fNIRS for Monitoring Cortical Activity in Stroke Recovery

May 28, 2026 updated by: Chieh-ling Yang, Chang Gung Memorial Hospital

Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: End-Effector (EE) robot-assisted training group
Robot-assisted therapy (EE system) and functional training
Device: Robot-assisted therapy (EE or EXO system) and functional training
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.
Experimental: Exoskeleton (EXO) robot-assisted training group.
Robot-assisted therapy (EXO system) and functional training
Device: Robot-assisted therapy (EE or EXO system) and functional training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional near-infrared spectroscopy (fNIRS)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chieh-ling Yang, Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202400386B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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