Pilot Trial of Robotic Hand Therapy After Stroke
Robotic-Assisted Hand Therapy for Neurorehabilitation in Adults With Hand Sensorimotor Impairments Following a Stroke: A Pilot Randomized Controlled Trial
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2026
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2026
CompletedFirst Posted
Study publicly available on registry
July 16, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
July 16, 2026
July 1, 2026
11 months
July 9, 2026
July 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
Action Research Arm Test
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Other Outcomes (6)
Box and Blocks
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Nine-Hole Peg Test
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
ABILHAND questionnaire
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
- +3 more other outcomes
Study Arms (2)
Glove for Rehabilitation and Interactive Practice (GRIP) program
EXPERIMENTAL10 participants will be randomly assigned to this group.
Action-Observation Therapy (AOT) and Education
ACTIVE COMPARATOR10 participants will be randomly assigned to this group.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de réadaptation Gingras-Lindsay-de-Montréal
Montreal, Quebec, H3S 2J4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johanne Higgins, PhD
Université de Montréal, CRIR
- STUDY DIRECTOR
Marika Demers, PhD
Université de Montréal, CRIR
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher and Professor (School of rehabilitation, Université de Montréal)
Study Record Dates
First Submitted
July 9, 2026
First Posted
July 16, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
July 16, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share