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Grasping Rehabilitation With Functional Electrical Stimulation Garment (GarmentGrasp)

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ClinicalTrials.gov Identifier: NCT03658798
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Milos Popovic, 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.

Condition or disease Intervention/treatment Phase
Stroke Spinal Cord Injuries Procedure: Functional Electrical Stimulation Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participant will be compared to themselves in a "pre-post" analysis
Masking: None (Open Label)
Masking Description: No masking of the intervention to participant or assessor because there is only 1 arm.
Primary Purpose: Treatment
Official Title: Testing the Efficacy of Garment-embedded Electrodes for Functional Electrical Stimulation: Training of Individuals With Upper-limb Paralysis.
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : July 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: FES-Garment
All participants will take part in 40 sessions of 1 hour of Functional Electrical Stimulation
Procedure: Functional Electrical Stimulation
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.




Primary Outcome Measures :
  1. Wolf Motor Function Test [ Time Frame: Baseline ]

    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).


  2. Toronto Rehabilitation Institute Hand Function Test [ Time Frame: Baseline ]
    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.

  3. Wolf Motor Function Test [ Time Frame: End study, after 14 weeks on average ]

    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


  4. 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



Secondary Outcome Measures :
  1. Functional Independence Measure (FIM) [ Time Frame: Baseline ]

    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.


  2. Functional Independence Measure (FIM) [ Time Frame: End study, after 14 weeks on average ]

    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


  3. Spinal Cord Independence Measure [ Time Frame: Baseline ]

    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.


  4. Spinal Cord Independence Measure [ Time Frame: End study, after 14 weeks on average ]

    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


  5. Grip strength [ Time Frame: Baseline ]

    Average of the 3 maximal grip strength recorded with a Digital Grip Hand Dynamometer.

    For both group.


  6. Grip strength [ Time Frame: End study, after 14 weeks on average ]
    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.

  7. Set-up time [ Time Frame: During the procedure ]
    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.

  8. Execution of the training tasks with FES [ Time Frame: During the procedure ]
    Record in the CRF of the weight of bottle lifted at shoulder level while receiving FES.

  9. Execution of the training tasks without FES [ Time Frame: During the procedure ]
    Record in the case report form (CRF) of the highest weight of bottle lifted at shoulder level without delivery of FES.


Other Outcome Measures:
  1. Participant's feedback [ Time Frame: During the procedure ]
    Record in the CRF participant's feedback regarding the FES garments.

  2. Adverse events [ Time Frame: During the procedure ]
    Record in the CRF pain and other unexpected events that happen during and after FES- garment therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658798


Contacts
Contact: Bastien M Moineau, PhD 4165973422 ext 6213 bastien.moineau@uhn.ca
Contact: Vera Zivanovic, MD 4165973422 ext 6119 Vera.Zivanovic@uhn.ca

Locations
Canada, Ontario
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M5H 3V9
Contact: Esther Oostdick    4165973422 ext 6302    Esther.Oostdyk@uhn.ca   
Contact: Azim Rashidi    4165973422 ext 6213    azimrashidi@yahoo.com   
Principal Investigator: Milos R Popovic, PhD         
Sub-Investigator: Bastien M Moineau, PhD         
Sponsors and Collaborators
Milos Popovic
Investigators
Principal Investigator: Milos R Popovic, PhD Toronto Rehabilitation Institute

Publications:
Responsible Party: Milos Popovic, Research Director, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT03658798     History of Changes
Other Study ID Numbers: 16-6348
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This aspect hasn't been discussed with all collaborators of the study.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Milos Popovic, Toronto Rehabilitation Institute:
Functional Electrical Stimulation
Neuroprosthesis
Rehabilitation

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries