StrokeSUPERNCT03903770
Personalized Upper Extremity Rehabilitation for Persons With Stroke
A study testing Upper extremity rehabilitation in people with Stroke, run by McGill University at 2 sites in Canada.
Trial summary
Approximately 80% of individuals with chronic stroke present with long lasting upper extremity (UE) impairments. Advances in rehabilitation technology, such as robotics, virtual reality (VR) and neuromuscular electrical stimulation (NMES), have separately demonstrated their effectiveness in improving UE function of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Upper extremity rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2018to 1 Dec 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic or hemorrhagic stroke
- moderate to severe UE impairment (score between 2 and 4 out of 7 on the Chedoke-McMaster each of the arm and hand components
- at least 3 months post stroke
- no longer receiving rehabilitation services.
Who cannot join
- medical instability
- marked cognitive deficits (MiniCog score 2 or lower)
- uncorrected visual impairments
- shoulder pain that would limit participation in the study
- severe spasticity at the affected UE
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Jewish Rehabilitation Hospital
Laval, Quebec, H7V1R2
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: Personalized Upper Extremity Rehabilitation for Persons With Moderate and Severe Impairments Due to Stroke
Approximately 80% of individuals with chronic stroke present with long lasting upper extremity (UE) impairments. Advances in rehabilitation technology, such as robotics, virtual reality (VR) and neuromuscular electrical stimulation (NMES), have separately demonstrated their effectiveness in improving UE function of individuals with stroke. The potential to influence recovery may be further enhanced by combining these modalities in order to target motor deficits of the individual. Research has shown that not all persons with stroke may be able to recover hand function. In particular, such recovery depends on the integrity of the corticospinal tract (CST), which links the motor areas of the brain to the UE (and hand) musculature. Instead of using a 'one-size-fits-all' approach to UE rehabilitation, CST integrity will be assessed through transcranial magnetic stimulation (TMS), a non-invasive approach, and match the intervention to the individual's specific impairments. The perSonalized UPper Extremity Rehabilitation (SUPER) intervention is proposed, which combines robotics, VR activities, and NMES. The objectives of this study are to determine the feasibility of the SUPER intervention in individuals with moderate/severe stroke. Stroke participants will receive a 5-week intervention (3x per week) combining robotic therapy and VR activities, based on their functional level. Those with low potential for hand recovery will receive an intervention focussing on elbow and shoulder movements. For those with a good potential for hand recovery, the last 30 minutes of the robotic or VR session will be complemented by muscle-triggered NMES. Feasibility indicators associated with process, resources, management and treatment will be measured. Outcomes of UE and hand function will include the Fugl-Meyer upper extremity assessment, the Box and Block test and the ABILHAND. It is expected that feasibility criteria will be met and that the SUPER intervention will lead to significant improvements in UE impairment compared to a waitlist group.
- Conditions
- Stroke
- Being tested
- Upper extremity rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity rehabilitationDevice
Participants receive the SUPER intervention 3 times per week for 1 hr, during 4 weeks. For participants with a low recovery potential for hand function, the SUPER interventions consists in robot-assisted reaching movements and unilateral and bilateral VR activities. The robot-assisted activity consists of a reaching task to six targets placed at maximal reach distance. For the VR activity, we use a reach and grasp VR activity based on a shopping task. Participants with good potential for hand recovery also receive 30 min of electromyography-triggered muscle stimulation, combined with the VR activity. The muscle stimulation is triggered when the participant attempts to grasp a virtual object and helps with hand opening movements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Upper extremity rehabilitation Receives: Device: Upper extremity rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks
A performance-based measure of UE impairment describing motor recovery
Measured: 6 weeks
Change from baseline Box and Blocks Test at 6 weeks
A measure of gross motor dexterity
Measured: 6 weeks
Change from baseline ABILHAND at 6 weeks
A questionnaire to assess active function of the upper limbs with 23 activities, rated as impossible, difficult or easy. The scale is scored through Rasch analysis, providing a total score ranging from -6 to +6, with higher scores indicating a lower degree of upper extremity impairment.
Measured: 6 weeks
Secondary outcomes (3)
Change from baseline Motor Activity Log at 6 weeks
A questionnaire rating the quality and frequency of use of the upper extremity in 14 everyday tasks. Each task is rated on two scales: quantity, assessing how much the affected extremity is used in the task; and quality, assessing how well does the affected extremity perform in the task. A 0 to 5 scale is used for quantity and quality (0 = not at all; 5 = same as before stroke). Answers are averaged for each sub scale and a percentage is calculated. A higher score indicates lower level of impairment.
Measured: 6 weeks
Change from baseline Grip Strength at 6 weeks
Maximal hand grip strength measured with a dynamometer
Measured: 6 weeks
Change from baseline Stroke Impact Scale at 6 weeks
A stroke-specific health status measure featuring 16 items capturing daily activities. This scale has 8 sub-scales, evaluating: strength, hand function, mobility, activities of daily living, emotion, memory, communication and social participation. Each is rated on a 0 to 100 range (100 corresponding to least impact of stroke). An overall score is also calculated (average of sub-scales).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Sep 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- single-subject with multiple baselines (AAAB)
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Archambault, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903770
- Sponsor's protocol ID
- CRIR-1271-1017
- Acronym
- SUPER
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norouzi-Gheidari N, Archambault PS, Monte-Silva K, Kairy D, Sveistrup H, Trivino M, Levin MF, Milot MH. Feasibility and preliminary efficacy of a combined virtual reality, robotics and electrical stimulation intervention in upper extremity stroke rehabilitation. J Neuroeng Rehabil. 2021 Apr 14;18(1):61. doi: 10.1186/s12984-021-00851-1.
PubMed 33853614
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Upper Extremity Rehabilitation for Persons With Moderate and Severe Impairments Due to Stroke
- ClinicalTrials.gov ID
- NCT03903770
- Acronym / sponsor ID
- SUPER / CRIR-1271-1017
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 4 Apr 2019 (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.
Approximately 80% of individuals with chronic stroke present with long lasting upper extremity (UE) impairments. Advances in rehabilitation technology, such as robotics, virtual reality (VR) and neuromuscular electrical stimulation (NMES), have separately demonstrated their effectiveness in improving UE function of individuals with stroke. The potential to influence recovery may be further enhanced by combining these modalities in order to target motor deficits of the individual. Research has shown that not all persons with stroke may be able to recover hand function. In particular, such recovery depends on the integrity of the corticospinal tract (CST), which links the motor areas of the brain to the UE (and hand) musculature. Instead of using a 'one-size-fits-all' approach to UE rehabilitation, CST integrity will be assessed through transcranial magnetic stimulation (TMS), a non-invasive approach, and match the intervention to the individual's specific impairments. The perSonalized UPper Extremity Rehabilitation (SUPER) intervention is proposed, which combines robotics, VR activities, and NMES. The objectives of this study are to determine the feasibility of the SUPER intervention in individuals with moderate/severe stroke. Stroke participants will receive a 5-week intervention (3x per week) combining robotic therapy and VR activities, based on their functional level. Those with low potential for hand recovery will receive an intervention focussing on elbow and shoulder movements. For those with a good potential for hand recovery, the last 30 minutes of the robotic or VR session will be complemented by muscle-triggered NMES. Feasibility indicators associated with process, resources, management and treatment will be measured. Outcomes of UE and hand function will include the Fugl-Meyer upper extremity assessment, the Box and Block test and the ABILHAND. It is expected that feasibility criteria will be met and that the SUPER intervention will lead to significant improvements in UE impairment compared to a waitlist group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-subject with multiple baselines (AAAB)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Upper extremity rehabilitationUpper extremity rehabilitation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ischemic or hemorrhagic stroke
- moderate to severe UE impairment (score between 2 and 4 out of 7 on the Chedoke-McMaster each of the arm and hand components
- at least 3 months post stroke
- no longer receiving rehabilitation services.
Key exclusion criteria (5 listed)
- medical instability
- marked cognitive deficits (MiniCog score 2 or lower)
- uncorrected visual impairments
- shoulder pain that would limit participation in the study
- severe spasticity at the affected UE
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 |
|---|---|---|
| Upper extremity rehabilitationParticipants receive the SUPER intervention 3 times per week for 1 hr, during 4 weeks. For participants with a low recovery potential for hand function, the SUPER interventions consists in robot-assisted reaching movements and unilateral and bilateral VR activities. The robot-assisted activity consists of a reaching task to six targets placed at maximal reach distance. For the VR activity, we use a reach and grasp VR activity based on a shopping task. Participants with good potential for hand recovery also receive 30 min of electromyography-triggered muscle stimulation, combined with the VR activity. The muscle stimulation is triggered when the participant attempts to grasp a virtual object and helps with hand opening movements. | Device | Intervention |
Primary outcome
Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks
Time frame: 6 weeks
A performance-based measure of UE impairment describing motor recovery
Change from baseline Box and Blocks Test at 6 weeks
Time frame: 6 weeks
A measure of gross motor dexterity
Change from baseline ABILHAND at 6 weeks
Time frame: 6 weeks
A questionnaire to assess active function of the upper limbs with 23 activities, rated as impossible, difficult or easy. The scale is scored through Rasch analysis, providing a total score ranging from -6 to +6, with higher scores indicating a lower degree of upper extremity impairment.
3 secondary outcomes
Change from baseline Motor Activity Log at 6 weeks
Time frame: 6 weeks
Change from baseline Grip Strength at 6 weeks
Time frame: 6 weeks
Change from baseline Stroke Impact Scale at 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 33853614Norouzi-Gheidari N, Archambault PS, Monte-Silva K, Kairy D, Sveistrup H, Trivino M, Levin MF, Milot MH. Feasibility and preliminary efficacy of a combined virtual reality, robotics and electrical stimulation intervention in upper extremity stroke rehabilitation. J Neuroeng Rehabil. 2021 Apr 14;18(1):61. doi: 10.1186/s12984-021-00851-1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity rehabilitation in people with Stroke, run by McGill University at 2 sites 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 5 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: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline Fugl-Meyer Assessment (Upper extremity section) at 6 weeks (time frame: 6 weeks). The study lists 3 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 NCT03903770, which also lists 1 linked publication.
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 19 Feb 2020.