Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,047
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Upper Extremity Scale
研究概览
简要总结
This study aims to investigate the effects of motor-cognitive interactive robot-assisted training on improving upper limb motor dysfunction after stroke. By observing different combinations of motor and cognitive components in the training, the study will clarify the relationship between the proportion of motor and cognitive elements and the recovery of upper limb motor function. The goal is to optimize the training protocol for upper limb rehabilitation robots and enhance their therapeutic outcomes.
Participants will be randomly assigned to one of three groups: motor-cognitive interactive robot-assisted training, motor-focused robot-assisted training, or conventional rehabilitation training. Training sessions will last 60 minutes, occur 5 times per week, and continue for 4 weeks. Researchers will measure changes in upper limb function and monitor for any adverse events during the training.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke confirmed by CT or MRI.
- •Age between 40 and 80 years, with no gender restrictions.
- •First-ever stroke with unilateral limb paralysis.
- •Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-
- •Willingness to participate and provide written informed consent.
排除标准
- •History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases.
- •Seated balance score < 2, or inability to maintain a sitting position for more than 60 minutes.
- •Modified Ashworth Scale score >
- •Visual Analog Scale (VAS) score > 3 for hemiplegic shoulder pain.
- •Boston Diagnostic Aphasia Examination score <
- •Severe visual impairment preventing participation in upper limb robot-assisted rehabilitation training.
- •Hamilton Depression Scale score >17, indicating moderate to severe depressive symptoms.
- •Participation in other clinical trials that may interfere with the results of this study.
研究组 & 干预措施
Motor-cognitive interactive robot-assisted training
干预措施: Motor-cognitive interactive robot (Device)
Motor-focused robot-assisted training
干预措施: Motor-focused robot (Device)
Conventional rehabilitation training
干预措施: Conventional rehabilitation training (Behavioral)
结局指标
主要结局
Fugl-Meyer Upper Extremity Scale
时间窗: 4 weeks (post-intervention)
Score range 0-66, higher scores indicate better upper limb motor recovery.
次要结局
- Fugl-Meyer Upper Extremity Scale(3 months (post-intervention follow-up))
- Upper limb kinematics during standardized 3D grid tasks(4 weeks)
- Upper Limb Muscle Strength Assessment(4 weeks, 3 months)
- Modified Barthel Index(4 weeks, 3 months)
- Montreal Cognitive Assessment(4 weeks, 3 months)
- Auditory Verbal Learning Test(4 weeks, 3 months)
- Trail Making Test Part A(4 weeks, 3 months)
- Trail Making Test Part B(4 weeks, 3 months)
- Stroke-Specific Quality of Life Scale(4 weeks, 3 months)
研究者
Lidian Chen
Professor
Fujian University of Traditional Chinese Medicine