StrokeGarmentGraspNCT03658798
Grasping Rehabilitation With Functional Electrical Stimulation Garment
A study testing Functional Electrical Stimulation in people with Stroke and Spinal Cord Injuries, run by Milos Popovic at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries
- What is being tested?
- Functional Electrical Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2017to 12 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of Garment-embedded Electrodes for Functional Electrical Stimulation: Training of Individuals With Upper-limb Paralysis.
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.
Read the 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.
- Conditions
- Stroke, Spinal Cord Injuries
- Being tested
- Functional Electrical Stimulation
- Keywords
- Functional Electrical Stimulation, Neuroprosthesis, Rehabilitation
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| FES-Garment | Experimental | All participants will take part in 40 sessions of 1 hour of Functional Electrical Stimulation Receives: Procedure: Functional Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: End study, after 14 weeks on average
Secondary outcomes (9)
Functional Independence Measure (FIM)
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.
Measured: Baseline
Functional Independence Measure (FIM)
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
Measured: End study, after 14 weeks on average
Spinal Cord Independence Measure
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.
Measured: Baseline
Spinal Cord Independence Measure
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
Measured: End study, after 14 weeks on average
Grip strength
Average of the 3 maximal grip strength recorded with a Digital Grip Hand Dynamometer.
For both group.
Measured: Baseline
Grip strength
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.
Measured: End study, after 14 weeks on average
Set-up time
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.
Measured: During the procedure
Execution of the training tasks with FES
Record in the CRF of the weight of bottle lifted at shoulder level while receiving FES.
Measured: During the procedure
Execution of the training tasks without FES
Record in the case report form (CRF) of the highest weight of bottle lifted at shoulder level without delivery of FES.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start2 Oct 2017
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
Why it stopped: Funds have not been received
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participant will be compared to themselves in a "pre-post" analysis
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milos Popovic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Milos Popovic, Toronto Rehabilitation Institute
- Investigators
- Milos R Popovic, PhD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658798
- Sponsor's protocol ID
- 16-6348
- Acronym
- GarmentGrasp
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2018
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This aspect hasn't been discussed with all collaborators of the study.
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.
PubMed 26193273Kapadia 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.
PubMed 21401662Kawashima 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.
PubMed 24381377Eraifej 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.
PubMed 28245858
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Garment-embedded Electrodes for Functional Electrical Stimulation: Training of Individuals With Upper-limb Paralysis.
- ClinicalTrials.gov ID
- NCT03658798
- Acronym / sponsor ID
- GarmentGrasp / 16-6348
- Conditions
- Stroke, Spinal Cord Injuries
- Keywords
- Functional Electrical Stimulation, Neuroprosthesis, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funds have not been received
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Milos PopovicUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participant will be compared to themselves in a "pre-post" analysis
| Arm | Type | Receives |
|---|---|---|
| FES-Garment | Experimental | Procedure: Functional Electrical StimulationAll participants will take part in 40 sessions of 1 hour of Functional Electrical Stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical StimulationStudy 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. | Procedure or surgery | FES-Garment |
Primary outcome
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).
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.
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
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
9 secondary outcomes
Functional Independence Measure (FIM)
Time frame: Baseline
Functional Independence Measure (FIM)
Time frame: End study, after 14 weeks on average
Spinal Cord Independence Measure
Time frame: Baseline
Spinal Cord Independence Measure
Time frame: End study, after 14 weeks on average
Grip strength
Time frame: Baseline
Grip strength
Time frame: End study, after 14 weeks on average
Set-up time
Time frame: During the procedure
Execution of the training tasks with FES
Time frame: During the procedure
Execution of the training tasks without FES
Time frame: During the procedure
Results and safety
The study was stopped early (reason given: Funds have not been received). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Background: PubMed 26193273Zhou 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.
- Background: PubMed 21401662Kapadia 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.
- Background: PubMed 24381377Kawashima 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.
- Background: PubMed 28245858Eraifej 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.
- Individual participant dataSharing planned: Undecided. This aspect hasn't been discussed with all collaborators of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milos R Popovic, PhD principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation in people with Stroke and Spinal Cord Injuries, run by Milos Popovic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funds have not been received). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03658798, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.