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Pilot Trial of Robotic Hand Therapy After Stroke

9. juli 2026 opdateret af: Johanne Higgins, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3S 2J4
        • Institut de réadaptation Gingras-Lindsay-de-Montréal
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Katherine Samuel, Master's degree
        • Ledende efterforsker:
          • Marika Demers, PhD
        • Ledende efterforsker:
          • Johanne Higgins, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Glove for Rehabilitation and Interactive Practice (GRIP) program
10 participants will be randomly assigned to this group.
Enhed: robotic-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.
Andre navne:
  • hand exosqueleton coupled with a virtual reality program
Aktiv komparator: Action-Observation Therapy (AOT) and Education
10 participants will be randomly assigned to this group.
Adfærdsmæssigt: Action-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.
Andre navne:
  • Uddannelse
  • Action-Observation Therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Tidsramme: 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.
At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Action Research Arm Test
Tidsramme: At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Observational measure that examines upper limb functional recovery
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Box and Blocks
Tidsramme: At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Unilateral gross manual dexterity
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Nine-Hole Peg Test
Tidsramme: At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Fine manual dexterity
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
ABILHAND questionnaire
Tidsramme: 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.
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Hand dynamometer
Tidsramme: At enrollment, post-intervention (at 2 weeks), 1 month follow up (at 6 weeks)
Grip strength measurement
At enrollment, post-intervention (at 2 weeks), 1 month follow up (at 6 weeks)
Pinch gauge
Tidsramme: 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
At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
Semi-structured interview with the GRIP group
Tidsramme: Post-intervention (at 2 weeks).
A qualitative semi-structured interview on the satisfaction with the intervention, perceived benefits, tolerance and engagement
Post-intervention (at 2 weeks).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Samarbejdspartnere

National Research Council, Canada

Efterforskere

  • Studieleder: Johanne Higgins, PhD, Université de Montréal, CRIR
  • Studieleder: Marika Demers, PhD, Université de Montréal, CRIR

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

9. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-2490

Plan for individuelle deltagerdata (IPD)

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