Comparative Hybrid Effects of Combining Botulinum Toxin Type A With Robot-assisted Training v.s. With Mirror Therapy for Stroke Patients With Upper Extremity Spasticity: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Motor function assessed on Fugl-Meyer Assessment (FMA)
研究概览
简要总结
The aim of this study will be to determine and compare the immediate and longer-term effects of combination of BoNT-A injection and mirror therapy vs combination of BoNT-A injection and robot-assisted therapy.
详细描述
The purpose of this project is to examine and compare the immediate and long-term effects of combined Botulinum toxin type A injection with mirror therapy (MT) and with bilateral robot-assisted (RT) in patients with spastic hemiplegic stroke. Spasticity, a common impairment after stroke, has a profound impact on activity and participation for patients. BoNT-A injection combined with rehabilitation training is recommended to enhance functional recovery for stroke patients with spasticity. Although the positive combination effects of BoNT-A with stretch, RT, and constraint-induced movement therapy were reported, the quality of the evidence was weak due to methodology limitations. In addition, patients with spasticity usually have lower motor function and worse sensory deficits than patients without spasticity. Designing the post BoNT-A injection rehabilitation program should consider the above issues. RT and MT are two interventions providing sensorimotor input for patient with low level of motor function. It is unknown whether combining BoNT-A injection with RT or with MT have positive effects and engenders differential effects on motor and related functional performance.
At least 60 participants with chronic spastic hemiplegic stroke will be recruited and randomly assigned to one of 3 groups: BoNT-A injection with RT, BoNT-A injection with MT, and BoNT-A injection with control intervention (CI). All the post-injection interventions will be implemented 60 minutes/day, 3 days/week, for 8 weeks. The RT group will receive 30-minute RT, followed by 30-minute functional training. The MT group will receive 30-minute MT, followed by 30-minute functional training. The CI group will receive 60-minute rehabilitation program, such as bilateral arm training and functional task practice. Body function and structures outcome measures include Fugl-Meyer Assessment, Modified Ashworth Scale, Medical Research Council scale, myometer (Myoton-3), actigraph, and Pittsburgh Sleep Quality Index. Activity and participation measures include Wolf Motor Function Test, Ten meter walk test, Motor Activity Log, Nottingham Extended Activities of Daily Living Scale, and Canadian Occupational Performance Measure. In addition, to directly reflect a patient's unique needs and goals, Goal Attainment Scaling will be assessed. Evaluators will be blind to group allocation. The outcome will be measured at pre-treatment, post-treatment, and 3-month follow-up.
This comparative efficacy study will be the first to examine and compare the immediate and long-term combination effects of BoNT injection with RT, MT, or CI. The follow-up assessments will provide the long-term effects of different treatments on health-related outcomes, which are crucial for community reentry. In addition, the results of objective assessments and patient-reported outcomes may lead to individualized upper limb training following BoNT-A injection for patients with spastic hemiplegic stroke.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to provide written informed consent
- •Clinical and imagine diagnosis of a first or recurrent unilateral stroke ≥ 3 months
- •Upper limb spasticity (Modified Ashworth scale of ≥ 2)
- •Moderate to severe movement impairment of U/E (FMA score ranging from 18 to 56)
- •No serious cognitive impairment (i.e., Mini Mental State Exam score > 18)
- •Age ≥ 18 years
排除标准
- •Bilateral hemispheric or cerebellar lesions
- •Significant visual field deficits or hemineglect
- •Contraindication for BoNT-A injection
研究组 & 干预措施
Robot-assisted therapy (RT)
After injection with Botulinum Toxin Type A, a schedule of robot-assisted therapy appointments will be established. Each intervention includes 45 minutes of robotic training and 30 minutes of training in functional activities.
干预措施: Botulinum Toxin Type A (Drug)
Robot-assisted therapy (RT)
After injection with Botulinum Toxin Type A, a schedule of robot-assisted therapy appointments will be established. Each intervention includes 45 minutes of robotic training and 30 minutes of training in functional activities.
干预措施: Robot-assisted therapy (Other)
Mirror therapy (MT)
After injection with Botulinum Toxin Type A, a schedule of mirror therapy appointments will be established.The MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training.
干预措施: Botulinum Toxin Type A (Drug)
Mirror therapy (MT)
After injection with Botulinum Toxin Type A, a schedule of mirror therapy appointments will be established.The MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training.
干预措施: Mirror therapy (Other)
Control Intervention (CI)
After injection with Botulinum Toxin Type A, a schedule of control intervention appointments will be established.The CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.
干预措施: Botulinum Toxin Type A (Drug)
Control Intervention (CI)
After injection with Botulinum Toxin Type A, a schedule of control intervention appointments will be established.The CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.
干预措施: Control intervention (Other)
结局指标
主要结局
Motor function assessed on Fugl-Meyer Assessment (FMA)
时间窗: Change from baseline at 5 months
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
次要结局
- Muscle power assessed on Medical Research Council Scale (MRC)(Change from baseline at 5 months)
- The participants' individual goals assessed on Goal attainment scale (GAS)(Change from baseline at 5 months)
- The quality of sleep assessed on Pittsburgh Sleep Quality Index (PSQI)(Change from baseline at 5 months)
- Walking speed assessed on Ten Meter Walk Test (10MWT)(Change from baseline at 2 months)
- The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)(Change from baseline at 5 months)
- The quality of movement and amount of use assessed on Motor Activity Log (MAL)(Change from baseline at 5 months)
- The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)(Change from baseline at 5 months)
- The participant's perception of the performance assessed on Canadian Occupational Performance Measure (COPM)(Change from baseline at 2 months)
- Revised Notttingham Sensory Assessment (RNSA)(Change from baseline at 2 months)
- Muscle tone assessed on Modified Ashworth Scale (MAS)(Change from baseline at 5 months)
- The functional state assessed on Myometer Assessment(Change from baseline at 5 months)
- The amount of movement assessed on Actigraph Assessment(Change from baseline at 2 months)
- Stroke Impact Scale (SIS)(Change from baseline at 5 months)