Stroke
Conditions
Keywords
stroke, cerebrovascular accident, virtual reality, virtual environment, robotics, exosqueleton, finger, hand, grasp, manual dexterity, prehension, upper limb, motor recovery, subacute
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.
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.
Interventions
DEVICErobotic-assisted hand therapy
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.
BEHAVIORALAction-observation therapy & Education
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.
Sponsors
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
National Research Council, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment Upper Extremity (FMA-UE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks) | Observational measure that examines upper limb functional recovery |
Countries
Canada
Contacts
CONTACTJohanne Higgins, PhD
CONTACTMarika Demers, PhD
STUDY_DIRECTORJohanne Higgins, PhD
Université de Montréal, CRIR
STUDY_DIRECTORMarika Demers, PhD
Université de Montréal, CRIR
Outcome results
None listed