The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- The Fugl-Meyer assessment scale
研究概览
简要总结
The patients between the ages of 35-80 who developed spasticity in the upper extremity after stroke will be included.. Botulinum toxin(BT-A) injection will be applied to the study group(n=16) and placebo injection to the control group(n=15) in addition to conventional rehabilitation and stretching exercises. Evaluations will be made before the treatment, in the 2nd week, and in 3rd month after the treatment. Pain relief will be evaluated with the Visual Analog Scale(VAS) and spasticity assessment will be done with the Modified Ashworth Scale(MAS). The functionality will be evaluated with Fugl Meyer Assessment Scale(FMAS) and Box Block Test(BBT).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemiplegia due to a cerebrovascular accident at least 1 month ago
- •cognitively competent
- •have spasticity of 1 and above according to the Modified Ashworth Scale
- •receive at least 3 cubes in the Box Block Test
排除标准
- •Patients with upper extremity brachial plexus lesions,
- •shoulder subluxation,
- •arthritis and joint contracture,
- •neglect syndrome,
- •cerebellar and brain stem lesions
- •those who did not accept the study
研究组 & 干预措施
Study Group
This is the group that will be injected with botulinum toxin for spasticity and stretching exercises will be given.
干预措施: Botulinum toxin type A (Drug)
Control Group
This is the group that will be injected with %0,9 NaCl for spasticity and stretching exercises will be given.
干预措施: %0,9 NaCl (Drug)
结局指标
主要结局
The Fugl-Meyer assessment scale
时间窗: 2 weeks after treatment
The Fugl-Meyer assessment scale (FMAS) will be used to evaluate the motor functions of the upper extremity.
Range of Motion
时间窗: 2 weeks after treatment
Passive flexion, abduction and external rotation of the shoulder, supination of the elbow, and extension of the wrist will be evaluated by the same physician by goniometry. In addition, elbow, proximal interphalangeal, and distal interphalangeal joints will be evaluated as a limitation of extension.
Modified Ashworth Scale
时间窗: 2 weeks after treatment
The modified Ashworth Scale (MAS) will be used to evaluate spasticity. The adductor, internal rotator of shoulder, flexor of elbow, wrist and finger, pronator of elbow spasticities will be evaluated using MAS while the patient was in the sitting position.
Pain - Visual Analog Scale
时间窗: 2 weeks after treatment
The shoulder pain of the patients will be evaluated during passive movement of the shoulder joint. The Visual Analogue Scale (VAS), a score between 0 and 10, will be used in the evaluation.
次要结局
- Pain - Visual Analog Scale(3 months after treatment)
- Range of Motion(3 months after treatment)
- Modified Ashworth Scale(3 months after treatment)
- The Fugl-Meyer assessment scale(3 months after treatment)
研究者
Aylin Ayyıldız
Medical Doctor
Sisli Hamidiye Etfal Training and Research Hospital