Effects of Robot-Assisted Therapy in Sequential Combination With Constraint-Induced Therapy in Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
The findings of this project will contribute to the understanding of a comprehensive probe for investigation of the effects of monotherapy versus combination rehabilitation intervention after stroke, including the topics of possible underlying mechanisms of motor recovery as well as the beneficial and adverse effects of intense rehabilitation therapy, prognostic factors of the outcomes, and clinimetric properties of the instruments. The overall findings of this project will be significant in the era of knowledge translation and guide the development of innovative and effective interventions for individualized stroke rehabilitation.
详细描述
The overall goal of this research project will be to provide scientific evidence of the robot-assisted therapy in sequential combination with distributed constraint-induced therapy (RT + dCIT)versus monotherapy of the robot-assisted therapy (RT), distributed constraint-induced therapy (dCIT), and a dose-matched control therapy (DMCT)in stroke rehabilitation. The specific aims of this proposed research are identified as follows:
- The investigators will investigate the treatment effects of RT + dCIT compared to RT, CIT, and DMCT on motor ability, muscle function, sensory function, daily performance, real-world arm activity, quality of life, and motor control variables at before treatment, midterm assessment, and after treatment. In addition to study of treatment benefits, physiological responses as the potential adverse effects including post-exertional fatigue, post-exertional pain, and a biomarker of oxidative stress will be also examined in this project. The investigators hypothesized that the therapeutic regimen combining RT with dCIT will contribute to more significantly reduction in impairment and disability for stroke patients than the other intervention groups.
- The investigators will investigate if the clinical characteristics or behavioral markers of stroke patients will influence the outcomes after interventions. The proposed potential predictors will be chronicity, side of lesion, muscle tone, motor ability of distal part of upper limb, and amount of affected hand use.
- The investigators will examine whether the improved scores after each treatment reach clinically important changes in order to establish the clinical significance relevant for individualized medicine. The investigators will also assess and compare the clinimetric properties (e.g., validity, responsiveness, minimal detectable change, and minimal clinically important difference) of the rehabilitation outcomes to inform selection of instruments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 months onset from a first-ever unilateral stroke
- •An initial UL subsection of the Fugl-Meyer Assessment score of 20 to 50 indicating moderate and moderate to severe UL movement impairment
- •No balance problems sufficient to compromise safety when wearing the study's constraint device
- •No excessive spasticity in any of the joints of the affected UL (modified Ashworth scale ≤ 3)
- •Without upper limb fracture within 3 months
- •Be able to follow study instructions and perform study tasks (Mini Mental State Examination ≥ 24)
- •Willing to provide written informed consent
排除标准
- •Exhibit physician-determined major medical problems or poor physical conditions that would interfere with participation
- •Excessive pain in any joint that might limit participation
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: An expected average of 4 weeks
The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery.
次要结局
- Functional Independence Measure (FIM)(An expected average of 4 weeks)
- Stroke Impact Scale Version 3.0 (SIS 3.0)(An expected average of 4 weeks)
- Visual analogue scale (VAS) for assessing post-exertional fatigue and pain(An expected average of 4 weeks)
- Actigraphy(An expected average of 4 weeks)
- Motor Status Score (MSS)(An expected average of 4 weeks)
- Wolf Motor Function Test (WMFT)(An expected average of 4 weeks)
- Medical Research Council scale (MRC)(An expected average of 4 weeks)
- Modified Ashworth Scale (MAS)(An expected average of 4 weeks)
- Revised Nottingham Sensory Assessment (RNSA)(An expected average of 4 weeks)
- Myoton(An expected average of 4 weeks)