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临床试验/NCT07623512
NCT07623512招募中不适用

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

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
108
试验地点
1
主要终点
Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Exoskeleton (EXO) robot-assisted training group.

Experimental

Robot-assisted therapy (EXO system) and functional training

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

End-Effector (EE) robot-assisted training group

Experimental

Robot-assisted therapy (EE system) and functional training

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

结局指标

主要结局

Task-related changes in oxyhemoglobin (HbO) concentration measured using functional near-infrared spectroscopy (fNIRS)

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chieh-ling Yang

Associate Professor

Chang Gung Memorial Hospital

研究点 (1)

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