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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Contact Information
Primary
Chieh_ling Yang
chieh-ling.yang@cgu.edu.tw
03-2118800
Time Frame
Start Date: 2025-11-28
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 108
Treatments
Experimental: End-Effector (EE) robot-assisted training group
Robot-assisted therapy (EE system) and functional training
Experimental: Exoskeleton (EXO) robot-assisted training group.
Robot-assisted therapy (EXO system) and functional training
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov