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临床试验/NCT04768374
NCT04768374已完成不适用

Effects of Virtual Reality on Cerebral Palsy; A Single-blind, Randomized Control Study: 3 Months Follow-up

Hacettepe University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年1月5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
83
试验地点
1
主要终点
Change in Independence in Activities of Daily living (assessed with Abilhand-kids)

研究概览

简要总结

Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP) rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a computer or a game console, and players interact with real-like objects . Using a VR interface as a rehabilitation tool increases the fun received by the client which, in turn, increases the participation of the client to the rehabilitation sessions.

This is a study that focused on long-term effects of Virtual reality (VR) intervention on motor skills and activities of daily living (ADL) independence of children with CP.

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 (Participant)

入排标准

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

入选标准

  • •had to be 7 to 12 years-old,
  • •to be diagnosed with CP,
  • •to get 1 or 2 from Gross Motor Functioning Classification System,
  • •to get a score of 1 to 3 from Manual Ability Classification System,
  • •to score at least 23 from Mini Mental State Examination - children edition,
  • •to be able to follow verbal instructions, and
  • •to have the

排除标准

  • •having any surgical operation and/or botulinum toxin injection in last 6 months,
  • •having any visual and hearing diseases that may affect using VR, and
  • •participating in any other rehabilitation programs (such as physiotherapy, speech therapy, psychotherapy etc.),
  • •having ataxic and/or dyskinetic symptoms.

研究组 & 干预措施

VR group

Experimental

Enrolled into 12 week VR intervention with Microsoft Kinect (twice a week, for 45 minutes) and conventional occupational therapy.

干预措施: Conventional Occupational Therapy (COT) (Other)

VR group

Experimental

Enrolled into 12 week VR intervention with Microsoft Kinect (twice a week, for 45 minutes) and conventional occupational therapy.

干预措施: Virtual Reality with Kinect (Other)

Control group

Active Comparator

Control group only received conventional occupational therapy for 12 weeks

干预措施: Conventional Occupational Therapy (COT) (Other)

结局指标

主要结局

Change in Independence in Activities of Daily living (assessed with Abilhand-kids)

时间窗: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)

ABILHAND-Kids is a scale that was developed to evaluate activities of daily living (ADL) requiring upper limb usage of children aged between 6-15 years

Change in motor proficiency( assessed with Bruninsk-Oseretsky Test of Motor Proficiency 2-Brief Form (BOT2-BF))

时间窗: Baseline, 12th week (end of intervention), 24th and 36th week(follow up)

BOT2-BF is a test that evaluates motor proficiency and allows therapists to compare results with specified norm values

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

Orkun Tahir Aran

PhD.

Hacettepe University

研究点 (1)

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