after 14 weeks on average
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Toronto Rehabilitation Institute Hand Function Test
Time Frame: End study, after 14 weeks on average
|
For participants who had a spinal cord injury. A series of movement and object manipulations video-taped, timed, and rated for their quality of execution and success. Re-measured after the participant completed the 40 sessions |
End study, after 14 weeks on average
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Independence Measure (FIM)
Time Frame: Baseline
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The FIM is a 12 item ordinal scale used to assess progress during rehabilitation and measures independent performance in various domains of activities of daily living. FIM score ranges from 12 to 84 FIM will be administered only in participants with Stroke. |
Baseline
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Functional Independence Measure (FIM)
Time Frame: End study, after 14 weeks on average
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The FIM is a 12 item ordinal scale used to assess progress during rehabilitation and measures independent performance in various domains of activities of daily living. FIM score ranges from 12 to 84 FIM will be administered only in participants with Stroke. Re-measured after the participant completed the 40 sessions |
End study, after 14 weeks on average
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Spinal Cord Independence Measure
Time Frame: Baseline
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SCIM is a disability scale that has been specifically developed to evaluate functional outcomes in patients with SCI. It assess function in three core areas 1. Self care 2.Respiration and 3.Mobility. The SCIM scores range from 0 to 100 points. SCIM will be administered only in participants with SCI. |
Baseline
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Spinal Cord Independence Measure
Time Frame: End study, after 14 weeks on average
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SCIM is a disability scale that has been specifically developed to evaluate functional outcomes in patients with SCI. It assess function in three core areas 1. Self care 2.Respiration and 3.Mobility. The SCIM scores range from 0 to 100 points. SCIM will be administered only in participants with SCI. Re-measured after the participant completed the 40 sessions |
End study, after 14 weeks on average
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Grip strength
Time Frame: Baseline
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Average of the 3 maximal grip strength recorded with a Digital Grip Hand Dynamometer. For both group. |
Baseline
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Grip strength
Time Frame: End study, after 14 weeks on average
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Average of the 3 maximal grip strength recorded with a Digital Grip Hand Dynamometer.
Re-measured after the participant completed the 40 sessions For both group.
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End study, after 14 weeks on average
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Set-up time
Time Frame: During the procedure
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Record with a stop watch the time required to 1. put on the FES-garment, 2. wet the electrodes, and 3. select the appropriate stimulation intensity.
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During the procedure
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Execution of the training tasks with FES
Time Frame: During the procedure
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Record in the CRF of the weight of bottle lifted at shoulder level while receiving FES.
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During the procedure
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Execution of the training tasks without FES
Time Frame: During the procedure
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Record in the case report form (CRF) of the highest weight of bottle lifted at shoulder level without delivery of FES.
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During the procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milos R Popovic, PhD, Toronto Rehabilitation Institute
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: Artif Organs. 2011 Jun;35(6):674. Furlan, Julio [corrected to Furlan, Julio C].
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-6348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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