Pilot Trial of Robotic Hand Therapy After Stroke
9 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
20
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Johanne Higgins, PhD
- Telefoonnummer: 29924 514 343-6111
- E-mail: johanne.higgins@umontreal.ca
Studie Contact Back-up
- Naam: Marika Demers, PhD
- Telefoonnummer: 30897 514 343-6111
- E-mail: marika.demers@umontreal.ca
Studie Locaties
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Quebec
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Montreal, Quebec, Canada, H3S 2J4
- Institut de réadaptation Gingras-Lindsay-de-Montréal
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Contact:
- Johanne Higgins, PhD
- Telefoonnummer: 29924 514 343-6111
- E-mail: johanne.higgins@umontreal.ca
-
Contact:
- Marika Demers, PhD
- Telefoonnummer: 30897 514 343-6111
- E-mail: marika.demers@umontreal.ca
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Onderonderzoeker:
- Katherine Samuel, Master's degree
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Hoofdonderzoeker:
- Marika Demers, PhD
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Hoofdonderzoeker:
- Johanne Higgins, PhD
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Glove for Rehabilitation and Interactive Practice (GRIP) program
10 participants will be randomly assigned to this group.
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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.
Andere namen:
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Actieve vergelijker: Action-Observation Therapy (AOT) and Education
10 participants will be randomly assigned to this group.
|
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Tijdsspanne: 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.
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At enrollment , post-intervention (at 2 weeks), and 1 month follow-up (at 6 weeks)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Action Research Arm Test
Tijdsspanne: 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)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Box and Blocks
Tijdsspanne: 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)
|
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Nine-Hole Peg Test
Tijdsspanne: At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
|
Fine manual dexterity
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At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
|
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ABILHAND questionnaire
Tijdsspanne: 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.
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At enrollment, post-intervention (at 2 weeks), 1 month follow-up (at 6 weeks)
|
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Hand dynamometer
Tijdsspanne: 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)
|
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Pinch gauge
Tijdsspanne: 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)
|
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Semi-structured interview with the GRIP group
Tijdsspanne: Post-intervention (at 2 weeks).
|
A qualitative semi-structured interview on the satisfaction with the intervention, perceived benefits, tolerance and engagement
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Post-intervention (at 2 weeks).
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie directeur: Johanne Higgins, PhD, Université de Montréal, CRIR
- Studie directeur: Marika Demers, PhD, Université de Montréal, CRIR
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
1 juli 2027
Studie voltooiing (Geschat)
1 juli 2027
Studieregistratiedata
Eerst ingediend
9 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 juli 2026
Eerst geplaatst (Werkelijk)
16 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
9 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-2490
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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