跳至主要内容
临床试验/NCT04839939
NCT04839939已完成不适用

Short Term Efficacy of Combination Taping Technique as an Alternative to Ankle Foot Orthosis on Improving Gait Parameters in Spastic Cerebral Palsy: A Controlled Randomized Study

Batterjee Medical College2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Stride Length (cm)

研究概览

简要总结

Gait in children with spastic CP is often characterized by abnormal gait kinematics as knee flexion and equines foot which associated with such gait deviations, an elevated walking energy cost is often observed which may contribute to activity limitations.

The ability to maintain proper joint alignment of the lower extremity, and control the position of the foot in standing and walking is a critical treatment objective for gait in children with cerebral palsy. Lower extremity orthoses, such as ankle-foot orthoses (AFOs) are widely recommended in children with spastic cerebral palsy to prevent the development or progression of this deformity and to improve the dynamic efficiency of the child's gait. The use of Kinesio taping in pediatric rehabilitation becomes increasingly popular in recent years. Recent systematic reviews reported moderate evidence that Kinesiology taping is a useful adjunct to physiotherapy intervention in higher functioning children with CP. Combination tapings is a technique first introduced by Kenzo Kase, in which Kinesio taping is coupled with the rigid athletic tape to maximize the treatment benefits. This approach remains briefly addressed in the literature with no prior studies has examined the effects of combination tapings in the CP pediatric population. Hypothesis: there is no difference between the effect of combining tapings and ankle-foot orthosis on spatiotemporal gait parameters in spastic cerebral palsied

详细描述

This study was designed as a randomized controlled trial. The participants and their parents were given clear, detailed explanation of the proposed procedures before starting the experiment, and signed a written informed consent statement. Batterjee Medical College Research and Ethical committee reviewed and approved the study, which were conducted in compliance with the 1975 Helsinki Declaration. Thirty-six children (22 males and 14 females) with spastic diplegic cerebral palsy were enrolled in this study. The children were randomly assigned into two study groups (A & B), and a control group (C). Randomization was done by asking each child to pick up an index card out of a box that contains 36 cards (12 cards for each group) to determine which group participants would be in. Measurements were taken in two occasions, baseline, and four weeks after application of the intervention. Spatiotemporal Gait parameters were measured as per the published guidelines using the GAITRite system. Parameters included were cadence, step length; stride length, single support time, double support time, and velocity were evaluated.

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
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age range from 8 to 15 years old
  • Able to stand and walk independently
  • Spasticity ranged from 1 to 1+ grade according to Modified Ashworth Scale
  • level I or II according to Gross Motor Function Classification System (GMFCS)
  • Able to understand and follow instructions

排除标准

  • Children with previous corrective orthopedic surgery or botulinum toxin injection in the lower extremities within the previous 6 months
  • Skin disease
  • Mental retardation
  • Visual or auditory problems

结局指标

主要结局

Stride Length (cm)

时间窗: 4 Weeks

Change of the stride length was measured using GAITRite System

Cadence (step/min)

时间窗: 4 weeks

Change of the cadence was measured using GAITRite System

Single leg support (% of gait cycle)

时间窗: 4 weeks

Change of the single leg support was measured using GAITRite System

Double leg support (% of gait cycle)

时间窗: 4 weeks

Change of the double leg support was measured using GAITRite System

Step Length (cm)

时间窗: 4 Weeks

Change of the step length was measured using GAITRite System

Velocity (cm/s)

时间窗: 4 weeks

Change of the velocity was measured using GAITRite System

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed A. Abdel Ghafar

Associate Professor

Batterjee Medical College

研究点 (2)

Loading locations...

相似试验

Efficacy of Combination Taping Technique vs Ankle... | 临床试验