fNIRS study of brain activity during robot-assisted hand therapy after stroke
Official title: Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke
Run by Chang Gung Memorial Hospital · NCT07623512 · Data updated 2026-11-12
This study tests how brain activity changes during end-effector and exoskeleton robot-assisted hand movements in people who had a stroke, to see if therapy supports motor recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Status | Recruiting |
| Started | November 28, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07623512 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with unilateral stroke at least 3 months prior and meeting FMA-UE 18–56, with manageable spasticity and adequate instruction-following ability.
✕Probably not a fit
Patients with uncontrolled medical conditions, severe spasticity, orthopedic or other neurological issues affecting the arm, or recent Botulinum toxin treatment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study uses functional near-infrared spectroscopy (fNIRS) to observe brain activation during two types of robot-assisted hand movements. Part 1 compares brain patterns in healthy adults and stroke patients in a cross-sectional session with each robot type. Part 2 uses an evaluator-blinded randomized design to examine longitudinal changes in brain activity and motor recovery over six weeks, with participants stratified by impairment and lesion side. Interventions include robotic hand therapy (EE or Exo) and functional training, conducted at Chang Gung Memorial Hospital.
Why it matters
Potential benefit: If successful, the approach could improve understanding of how robot-assisted hand therapy influences brain reorganization and motor recovery after stroke.
How similar studies have gone: Previous work suggests functional brain changes can accompany robot-assisted motor training, but this study adds longitudinal fNIRS data in stroke patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Stroke participants Inclusion Criteria: * unilateral stroke onset ≥ 3 months * Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56 - modified Ashworth scale ≤ 3 in proximal joints and modified Ashworth scale ≤ 2 in distal joints * able to follow 2-step instructions * without excessive spasticity in any of the UE joints. Exclusion Criteria: * orthopedic conditions affecting the arm/hand or other neurological conditions * severe pain that prevents movement in the affected arm and hand * implanted cardiac pacemakers and cardioverter-defibrillators * osteoporosis, fracture, or severe ataxia * unstable medical status * participating in other rehabilitation or drug studies simultaneously * receiving Botulinum toxin injections within 3 months Healthy participants * have no neurological conditions * have no musculoskeletal disorders affecting the UE
Where it's running
-
Chang Gung Memorial Hospital
Taoyuan, Taiwan Recruiting
Study contacts
- Principal investigator: Chieh-ling Yang — Chang Gung University
- Study coordinator: Chieh_ling Yang
- Email: chieh-ling.yang@cgu.edu.tw
- Phone: 03-2118800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.