StrokeNCT07706621
Pilot Trial of Robotic Hand Therapy After Stroke
A study testing robotic-assisted hand therapy and Action-observation therapy & Education in people with Stroke, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
Trial summary
This pilot study will test whether the GRIP program-a soft robotic glove with virtual-reality training-can improve hand and arm function in adults undergoing inpatient rehabilitation after a recent stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- robotic-assisted hand therapy and Action-observation therapy & Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First unilateral stroke (<6-month post-stroke at enrollment)
- ≥18 years old
- Hand sensorimotor impairments
- Able to understand and follow a two-step instruction
- Admitted to the rehabilitation center and participating in the stroke program
Who cannot join
- Severe spasticity (score ≥3 on the Modified Ashworth Scale)
- Unilateral spatial neglect
- Moderate to severe hand pain
- Significant motor impairment of the fingers (active finger flexion/extension less than 10°)
- Any medical condition that may interfere with participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Institut de réadaptation Gingras-Lindsay-de-Montréal
Montreal, Quebec, H3S 2J4
Marika Demers, PhD, 514 343-6111 ext. 30897, marika.demers@umontreal.ca
Johanne Higgins, PhD, 514 343-6111 ext. 29924, johanne.higgins@umontreal.ca
About this study
Official title: Robotic-Assisted Hand Therapy for Neurorehabilitation in Adults With Hand Sensorimotor Impairments Following a Stroke: A Pilot Randomized Controlled Trial
This pilot study will test whether the GRIP program-a soft robotic glove with virtual-reality training-can improve hand and arm function in adults undergoing inpatient rehabilitation after a recent stroke. About 20 participants will be randomly assigned to either the GRIP program or action-observation therapy with education, in addition to usual care. The study will assess motor improvement, safety, and acceptability over approximately six weeks.
Read the detailed description
The goal of this pilot clinical trial is to determine whether the Glove for Rehabilitation and Interactive Practice (GRIP) program can help improve hand and arm movement in adults who have difficulty using their hand after a recent stroke. The GRIP program uses a soft robotic glove and a virtual reality training platform. It is added to the usual rehabilitation care that participants already receive.
The main questions this study aims to answer are:
- Does the GRIP program help improve hand and arm movement?
- Is the GRIP program safe?
- Do participants find the GRIP program acceptable, comfortable, and engaging? (qualitatively).
Researchers will compare the Glove for Rehabilitation and Interactive Practice (GRIP) program with action-observation therapy and education. Action-observation therapy means watching videos of hand movements and then practicing the same movements. Both groups will also receive their usual rehabilitation care. This study will include about 20 adults who are in an inpatient rehabilitation program after a stroke and who have difficulty using their hand.
- Conditions
- Stroke
- Being tested
- robotic-assisted hand therapy, Action-observation therapy & Education
- Keywords
- stroke, cerebrovascular accident, virtual reality, virtual environment, robotics, exosqueleton, finger, hand, grasp, manual dexterity, prehension, upper limb, motor recovery, subacute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic-assisted hand therapyDevice
Also called hand exosqueleton coupled with a virtual reality program
Participants will receive the GRIP program in addition to usual rehabilitation care. The program uses a soft robotic glove worn on the affected hand together with a non-immersive virtual-reality system that displays hand exercises and a virtual hand that moves with the participant's real movements. The glove can provide assistance or resistance to support grasping practice and strengthening. Training focuses on repeated grasping tasks and strategies to increase use of the affected hand in daily activities. The program includes ten supervised 30-minute sessions over two weeks.
Action-observation therapy & EducationBehavioural
Also called Education, Action-Observation Therapy
Participants will receive usual rehabilitation care plus action-observation therapy (AOT). They will complete ten self-directed 30-minute AOT sessions over two weeks. Each session consists of repeated cycles of watching short videos of hand movements and then attempting to reproduce those movements with the affected hand. Videos will match the grasp types practiced in the intervention arm. Participants will also attend three individual education sessions on post-stroke arm and hand recovery, including strategies to increase use of the affected hand in daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Glove for Rehabilitation and Interactive Practice (GRIP) program | Experimental | 10 participants will be randomly assigned to this group. Receives: Device: robotic-assisted hand therapy |
| Action-Observation Therapy (AOT) and Education | Active comparator | 10 participants will be randomly assigned to this group. Receives: Behavioral: Action-observation therapy & Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
It is a stroke-specific, performance-based impairment index designed to measure upper extremity motor recovery after stroke.
Measured: At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)
Secondary outcomes (1)
Action Research Arm Test
Observational measure that examines upper limb functional recovery
Measured: At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council Canada
- Responsible party
- Principal investigator, Johanne Higgins, Université de Montréal
- Investigators
- Johanne Higgins, PhD, Study director, Université de Montréal, CRIRMarika Demers, PhD, Study director, Université de Montréal, CRIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706621
- Sponsor's protocol ID
- 2026-2490
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Hand Therapy for Neurorehabilitation in Adults With Hand Sensorimotor Impairments Following a Stroke: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07706621
- Acronym / sponsor ID
- 2026-2490
- Conditions
- Stroke
- Keywords
- stroke, cerebrovascular accident, virtual reality, virtual environment, robotics, exosqueleton, finger, hand
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Collaborators
- National Research Council Canada
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Jul 2026 (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 pilot study will test whether the GRIP program-a soft robotic glove with virtual-reality training-can improve hand and arm function in adults undergoing inpatient rehabilitation after a recent stroke. About 20 participants will be randomly assigned to either the GRIP program or action-observation therapy with education, in addition to usual care. The study will assess motor improvement, safety, and acceptability over approximately six weeks.
Detailed description
The goal of this pilot clinical trial is to determine whether the Glove for Rehabilitation and Interactive Practice (GRIP) program can help improve hand and arm movement in adults who have difficulty using their hand after a recent stroke. The GRIP program uses a soft robotic glove and a virtual reality training platform. It is added to the usual rehabilitation care that participants already receive.
The main questions this study aims to answer are:
- Does the GRIP program help improve hand and arm movement?
- Is the GRIP program safe?
- Do participants find the GRIP program acceptable, comfortable, and engaging? (qualitatively).
Researchers will compare the Glove for Rehabilitation and Interactive Practice (GRIP) program with action-observation therapy and education. Action-observation therapy means watching videos of hand movements and then practicing the same movements. Both groups will also receive their usual rehabilitation care. This study will include about 20 adults who are in an inpatient rehabilitation program after a stroke and who have difficulty using their hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glove for Rehabilitation and Interactive Practice (GRIP) program | Experimental | Device: robotic-assisted hand therapy10 participants will be randomly assigned to this group. |
| Action-Observation Therapy (AOT) and Education | Active comparator | Behavioral: Action-observation therapy & Education10 participants will be randomly assigned to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First unilateral stroke (<6-month post-stroke at enrollment)
- ≥18 years old
- Hand sensorimotor impairments
- Able to understand and follow a two-step instruction
- Admitted to the rehabilitation center and participating in the stroke program
Key exclusion criteria (5 listed)
- Severe spasticity (score ≥3 on the Modified Ashworth Scale)
- Unilateral spatial neglect
- Moderate to severe hand pain
- Significant motor impairment of the fingers (active finger flexion/extension less than 10°)
- Any medical condition that may interfere with participation
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 |
|---|---|---|
| robotic-assisted hand therapyAlso: hand exosqueleton coupled with a virtual reality programParticipants will receive the GRIP program in addition to usual rehabilitation care. The program uses a soft robotic glove worn on the affected hand together with a non-immersive virtual-reality system that displays hand exercises and a virtual hand that moves with the participant's real movements. The glove can provide assistance or resistance to support grasping practice and strengthening. Training focuses on repeated grasping tasks and strategies to increase use of the affected hand in daily activities. The program includes ten supervised 30-minute sessions over two weeks. | Device | Glove for Rehabilitation and Interactive Practice (GRIP) program |
| Action-observation therapy & EducationAlso: Education, Action-Observation TherapyParticipants will receive usual rehabilitation care plus action-observation therapy (AOT). They will complete ten self-directed 30-minute AOT sessions over two weeks. Each session consists of repeated cycles of watching short videos of hand movements and then attempting to reproduce those movements with the affected hand. Videos will match the grasp types practiced in the intervention arm. Participants will also attend three individual education sessions on post-stroke arm and hand recovery, including strategies to increase use of the affected hand in daily activities. | Behavioural | Action-Observation Therapy (AOT) and Education |
Primary outcome
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time frame: At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)
It is a stroke-specific, performance-based impairment index designed to measure upper extremity motor recovery after stroke.
1 secondary outcome
Action Research Arm Test
Time frame: At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Johanne Higgins, PhD study director
Université de Montréal, CRIR
Marika Demers, PhD study director
Université de Montréal, CRIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic-assisted hand therapy and Action-observation therapy & Education in people with Stroke, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal 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 5 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: opening soon, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanne Higgins, PhD (514 343-6111 ext. 29924, johanne.higgins@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment Upper Extremity (FMA-UE) (time frame: At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.