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临床试验/NCT05787977
NCT05787977已完成不适用

The Effect of Treadmill Training With Visual Feedback and Rhythmic Auditory Cue on Gait and Balance in Cerebral Palsy

Sehat Medical Complex2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Pediatric Balance scale

研究概览

简要总结

The development of efficient and independent walking is an important therapeutic goal for many children with cerebral palsy (CP). Consequently, there has been growing interest in determining the effects of treadmill training programs for these children.

This study helped to investigates the effect of treadmill training with visual feedback and rhythmic auditory cue (VF+RAC) for walking symmetry and balance ability. Participants were chosen from Sehat medical complex and they were randomly allocated to either the VF+RAC or the Control group. The VF+RAC group received treadmill training with VF and RAC, and the Control group undergo treadmill training without any visual and auditory stimulation. VF+RAC and Control groups was trained five times per week for eight weeks. After eight weeks of training the gait pattern and balance were evaluated by the gait parameters, 6min Walk test, Pediatric Balance Scale and Berg balance scale.

详细描述

Cerebral palsy is the most common cause of childhood-onset, lifelong physical disability in most countries, affecting about 1 in 500 neonates with an estimated prevalence of 17 million people worldwide. Cerebral palsy is a non-progressive brain injury or lesion acquired during the antenatal, perinatal or early postnatal period. The clinical manifestations of cerebral palsy vary greatly in the type of movement disorder, the degree of functional ability and limitation and the affected parts of the body.

Auditory entrainment can influence gait performance in movement disorders. The entrainment can incite neurophysiological and musculoskeletal changes to enhance motor execution. Biofeedback systems have been extensively used in walking exercises for gait improvement.

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
Single (Investigator)

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children having GMF level 1 and 2,
  • willing to participate,
  • Pediatric subjects Diagnosed with cerebral palsy, receiving Neurodevelopmental
  • Rehabilitation program regularly.

排除标准

  • Child using any sort of auditory aid
  • Children with visual limitation,
  • Child using orthosis for lower extremity

研究组 & 干预措施

Interventional Group

Experimental

Treadmil Training with visual feedback and rhythmic Auditory Cue

干预措施: Visual Feedback and Rhythmic Auditory Cue (Other)

Control Group

No Intervention

No intervention

结局指标

主要结局

Pediatric Balance scale

时间窗: Change from baseline at 8th Week

The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

6 Minutes Walk Test

时间窗: Change from baseline at 8th week

The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

Berg Balance Scale

时间窗: Change from baseline at 8th week

The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

次要结局

未报告次要终点

研究者

发起方
Sehat Medical Complex
申办方类型
Other
责任方
Sponsor

研究点 (2)

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