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NCT Number: NCT07623512

fNIRS for Monitoring Cortical Activity in Stroke Recovery

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location status: Recruiting

Location contact

Chieh-ling Yang

CONTACT

[email protected]

03-2118800 ext. 3058

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Task-related changes in oxyhemoglobin (HbO) concentration measured using 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.

    Cortical activation will be quantified as task-related changes in oxyhemoglobin (HbO) measured using functional near-infrared spectroscopy (fNIRS) during robot-assisted movements and upper extremity functional tasks (e.g., shoulder abduction, finger extension, and grasping).

Study contacts

Contact information is provided by the study sponsor or research team.

Chieh_ling Yang

CONTACT

[email protected]

03-2118800 ext. 3058

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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