Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in Trunk Displacement
研究概览
简要总结
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
详细描述
This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second baseline measurement, all subjects will be randomized to upper-extremity rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP) followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance training (Power) followed by FTP. Re-evaluation will occur following each block of treatment,and retention effects will be evaluated after 6 and 12 months with no additional treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical Neurology and Rehabilitation, a battery of biomechanical performance measures including: strength, muscle activation, reflex modulation, and motor coordination, and with kinematics of free reaching movements. The researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of cerebrovascular accident
- •Single event
- •Unilateral hemiplegia
- •Between 6 months and 18 months post-event
- •Impairment of upper-extremity function
- •Ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist
- •At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers
- •Cognitive ability to follow 3-step commands
排除标准
- •Unstable or uncontrolled blood pressure
- •Uncontrolled seizures
- •Flaccid hemiplegia
- •Severe cognitive impairment
结局指标
主要结局
Change in Trunk Displacement
时间窗: baseline, 10 weeks, 20 weeks
Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.
Change in Shoulder Flexion
时间窗: baseline, 10 weeks, 20 weeks
joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.
Upper-extremity Fugl-Meyer Motor Assessment
时间窗: baseline, 10 weeks, 20 weeks
The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.
Change in Elbow Extension Range of Motion
时间窗: baseline, 10 weeks, 20 weeks
joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.
次要结局
- Movement Speed(baseline, 10 weeks, 20 weeks)
- Movement Accuracy (Reach Path Ratio, RPR)(baseline, 10 weeks, 20 weeks)
- Movement Smoothness(baseline, 10 weeks, 20 weeks)