fNIRS for Monitoring Cortical Activity in Stroke Recovery

NCT07623512 | Recruiting

• 1 other identifier: 202400386B0
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Functional near-infrared spectroscopy (fNIRS)

  Assessments will be conducted at baseline, mid-intervention (during weeks 3-4 of the intervention), immediately after the intervention, and at the 3-month post-trial follow-up.

Study Arms (2)

End-Effector (EE) robot-assisted training group

EXPERIMENTAL

Robot-assisted therapy (EE system) and functional training

Device: Robot-assisted therapy (EE or EXO system) and functional training

Exoskeleton (EXO) robot-assisted training group.

EXPERIMENTAL

Robot-assisted therapy (EXO system) and functional training

Device: Robot-assisted therapy (EE or EXO system) and functional training

Interventions

Robot-assisted therapy (EE or EXO system) and functional training DEVICE

Each group will receive intervention 3 times per week, 60 minutes per session, for a total duration of 6 weeks. The intervention will consist of 40 minutes of robot-assisted therapy and 20 minutes of functional training. For the robot-assisted therapy, participants will receive training using either the EE or EXO system according to group allocation. The functional training component will be conducted without robotic assistance and will focus on task-oriented activities to facilitate the transfer of motor learning to functional performance.

End-Effector (EE) robot-assisted training group; Exoskeleton (EXO) robot-assisted training group.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chieh-ling Yang

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieh_ling Yang

CONTACT

03-2118800; chieh-ling.yang@cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 3, 2026
• Study Start: November 28, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

TW (1)