Gait Rehabilitation in Ambulant Diplegic Children Using BOTOX and Ankle Weights
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- evaluation of spasticity: modified ashowrth scale scores
研究概览
简要总结
Background: Standing and walking serve an individual's basic need to move from place to place, and both are the most common activities that people do on a daily basis.
Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle weight on the gait of diplegic children who are using Ankle foot orthoses.
详细描述
Methods: Sixty children with spastic diplegia were included in this prospective, controlled trial. Children were divided into three groups, each with 20 patients: Group 1 received classical gait rehabilitation; Group 2 received the same gait training while adding ankle weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex ratio were used to examine patients before the commencement of treatment and post-treatment.
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
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as spastic diplegia.
- •They were able to follow simple verbal instructions.
- •The use of Ankle Foot Orthoses.
- •Spasticity grade of 1+ or 2 in both calf and hamstring muscles according to modified Ashworth's scale (MAS).
- •level I or II on the Gross Motor Function Classification System (GMFCS).
排除标准
- •fixed contractures or deformities in the lower limbs.
- •surgical orthopedic intervention.
- •Botulinum A injection or use of neuromuscular blockers in the previous 6 months before the start of study.
结局指标
主要结局
evaluation of spasticity: modified ashowrth scale scores
时间窗: after 3 months of the treatment program.
hamstring and calf muscles evaluation of spasticity through passive movement .the score ranged from 0 ( nearly normal) to 5 (rigid in flexion or extension)
measurement of knee excursion during gait
时间窗: after 3 months of the treatment program.
evaluation of knee flexion range of motion during gait using two dimension gait analysis.
次要结局
- electromyography to asses spasticity in hamstring and calf muscles(after 3 months of the treatment program.)
研究者
Nahla Mohamed Ibrahim
lecturer physical therapy
Cairo University