Pilot Trial of Robotic Hand Therapy After Stroke

Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Study ID
NCT07706621
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Glove for Rehabilitation and Interactive Practice (GRIP) program
    10 participants will be randomly assigned to this group.
  • Active Comparator: Action-Observation Therapy (AOT) and Education
    10 participants will be randomly assigned to this group.

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) ]

Central Contacts

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