Enhancing Gross Motor Function and Knee Extensor Strength During Loaded Gait Training in Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Gross motor function
研究概览
简要总结
A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. Children were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. Gross motor functions and knee extensor strength were measured.
详细描述
A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy (CP).
52 children with bilateral spastic CP, aged 5 to 7 years, were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training 3 times per week for an hour for 3 months.
Gross motor functions were measured by the Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains, while knee extensor strength was measured by a hand-held dynamometer.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinding. Parents were also blinded.
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: five to seven years old, classified as levels II and III on the GMFCS.
- •Spasticity grade from 1+ to 2 based on the Modified Ashworth scale.
- •Able to understand and follow verbal commands and instructions (with a score above 80 on the Stanford Binet Intelligence Scale).
排除标准
- •Genetic or metabolic disorders.
- •Brain tumours.
- •Musculoskeletal dysfunction that would interfere with our intervention (e.g. tightness of the posterior knee joint capsule that causes passive knee extension lag, or fixed contracture of the knee joint).
- •Surgical intervention in the lower limbs within the preceding 12 months.
- •Botulinum toxin injections in lower limb muscles within the last six months.
结局指标
主要结局
Gross motor function
时间窗: 1 year
Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains.
knee extensor strength
时间窗: 1 year
Knee extensor strength was measured by a hand-held dynamometer.
次要结局
未报告次要终点
研究者
Amina Awad,PhD
Associate Professor
Cairo University