Grasping Rehabilitation With Functional Electrical Stimulation Garment (GarmentGrasp)

• ClinicalTrials.gov Identifier: NCT03658798
• Recruitment Status: Terminated
• First Posted: September 5, 2018
• Last Update Posted: September 15, 2022
• Sponsor: Milos Popovic
• Information provided by (Responsible Party): Milos Popovic, Toronto Rehabilitation Institute

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: September 12, 2022
• Actual Study Completion Date: September 12, 2022

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Canada, Ontario

Toronto Rehabilitation Institute

Toronto, Ontario, Canada, M5H 3V9

Sponsors and Collaborators

Milos Popovic

Investigators

• Principal Investigator: Milos R Popovic, PhD; Toronto Rehabilitation Institute

More Information

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.

• Responsible Party: Milos Popovic, Research Director, Toronto Rehabilitation Institute
• ClinicalTrials.gov Identifier: NCT03658798
• Other Study ID Numbers: 16-6348
• First Posted: September 5, 2018
• Last Update Posted: September 15, 2022
• Last Verified: September 2022

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