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临床试验/NCT06478082
NCT06478082已完成不适用

Virtual Reality Gaming to Improve Upper Limb Functionality in Children With Cerebral Palsy

Sint Maartenskliniek2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年4月12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
13
试验地点
2
主要终点
Logbook

研究概览

简要总结

Rationale: In a way, VR-based gaming shows some similarities to Constraint-induced movement therapy. VR games are controlled unimanually or bimanually. When unimanually-controlled games are performed with the affected upper limb, movements of the unaffected hand are completely ineffective. This mimics the principle of forced use. To some degree, also bimanually-controlled games result in a forced use of the affected upper limb.

Additionally, VR could help in the engagement in rehabilitation programs, as virtual environments and gaming increases enjoyment and motivation, and therefore therapy adherence. Accordingly, VR-based gaming may have the potential to improve upper limb functionality in children with CP.

Objective: This study aims to investigate the feasibility of a home-based VR intervention to improve upper limb functionality in children with CP. Sub-objective: The validation of a self-developed upper limb assessment (Upper Limb Reaching Test).

Study population: Children and adolescents with unilateral CP (age 10-18 years old). Intervention: The intervention consists of VR-based rehabilitation with the Oculus Quest device. The training frequency and duration represents 2x15 minutes a day, five days a week, for a total of eight weeks. Therefore, this rehabilitation intervention should represent a total amount of 20 hours of rehabilitation. However, the total dosage is variable as the intervention is self-managed.

Main study parameters/endpoints: Logbook, System Usability Scale, Melbourne Assessment 2, Wall Arm Reaching Test, Elbow and shoulder range of motion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • CP children with a unilateral or severely asymmetric, bilateral spastic movement impairment.
  • Age 10-18 years old.
  • Manual Ability Classification System (MACS) scores I, II or III.
  • House classification of 1, 2 or 3.

排除标准

  • Significant (persisting) motion sickness, or any other related adverse event in VR.

结局指标

主要结局

Logbook

时间窗: During the 8-week intervention period

Participants keep a logbook in which they log the date of training, games played, duration of activity and enjoyment of game

System Usability Scale

时间窗: After the 8-week intervention

This questionnaire consists of 10 items regarding the usability of the virtual reality training. Scores ranging between 0-100, with a higher score indicating better usability

次要结局

  • Range of motion Elbow(Before and after 8-week intervention)
  • Rang om motion Shoulder(Before and after 8-week intervention)
  • Wall Arm Reaching Test(Before and after 8-week intervention)
  • Melbourne Assessment 2(Before and after 8-week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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