Efficacy of Neuromuscular Electrical Stimulation and Interrupted Serial Casting in Children With Spastic Diplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of knee and ankle passive range of motion (ROM)
研究概览
简要总结
Combining the advantages of both Neuromuscular electrical stimulation and lower limb serial casting to a selected physical therapy program in children with spastic diplegic cerebral palsy to overcome the adverse effects during the period of casting and the long period of rehabilitative interventions, providing a new multimodal treatment approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The children will have grade 2 or 3 on Modified Ashworth Scale.
- •The children will have Level II, or III according to the Gross Motor Function Classification System.
- •The children walk with equinus or jump gait patterns with spasticity of the hamstrings and hip flexors in addition to calf muscles spasticity.
- •Children take their Antispastic drug use such as baclofen, diazepam or tizanidine.
- •All children will be able to follow instructions.
排除标准
- •children will be excluded from the study if they have any problems of the following:
- •Cognitive dysfunction.
- •Poor skin integrity.
- •History of or recent nonunion fracture.
- •Fixed contractures and deformities.
- •Previous surgery (tendon lengthening).
- •Received Botulinum toxin A injections in the last six months.
- •Impaired circulation.
结局指标
主要结局
Change of knee and ankle passive range of motion (ROM)
时间窗: At the beginning and after six weeks of intervention
Digital Goniometer will be used to measure the passive ROM of ankle dorsiflexion and the popliteal angle (PA)
Change of strength of knee extensors and ankle dorsiflexors muscles
时间窗: At the beginning and after six weeks of intervention
Hand-held dynamometers (HHDs) " Lafayette manual muscle tester" (MMT) Will be used for quantitative assessment of maximal voluntary isometric contraction for knee extensors, and ankle dorsiflexors.
Change of tone of hamstring and gastrocnemius muscles
时间窗: At the beginning and after six weeks of intervention
The Modified Tardieu Scale (MTS) will be used for analysis of dynamic spasticity of gastrocnemius and hamstring muscles. Measuring R1 (the fast velocity movement of the ankle or knee through the full ROM to determine the point of catch in the ROM), R2 (the passive ROM), and R2-R1 (dynamic component of spasticity).
次要结局
- Change in sagittal kinematics parameters of gait pattern(At the beginning and after six weeks of intervention)
研究者
Yasser Mamdouh Abd Elmonem Mohamed
Principal investigator
Cairo University