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临床试验/NCT06303440
NCT06303440已完成不适用

Effects of Virtual Reality Versus Motor Imagery on Balance, Gross Motor Function and Activities of Daily Living in Children With Cerebral Palsy.

Riphah International University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年2月25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
入组人数
63
试验地点
2
主要终点
Gross Motor Function Classification System

研究概览

简要总结

Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.

详细描述

This randomized controlled trial will be conducted at Rising Sun Institute. The sample size calculated for this trial will be 75. The participants will be randomly allocated using online randomization tool into three groups; Group A will receive routine physical therapy (PT) for 30 minutes with additional selected exercises for 15 minutes, Group B will receive VR training for 15 minutes with routine PT for 30 minutes, and Group C will receive MI for 15 minutes and routine PT for 30 minutes. Each participant will receive treatment for three days on alternative days per week for 12 weeks. Gross Motor Function Scale (GMFCS) will be used for balance, Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) for motor function, and WeeFIM scale for ADLs at baseline, 8th week, 12th week, and at 16th week after discontinuation of treatment.

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 (Outcomes Assessor)

盲法说明

The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children of 7-12 years of both genders, Children with Mini Mental Scale score >
  • Children with Gross motor function classification system (GMFCS) level I and II and able to follow and accept verbal instruction.

排除标准

  • History of any Visual and Hearing Impairments, Virtual game phobia.
  • History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs and Children with history of severe cardiopulmonary disease, History of epilepsy, History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection.

研究组 & 干预措施

Group A (Routine Physical Therapy+ Balance Training)

Other

The children will be provided with Routine Physical Therapy and Balance Training.

Balance exercises will be provided for 15 minutes and 30 minutes of Routine physical therapy will be as strengthening and stretching exercises.

干预措施: Routine Physical Therapy+ Balance Training (Other)

Group B (Virtual Reality + Routine Physical Therapy)

Experimental

The VR system consisted of a wall-mounted display, a Nintendo Wii box, a Wii remote, and a Wii Fit board. The participants will be instructed to stand on Wii Fit board while interacting with the VR system and playing the selected games and routine physical therapy of 30 minutes will be provided.

干预措施: Virtual Reality+ Routine Physical Therapy (Other)

Group C (Motor Imagery+ Routine Physical Therapy)

Experimental

During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video

干预措施: Motor Imagery+ Routine Physical Therapy (Other)

结局指标

主要结局

Gross Motor Function Classification System

时间窗: 12 weeks

Gross Motor Function Classification System will be used to measure balance

Bruininks-Oseretsky Test of motor function Proficiency-2

时间窗: 12 Weeks

It will be measured with Bruininks-Oseretsky Test of motor function Proficiency-2 for motor function.

Functional Independence Measure for Children

时间窗: 12 Weeks

Functional Independence Measure for Children scale will be used to determine the Activities of Daily Living improvement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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