NCT07623512 fNIRS for Monitoring Cortical Activity in Stroke Recovery
| NCT ID | NCT07623512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2025-11-28 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial aims to investigate the mechanisms of brain reorganization underlying motor recovery following end-effector (EE) and exoskeleton (Exo) robot-assisted hand training in individuals with stroke. Using functional near-infrared spectroscopy (fNIRS), the study will (1) investigate brain activation patterns during EE and Exo robot-assisted hand movements in healthy adults and individuals with stroke and (2) examine longitudinal changes in brain activation and motor recovery over a 6-week intervention. For Part 1, a cross-sectional observational study will be conducted to examine brain activation using fNIRS while participants perform EE and Exo robot-assisted movements. Healthy adults and individuals with stroke will each perform one session of each type of robot-assisted movement. For Part 2, an evaluator-blinded randomized controlled design will be used. Participants will be stratified based on the level of motor impairment and the side of the brain lesion and then randomly assigned to either the EE or Exo robot-assisted training group. Both groups will receive training 3 times per week, with each session lasting 60 minutes, for a total of 6 weeks. Each session will include 40 minutes of robot-assisted therapy and 20 minutes of functional training. Outcome assessments will be conducted at four time points: prior to the intervention (baseline), mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up. These assessments will be used to evaluate motor recovery and longitudinal changes in brain function.
Eligibility 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
Contact & Investigator
Chieh-ling Yang
PRINCIPAL INVESTIGATOR
Chang Gung University
Frequently Asked Questions
Who can join the NCT07623512 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07623512 currently recruiting?
Yes, NCT07623512 is actively recruiting participants. Contact the research team at chieh-ling.yang@cgu.edu.tw for enrollment information.
Where is the NCT07623512 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT07623512 clinical trial?
NCT07623512 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Chieh-ling Yang at Chang Gung University. The trial plans to enroll 108 participants.
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