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| Name | Class |
|---|---|
| National Research Council, Canada | UNKNOWN |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glove for Rehabilitation and Interactive Practice (GRIP) program | Experimental | 10 participants will be randomly assigned to this group. |
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| Action-Observation Therapy (AOT) and Education | Active Comparator | 10 participants will be randomly assigned to this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robotic-assisted hand therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test | Observational measure that examines upper limb functional recovery | At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Blocks | Unilateral gross manual dexterity | At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks) |
| Nine-Hole Peg Test | Fine manual dexterity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanne Higgins, PhD | Contact | 514 343-6111 | 29924 | johanne.higgins@umontreal.ca |
| Marika Demers, PhD | Contact | 514 343-6111 | 30897 | marika.demers@umontreal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Johanne Higgins, PhD | Université de Montréal, CRIR | Study Director |
| Marika Demers, PhD | Université de Montréal, CRIR | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de réadaptation Gingras-Lindsay-de-Montréal | Montreal | Quebec | H3S 2J4 | Canada |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Action-observation therapy & Education | Behavioral | 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. |
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| At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks) |
| ABILHAND questionnaire | Semi-structured item-response questionnaire that measures manual ability according to an individual's perceived difficulty performing daily bimanual tasks. | At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks) |
| Hand dynamometer | Grip strength measurement | At enrollment, post-intervention (at 2 weeks), 1 month follow up (at 6 weeks) |
| Pinch gauge | To measure 2-finger pinch, 3-finger pinch and lateral pinch | At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks) |
| Semi-structured interview with the GRIP group | A qualitative semi-structured interview on the satisfaction with the intervention, perceived benefits, tolerance and engagement | Post-intervention (at 2 weeks). |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |