NCT07623512Recruiting
fNIRS for Monitoring Cortical Activity in Stroke Recovery
Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 21 May 2026
- Start date
- 28 Nov 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Stroke
- NCT number
- NCT07623512
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 28 Nov 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- participating in other rehabilitation or drug studies simultaneously
- receiving Botulinum toxin injections within 3 months
- Healthy participants
Other illness
- orthopedic conditions affecting the arm/hand or other neurological conditions
- implanted cardiac pacemakers and cardioverter-defibrillators
- have no neurological conditions
- have no musculoskeletal disorders affecting the UE
Other
- severe pain that prevents movement in the affected arm and hand
- osteoporosis, fracture, or severe ataxia
- unstable medical status
Who the study is looking for
- 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.
Criteria the registry did not label
- Stroke participants
Age in the registry: 20 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.