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NCT Number: NCT07706621

Pilot Trial of Robotic Hand Therapy After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de réadaptation Gingras-Lindsay-de-Montréal

Montreal, Quebec, H3S 2J4, Canada

Location contact

Johanne Higgins, PhD

CONTACT

[email protected]

514 343-6111 ext. 29924

Johanne Higgins, PhD

PRINCIPAL_INVESTIGATOR

Katherine Samuel, Master's degree

SUB_INVESTIGATOR

Marika Demers, PhD

CONTACT

[email protected]

514 343-6111 ext. 30897

Marika Demers, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: hand exosqueleton coupled with a virtual reality program

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.

Other names: Education, Action-Observation Therapy

Primary outcomes

  1. Fugl-Meyer Assessment Upper Extremity (FMA-UE)

    Time frame: 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 outcomes

  1. Action Research Arm Test

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

    Observational measure that examines upper limb functional recovery

Other outcomes

  1. Box and Blocks

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

    Unilateral gross manual dexterity

  2. Nine-Hole Peg Test

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

    Fine manual dexterity

  3. ABILHAND questionnaire

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

    Semi-structured item-response questionnaire that measures manual ability according to an individual's perceived difficulty performing daily bimanual tasks.

  4. Hand dynamometer

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

    Grip strength measurement

  5. Pinch gauge

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

    To measure 2-finger pinch, 3-finger pinch and lateral pinch

  6. Semi-structured interview with the GRIP group

    Time frame: Post-intervention (at 2 weeks).

    A qualitative semi-structured interview on the satisfaction with the intervention, perceived benefits, tolerance and engagement

Study contacts

Contact information is provided by the study sponsor or research team.

Johanne Higgins, PhD

CONTACT

[email protected]

514 343-6111 ext. 29924

Marika Demers, PhD

CONTACT

[email protected]

514 343-6111 ext. 30897

Sponsors and collaborators

Lead sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Other

Collaborators

  • National Research Council, Canada

Registry information

Official study title

Robotic-Assisted Hand Therapy for Neurorehabilitation in Adults With Hand Sensorimotor Impairments Following a Stroke: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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