Biodex Balance Training With Transcutaneous Electrical Nerve Stimulation for Children With Spastic Diplegia: A Double-blinded, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- spatio-temporal gait parameters
研究概览
简要总结
Children with spastic diplegic Cerebral Palsy (CP) often show motor impairment due to a number of deficits; including poor muscle control, weakness, spasticity and reduced range of motion in the extremities. All these factors affect the ability of children with CP to maintain balance and walk which are the primary rehabilitation concerns of parents and clinicians. The Balance Trainer provides a safe balance environment and assists with muscle activation of ankle and hip joints, and it is hypothesized that to promote spasticity inhibition, the use of TENS may decrease hyper-excitability, modulate reciprocal inhibition, and increase presynaptic inhibition. To the best of the authors' knowledge, the current study is the first research to investigate the effect of using Biodex balance training with TENS in improving children with spastic diplegia.
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)
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of spastic diplegia cerebral palsy.
- •Age from 10 to 12 years.
- •Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
- •Level II motor function according to the Growth Motor Function Classification System.
- •Able to understand and follow instructions.
- •Their heights are more than 100 cm and weights are more than 20 Kg which are the lower limits of height and weight needed by the Biodex stability system.
排除标准
- •Epilepsy.
- •Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
- •Structural or fixed soft tissue deformities of the lower extremities.
- •Neurological or orthopedic surgery in the past 12 months.
- •Botox injection in the lower extremities in the past 6 months.
- •Fracture, sprain, or strain injury of the lower extremities in the past 6 months.
结局指标
主要结局
spatio-temporal gait parameters
时间窗: change from base line at 4 weeks.
Spatiotemporal gait parameters (Walking Speed (WS) (m/s), Step Length (SL) (cm) and the Stance Time (ST) (%) on each limb) using GAITRite system which has excellent reliability for measuring most spatio-temporal gait parameters. The GAITRite is a 700 cm × 90 cm electronic walkway with an active sensor area of 610 cm long and 60 cm wide. The active area contains 23,040 embedded pressure-activated sensors with a spatial resolution of 1.27 cm and a sampling rate of 120 Hz. All data was processed and stored by an IBM compatible computer using GAITRite® gold, Version 3.2b software.
hip adductor spasticity
时间窗: change from base line at 4 weeks.
spasticity of hip adductors will be measured by the Modified Ashworth Scale. Modified ashworth scale grades of spasticity are as follows: 0 = normal muscle tone; 1= slight increase in muscle tone, manifested by catch and release or by minimal resistance at the end; 1+ = slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout; 2= more marked increase in muscle tone, but limb easily flexed; 3= considerable increase in muscle tone, passive movement difficult; and 4 = limb rigid in flexion or extension.
balance assessment
时间窗: change from base line at 4 weeks
anteroposterior stability index, mediolateral stability index, and overall stability index will be measured using Biodex balance system. Biodex Stability System has an intertester intraclass correlation coefficients (ICCs) equals 0.70 and an intratester ICCs equals 0.82. Biodex Stability System formed of a dynamic platform that allows movements to occur around the anterior-posterior (AP) and mediallateral (ML) axes simultaneously. Biodex Stability System has a screen displaying the child's position on it and a support handle that can be adjusted according to each child's height. The screen gives visual feedback about the degree of tilting that helps the child to maintain the cursor in the center of the screen to obtain a good score of balance. The higher the scores, the poorer the balance of the child
次要结局
未报告次要终点
研究者
Marwa Shafiek Mustafa Saleh
assistance professor doctor
Cairo University