NCT07760090

Brief Summary

Loss of upper extremity and particularly hand function after stroke reduces independence in daily activities such as eating, dressing, and personal care. Robot-assisted hand rehabilitation provides repetitive, intensive, and task-oriented practice that supports motor learning, dexterity, and functional hand use. Motor imagery, the mental rehearsal of a movement without physically performing it, is thought to activate motor-related brain networks and to support motor learning and neuroplasticity. Evidence on the added value of combining motor imagery with robot-assisted hand rehabilitation for activities of daily living is limited. This randomized controlled trial will investigate whether motor imagery training added to robot-assisted hand rehabilitation produces greater improvement in activities of daily living than robot-assisted hand rehabilitation alone in individuals with stroke. Forty participants will be randomly allocated to an experimental group (robot-assisted hand rehabilitation plus motor imagery, n=20) or a control group (robot-assisted hand rehabilitation alone, n=20). Both groups will receive the same dose of robot-assisted hand rehabilitation with a soft robotic hand rehabilitation glove, three days per week for six weeks. Outcomes will be assessed at baseline and after the six-week program.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable stroke

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

motor imagerymental practicerobot-assisted rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in independence in activities of daily living (Barthel Index)

    The Barthel Index assesses independence in basic activities of daily living including feeding, bathing, grooming, dressing, toilet use, transfers, walking, stair climbing, and bladder and bowel control. Total score ranges from 0 to 100. Higher scores indicate greater independence.

    Baseline and after the six-week intervention program (week 6)

Study Arms (2)

Robot-assisted hand rehabilitation plus motor imagery

EXPERIMENTAL

Participants receive robot-assisted hand rehabilitation with a soft robotic hand rehabilitation glove, three days per week for six weeks, 40 to 60 minutes per session, plus motor imagery training in which they mentally rehearse hand opening and closing, grasping, object holding, and hand movements used in daily life before physically performing them. Verbal guidance is provided when needed.

Other: Robot-assisted hand rehabilitationBehavioral: Motor imagery training

Robot-assisted hand rehabilitation alone

ACTIVE COMPARATOR

Participants receive robot-assisted hand rehabilitation with a soft robotic hand rehabilitation glove at the same frequency, duration, and session length as the experimental group, three days per week for six weeks, 40 to 60 minutes per session, without motor imagery training.

Other: Robot-assisted hand rehabilitation

Interventions

Individual, physiotherapist-supervised robot-assisted hand rehabilitation delivered with a soft robotic hand rehabilitation glove (Syrebo), providing repetitive task-oriented hand opening, closing, and grasping practice. Three sessions per week for six weeks, approximately 40 to 60 minutes per session.

Robot-assisted hand rehabilitation aloneRobot-assisted hand rehabilitation plus motor imagery

Mental rehearsal of hand opening and closing, grasping, object holding, and hand movements used in daily life, performed before the corresponding physical movement, with verbal guidance when needed. Delivered in the same sessions as robot-assisted hand rehabilitation, three days per week for six weeks.

Robot-assisted hand rehabilitation plus motor imagery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 years or older
  • Diagnosis of stroke
  • Impairment of upper extremity function, particularly hand function
  • Modified Ashworth Scale grade of 2 or below in the wrist and finger flexors
  • Hand and finger range of motion sufficient for safe application of the robotic hand rehabilitation glove
  • Attention and cooperation sufficient to participate in motor imagery training

You may not qualify if:

  • Severe cognitive, visual, or hearing impairment
  • Additional neurological or orthopaedic disease affecting the upper extremity
  • Modified Ashworth Scale grade above 2 in the wrist and finger flexors
  • Marked contracture, advanced joint restriction, or pain preventing the intervention
  • Skin problems, open wounds, or infection preventing the use of the robotic hand rehabilitation glove
  • Inability to attend the intervention program regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lambert KJ, Hoar C, Houle J, Motley C, Ball N, Leung AW. Motor imagery as an intervention to improve activities of daily living post-stroke: A systematic review of randomized controlled trials. Br J Occup Ther. 2023 May;86(5):335-348. doi: 10.1177/03080226221145441. Epub 2023 Feb 7.

    PMID: 40336516BACKGROUND
  • Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

    PMID: 30175845BACKGROUND
  • Ietswaart M, Johnston M, Dijkerman HC, Joice S, Scott CL, MacWalter RS, Hamilton SJ. Mental practice with motor imagery in stroke recovery: randomized controlled trial of efficacy. Brain. 2011 May;134(Pt 5):1373-86. doi: 10.1093/brain/awr077. Epub 2011 Apr 22.

    PMID: 21515905BACKGROUND

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seda Kabak

    Üsküdar University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel-group randomized controlled trial with 1:1 allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made publicly available. De-identified data supporting the findings may be made available from the corresponding author on reasonable request, subject to institutional approval.