Impact Of Physiotherapy And Botulinum Toxin Type-A In Improving Functional Outcomes In Upper Limb Focal Dystonia Among Post Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- FUGL- MEYER ASSESSMENT TEST
研究概览
简要总结
This study was conducted to assess the combine role of Physiotherapy by providing task specific trainings and Botulinum Toxin Type A in improving the functional outcomes of upper limb in post stroke patients with focal hand dystonia.
详细描述
Post-stroke hemiparesis, with dystonia, is a major cause of disability. Dystonia can hinder the functional activities making patient dependent on others for performance of daily living activities. Dystonia not only limits the physical activity of the patient but also affects their quality of life significantly. Various treatment protocols have been used in the literature for treatment of focal hand dystonia in the past including deep brain stimulation, kinesio taping, sensory oriented training, splinting, extracorporeal shock wave therapy and botox. Out of these Botox has gained much importance but it results only in improving the passive range of motion and has no consensus in improving the active range of motion and functional independence of the patient. The current study was planned to determine the effects of botulinum toxin type A combined with task-specific therapy, for post-stroke focal dystonia of upper limb.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having first episode of unilateral stroke
- •At least 6 months of post stroke duration presenting with post stroke focal dystonia of the upper limb.
- •No previous exposure of the affected hand of Botox.
- •Reduced upper limb functions
- •Both genders will be included equally.
排除标准
- •Significant speech or cognitive impairment which impedes the ability to perform the assessment.
- •Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months.
- •Severe arthritis, amputation, evidence of fixed contracture, pregnancy or lactating womens.
- •Other diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. blind, malignancy,
- •Other conditions which may contribute to upper limb spasticity, e.g. multiple sclerosis, cerebral palsy.
- •Use of botulinum toxin to the upper limb in the previous 4 months.
- •Contraindications to intramuscular injection.
- •Contraindications /allergy to botulinum toxin type A, which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides.
研究组 & 干预措施
Experimental Group
The experimental group received botulinum toxin type A. After one week of Botox administration, a specially made task specific training program was started for these patients. It was provided for a duration of one hour and for three times per week for a total of 12 weeks by a trained physiotherapist.
干预措施: Task Specific Training (Other)
Control Group
The control group received only task specific training program with the same protocol as for the experimental group; for a duration of one hour and for three times per week up to a total of 12 weeks by a trained physiotherapist
干预措施: Task Specific Training (Other)
Experimental Group
The experimental group received botulinum toxin type A. After one week of Botox administration, a specially made task specific training program was started for these patients. It was provided for a duration of one hour and for three times per week for a total of 12 weeks by a trained physiotherapist.
干预措施: Botulinum toxin type A (Other)
结局指标
主要结局
FUGL- MEYER ASSESSMENT TEST
时间窗: 12 weeks
It was a performance-based impairment index to measure motor functioning. The total score possible was from 0 - 66, with higher function showing the improved level of independence
MOTOR ASSESSMENT SCALE (MAS)
时间窗: 12 weeks
It was a performance-based scale, based on a task-oriented approach to evaluate and assesses performance of functional tasks rather than isolated patterns of movement. All items were assessed using a 7-point scale from 0 - 6. A score of 6 indicated optimal motor behavior.
Action Research Arm Test (ARAT):
时间窗: 12 weeks
It assessed specific changes in limb function by 19 items grouped in four subscales. The total score ranged from 0 to 57. The lower score indicated no movement and upper score indicated normal performance of the patient.
WOLF MOTOR FUNCTION TEST (WMFT)
时间窗: 12 weeks
It quantified motor ability through timed functional tasks. It used a 6-point ordinal scale with "0" = "does not attempt with the involved arm" to "5" = movement appears to be normal."
次要结局
- Stroke Specific Quality Of Life(12 weeks)
- Severity Of Dystonia(12 weeks)
研究者
Muhammad Umar
Principal Investigator
Isra University