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临床试验/NCT07401108
NCT07401108进行中(未招募)不适用

Reactive Balance Training Versus Virtual Reality on Balance and Functional Abilities in Children With Hemiplegia

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Limits of stability scores

研究概览

简要总结

This randomized controlled study compared the effects of Wii Balance Board training versus reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy. Sixty children aged 6-10 years (GMFCS levels I-II, mild spasticity) were randomly assigned to either a Wii-based balance training group or a reactive balance training group. Both groups received a conventional physical therapy program three times per week for eight weeks, with an additional 30 minutes of the assigned balance intervention per session. Balance and functional abilities were assessed before and after treatment using the HUMAC Balance System, Pediatric Balance Scale, Functional Reach Test, and Timed Up and Down Stairs test. The study aimed to evaluate and compare the effectiveness of both interventions in improving balance control and functional performance in this population.

详细描述

This study was conducted as a randomized controlled trial to investigate and compare the effects of Wii Balance Board-based virtual reality training and reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy.

Study Design and Participants

Sixty children with spastic hemiplegia of both genders were recruited from Wahet Nour Elhayah Centers. Participants were aged between 6 and 10 years, classified as GMFCS levels I and II, and demonstrated mild spasticity (grades 1-1+ on the Modified Ashworth Scale). All children were able to follow verbal instructions and participate actively in assessment and treatment procedures. Children with musculoskeletal deformities, recent orthopedic surgery or botulinum toxin injections, uncontrolled seizures, cardiovascular or respiratory disorders, or visual or hearing impairments were excluded.

Participants were randomly allocated into two equal groups (Group A and Group B) using a simple randomization method.

Intervention Program

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
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Hemiplegic children between 6-10 years old.
  • Both genders will be included.
  • Their motor function will be between level I and II according to Gross Motor Function Classification System (GMFCS) .
  • The degree of spasticity for these children will range from grade 1 to 1+ according to the Modified Ashworth Scale .
  • They will be able to follow instructions during evaluation and treatment procedures

排除标准

  • Cardiovascular or respiratory disorders.
  • Undergone musculoskeletal surgery or botulinum toxin injection in the lower limbs in past six months
  • Musculoskeletal problems or fixed deformities in the spine and/or lower extremities
  • unstable seizures
  • Visual or hearing impairment

研究组 & 干预措施

Virtual reality using Wii Balance Board

Experimental

The Wii Balance Board is a non-immersive virtual reality (VR) rehabilitation tool that has been widely used in physical therapy to assess and train balance and postural control. It is a force-platform-based device equipped with four pressure sensors (anterior-posterior and medial-lateral) that detect changes in body weight distribution and shifts in the center of pressure (CoP). These data are transmitted in real time to the Nintendo Wii console, where body movements are translated into visual feedback displayed on a screen, allowing users to interact with virtual environments and game-based tasks.

干预措施: Virtual reality (Device)

Reactive Balance training

Experimental

Participants will undergo structured reactive balance training that will consist of three sessions per week over an eight-week period. In Reactive balance training we will use different types of perturbations: External perturbations, Internal perturbation and combination of them. Training will last about 30 minutes.

干预措施: Reactive Balance Training (Other)

结局指标

主要结局

Limits of stability scores

时间窗: From enrollment to the end of treatment at 8 weeks

The Humac Balance System will be used for assessment of balance through limits of stability (LOS) scores. Higher scores indicate better dynamic balance control

center of pressure scores

时间窗: From enrollment to the end of treatment at 8 weeks

The Humac Balance System will be used for assessment of balance through center of pressure (COP) scores. Lower values indicate better posture control

次要结局

  • Functional reach test scores(From enrollment to the end of treatment at 8 weeks)
  • Timed up-and-down-stairs test scores(From enrollment to the end of treatment at 8 weeks)

研究者

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

Esraa Abd Elaziz Anter

lecturer

Cairo University

研究点 (1)

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