Functional Near-infrared Spectroscopy (fNIRS) is an Ideal Tool to Monitor Cortical Brain Activity and Understand the Mechanism Underlying Recovery Following Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Exoskeleton (EXO) robot-assisted training group.
Robot-assisted therapy (EXO system) and functional training
Intervention: Robot-assisted therapy (EE or EXO system) and functional training (Device)
End-Effector (EE) robot-assisted training group
Robot-assisted therapy (EE system) and functional training
Intervention: Robot-assisted therapy (EE or EXO system) and functional training (Device)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Chieh-ling Yang
Associate Professor
Chang Gung Memorial Hospital