Pilot Trial of Robotic Hand Therapy After Stroke

ConditionStroke

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCentre for Interdisciplinary Research in Rehabilitation of Greater Montreal

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

First unilateral stroke (<6-month post-stroke at enrollment)

≥18 years old

Hand sensorimotor impairments

Able to understand and follow a two-step instruction

Disqualifiers

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°)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Glove for Rehabilitation and Interactive Practice (GRIP) programExperimental treatment 1 intervention

Group B: Action-Observation Therapy (AOT) and EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)

Secondary outcomes

Action Research Arm Test

Observational measure that examines upper limb functional recovery

Time frame

At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)

Other outcomes

Box and Blocks

Unilateral gross manual dexterity

Time frame

At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)

Nine-Hole Peg Test

Fine manual dexterity

Time frame

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.

Time frame

At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)

Hand dynamometer

Grip strength measurement

Time frame

At enrollment, post-intervention (at 2 weeks), 1 month follow up (at 6 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Lead sponsor

Université de Montréal

Sponsor institution

National Research Council, Canada

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: