fNIRS for Monitoring Cortical Activity in Stroke Recovery

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID: NCT07623512
Run by: Chang Gung Memorial Hospital
People needed: 108
Starts: 2025-11-28
Expected to finish: 2028-12-31
Last updated by the study team: 2026-06-16

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Chang Gung Memorial Hospital — Taoyuan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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