Grasping Rehabilitation With Functional Electrical Stimulation Garment

NCT03658798 | Terminated

• 1 other identifier: 16-6348
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Spinal Cord Injuries

Keywords

Functional Electrical Stimulation; Neuroprosthesis; Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Wolf Motor Function Test

  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

• Toronto Rehabilitation Institute Hand Function Test

  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

• Wolf Motor Function Test

  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

• Toronto Rehabilitation Institute Hand Function Test

  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 Outcomes (9)

• 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

Study Arms (1)

FES-Garment

EXPERIMENTAL

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

Procedure: Functional Electrical Stimulation

Interventions

Functional Electrical Stimulation PROCEDURE

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.

FES-Garment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milos Popovic: lead

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5H 3V9, Canada

Location

Related Publications (4)

• 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.

  PMID: 26193273 BACKGROUND

• 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.

  PMID: 21401662 BACKGROUND

• 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.

  PMID: 24381377 BACKGROUND

• 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.

  PMID: 28245858 BACKGROUND

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Milos R Popovic, PhD

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking of the intervention to participant or assessor because there is only 1 arm.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

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

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: September 5, 2018
• Study Start: October 2, 2017
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

CA (1)