The Clinical Effect and Sonographic Findings of Kinesiotaping and Constraint Induced Movement Therapy in Upper Extremity Function and Spasticity in Patients With Subacute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- the change from baseline to time of Fugl-Meyer assessment
研究概览
简要总结
In stroke patients, the most common neurological deficits were motor impairment, loss of somatosensation, abnormal muscle tone, and impaired fractionated movement at affected limbs. Therefore, the investigators try to facilitate upper extremity function and normalize the muscle tone to enlarge their capacity to perform daily activities and to improve life quality by modified constraint-induced movement therapy (mCIMT) and Kinesiotaping (KT).
The investigators will collect 90 subacute stroke patients with hemiplegia in this study. These 90 patients will be randomly divided into 3 groups. In KT group (n=30), the patients will perform Kinesiology taping for 5 days per week for 3 weeks. In mCIMT group (n=30), the patient will receive constraint the unaffected limb for 2 hours a day, 5 days a week for three weeks. In KT+mCIMT group, the KT and mCIMT interventions would be performed for 5 days a week in three weeks. All the patients in KT, CIMT and KT+mCIMT groups will receive 20-minute hand function training twice daily for 5 days per week for 3 weeks. Before intervention, immediately and 3 week later after intervention, all patients will receive the physical examinations including motor recovery stage (Brunnstrom stage), spasticity (modified Ashworth scale and Tardieu scale), and sensation. Fugl-Meyer assessment for upper extremity (FMA-UE), box and block test, Simple Test for Evaluating Hand Function (STEF), and Wolf Motor Function Test for hand function, ADL and quality of life assessment and musculoskeletal sonography for affected forearms will be also evaluated in this study.
The aims of this study are:
- To investigate the effect of Kinesiotaping and modified CIMT in improving upper extremity function and spasticity for subacute stroke patients with hemiplegia.
- To explore the role of sonoelastography and shear wave velocity in poststroke spasticity assessment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients have a stroke with hemiplegia (duration is 3~12 months after stroke).
- •Patients who are able to perform hand grasp.
- •Patients who could slightly do fingers extension and minimal wrist extension. (ability of extension at least 10 degrees at the metacarpophalangeal and interphalangeal joints and 20 degrees at the wrist.)
排除标准
- •age is younger than 18 years or older than 80 years
- •previous history of upper extremity tendon or neuromuscular injury
- •any other systemic neuromuscular disease
- •cognition or language impairment leading to communication difficulty
- •allergy history when application of KT materials
结局指标
主要结局
the change from baseline to time of Fugl-Meyer assessment
时间窗: 3rd week, and 6th week
a therapist will evaluate Fugl-Meyer assessment for upper extremity (FMA-UE) for each participant. In this assessment, participants would need to execute a series of movements, which involved proximal and distal part of upper limb. The higher the grade, the better the performance.
the change from baseline to time of Musculoskeletal sonography
时间窗: 3rd week, and 6th week
an experienced physiatrist will evaluate the findings on sonography, sonoelastography, and shear wave velocity (SWV). The participants will sit upright and put their upper extremities on the bed with elbow flexion in 90 degrees and the forearm full supination. The measured levels for evaluating FCR, FCU, and FDS muscles will be recorded at first time and use the same level at follow up for each patient. The SWV will be done in the longitudinal/transverse planes and be performed at the maximal cross-section area of the muscles and repeatedly measured for 7 times for each muscle. The sonoelastography will be applied in the longitudinal plane of the detected muscles at the same level of the SWV.
the change from baseline to time of MAS scale
时间窗: 3rd week, and 6th week
a therapist will measure spasticity of affected upper extremity at elbow and wrist joints (modified Ashworth scale). In this scale, muscle tone would be assessed by quick stretch of muscle belly. The scoring criteria are as follows. 0, no increase in muscle tone; 1, Slight increase in muscle tone; 2, More marked increase in muscle tone through most of the ROM; 3, considerable increase in muscle tone; 4, affected part(s) rigid in flexion or extension.
次要结局
- the change from baseline to time of quality of life by Barthel Index(3rd week, and 6th week)
- the change from baseline to time of functional performance by STEF(3rd week, and 6th week)
- the change from baseline to time of functional performance by Wolf Motor Function Test(3rd week, and 6th week)
- the change from baseline to time of Brunnstrom stage(3rd week, and 6th week)
- the change from baseline to time of quality of life by Stroke Impact Scale(3rd week, and 6th week)
- the change from baseline to time of modified Tardieu scale(3rd week, and 6th week)
- the change from baseline to time of existence of sensation(3rd week, and 6th week)
- the change from baseline to time of functional performance by box and block test(3rd week, and 6th week)