Effects of Robotic Modified Constraint -Induced Therapy on Behavioral Outcomes and Motor-learning Process in Patients With Spastic Hemiplegic Stroke Post Botulinum Toxin Type A Injection: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
Background and purpose: Botulinum toxin A (BoNT-A) injection is effective in reducing spasticity. However, the optimal training program post BoNT-A injection remains uncertain. Constraint-induced movement therapy (CIMT) is the most investigated intervention with promising effects for improving upper extremity (UE) function and increasing use frequency of the affected limb in ADL. The CIMT has strict inclusion criteria, which might not be suitable for a majority of patients who have moderate to severe spasticity. The aims of this study are to compare the effect of Robotic mCIMT with conventional upper extremity rehabilitation training in patient with spastic hemiplegia post BoNT-A injection.
Methods: Those patients with spastic hemiplegic stroke will receive BoNT-A injection and then be randomly assigned to either Robotic mCIMT group (1 hour unilateral robotic therapy, followed by 30 minutes of functional practice of affected UE using shaping technique, 3/week for 8 weeks and restraint of the unaffected limb at home for 2 hrs per day ) or control group (conventional upper extremity rehabilitation training 1.5 hours per session, 3/week for 8 weeks and home exercise 2 hrs per day).
Body function and structures outcome measures, such as Fugl-Meyer Assessment, Actigraph ; activity and participation measures, such as Wolf Motor Function Test, Motor Activity Log, will be assessed before, after intervention, and 3 months post-intervention. Investigators will also monitor the kinematic data of InMotion 3.0 robot across the whole course of Robotic mCIMT to see how the Robotic mCIMT following BoNT-A injection impacts motor learning process of the participants.
Analysis: To evaluate the treatment effects of the outcome measures, 2 groups (Robotic mCIMT or control) * 3 times (before intervention, after intervention, and 3 months after intervention) repeated-measure ANOVA will be used.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months; (2) upper limb spasticity (modified Ashworth scale of ≥ 1+ for elbow flexor and/or forearm pronator and/or finger flexor muscles and/or wrist flexor muscles (Bohannon & Smith, 1987); (3) initial motor part of UE of FMA score ranging from 17 to 56, indicating moderate to severe movement impairment (Duncan, Goldstein, Matchar, Divine, & Feussner, 1992; Fugl Meyer, Jaasko, & Leyman, 1975; Park, Wolf, Blanton, Winstein, & Nichols-Larsen, 2008); (4) no serious cognitive impairment (i.e., Mini Mental State Exam score > 20) (Teng & Chui, 1987); (5) age ≥ 20 years ; and (6) willing to provide written informed consent.
排除标准
- •1. pregnant
- •with bilateral hemispheric or cerebellar lesions
- •sever aphasia
- •significant visual field deficits or hemineglect
- •contraindication for BoNT-A injection
- •treatment with BoNT-A within 4 months before recruitment
- •any fixed joint contracture of the affected upper limb
- •a history of orthopedic or other neurological diseases and/or medical conditions that would prevent adherence to the rehabilitation protocol.
结局指标
主要结局
Modified Ashworth Scale
时间窗: Change from baseline at 1.5 months
Spasticity of skeletal muscle in upper extremity will be evaluated by using the MAS scale (Bohannon \& Smith, 1987).It uses a 6-point scale to score the average resistance to passive movement for each join with higher score indicating higher spasticity. The MAS has shown good reliability and validity (Pandyan et al., 1999).
Actigraph
时间窗: Change from baseline at 1.5 months
The amount of the impaired arm movement will be assessed by the activity monitors (i.e. accelerometers)(Schasfort, Busmann, Martens, \& Stam, 2006; Uswatte, Giuliani, et al., 2006; Uswatte et al., 2000). Accelerometers, objectively recording the amount of activity in free-living conditions and estimating energy expenditure, have been applied to measure the amount of affected arm use over time. In addition, accelerometers were also used to provide a measure of sleep latency and efficiency in this project. The participants were required to comply with wearing the accelerometer on each arm for 3 consecutive days. The accelerometers used in this project will be wireless plastic units about the size and weight of a large wrist watch. The participants will wear them proximal to the wrist on terrycloth bands. The compliance of wearing accelerometers was approximately 76% of waking time (Schasfort et al., 2006).
Wolf Motor Function Test (WMFT)
时间窗: Change from baseline at 1.5 months
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks (Uswatte, Taub, Stuss, Winocur, \& Robertson, 1999). The WMFT includes 17 tasks (15 function-based and 2 strength-based). Performances were timed and rated by using a 6-point ordinal scale. The WMFT has good interrater reliability and criterion validity in patients with UE hemiparesis (D. M. Morris, Uswatte, Crago, Cook, \& Taub, 2001) .
Fugl-Meyer Assessment (FMA)
时间窗: Change from baseline at 1.5 months
The upper-extremity (UE) subscale of the FMA will be used to assess neuromusculoskeletal and movement related functions. It consists of 33 upper extremity items for the reflexes and movement of 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)(Fugl Meyer et al., 1975). Higher score indicates better motor function of UE, and the maximum score is 66. Satisfactory psychometric properties of the FMA have been demonstrated(Platz et al., 2005)
次要结局
- Goal attainment scale (GAS)(Change from baseline at 1.5 months)
- Motor Activity Log (MAL)(Change from baseline at 1.5 months)
- Nottingham Extended Activities of Daily Living Scale (NEADL)(Change from baseline at 1.5 months)