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临床试验/NCT07421193
NCT07421193已完成不适用

The Effect of Video-Based Games on Upper Extremity Function and Activity Participation in Children With Hemiparetic Cerebral Palsy

Pamukkale University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年10月1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
24
试验地点
1
主要终点
Duruöz Hand Index

研究概览

简要总结

Aim:

The present study aimed to systematically evaluate the effects of video-based gaming on upper extremity motor function and activity participation in children with hemiparetic cerebral palsy (CP). Specifically, it investigated whether Microsoft Xbox Kinect games leveraging motion-detection technology, when added to conventional neurodevelopmental therapy (NGT), would provide additional benefits in motor skill development, independence in activities, social engagement, motivation, and treatment adherence compared to NGT alone.

Materials and Methods:

Twenty-four children aged 7-13 years with hemiparetic CP, classified as Level I-III on the Gross Motor Function Classification System (GMFCS) and Level 1-3 on the Manual Ability Classification System (MACS), were recruited. Participants were randomized into intervention (n=12) and control (n=12) groups. The control group received NGT four times per week (45-minute sessions) over a 12-week period. The intervention group received two NGT sessions and two Xbox Kinect gameplay sessions per week, each lasting 45 minutes, over the same duration.

Outcome measures included the Nine-Hole Peg Test (9HPT) to assess timed hand performance, the Duruöz Hand Index (DHI) to evaluate skill-based hand function, and the Assistance to Participation Scale (APS) to assess participation in daily activities. All assessments were conducted by a blinded expert physiotherapist at baseline and after the intervention period.

详细描述

A total of 27 children meeting the inclusion criteria will be enrolled in the study, and demographic information will be recorded using a standardized data collection form. Participants who do not complete the intervention protocol will be withdrawn from the study. Eligible participants will be randomly assigned to either the study group or the control group using a simple randomization method.

Participants in the control group will receive neurodevelopmental treatment (NDT) four times per week, with each session lasting 45 minutes, for a total duration of 12 weeks. Participants in the study group will receive NDT twice per week (45 minutes per session) in addition to video-based gaming training using Microsoft Xbox twice per week (45 minutes per session) for 12 weeks.

Outcome assessments will be conducted at baseline and at the end of the 12-week intervention period by an experienced physiotherapist who will be blinded to group allocation. Upper extremity performance will be assessed using the Nine-Hole Peg Test (9HPT), hand function will be evaluated using the Duruöz Hand Index (DHI), and participation in daily activities will be assessed using the Assistance to Participation Scale (APS).

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
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged between 7 and 13 years
  • diagnosis of spastic hemiparetic cerebral palsy
  • participants to be classified at levels I, II, or III according to the Gross Motor Function Classification System (GMFCS) and at levels I, II, or III according to the Manual Ability Classification System (MACS).

排除标准

  • Children who had undergone upper extremity tendon release surgery or received botulinum toxin injections within the previous six months
  • additional neurological disorders other than cerebral palsy
  • permanent orthopedic conditions affecting upper extremity function

研究组 & 干预措施

Control

Active Comparator

Participants in the control group received neurodevelopmental treatment (NDT) four times per week, with each session lasting 45 minutes, for a total duration of 12 weeks.

干预措施: neurodevelopmental treatment (NDT) (Other)

Study

Experimental

Participants in the study group received NDT twice per week (45 minutes per session) in addition to video-based gaming training using Microsoft Xbox twice per week (45 minutes per session) for 12 weeks.

干预措施: neurodevelopmental treatment (NDT) (Other)

Study

Experimental

Participants in the study group received NDT twice per week (45 minutes per session) in addition to video-based gaming training using Microsoft Xbox twice per week (45 minutes per session) for 12 weeks.

干预措施: Video-Based Gaming Training Using Microsoft Xbox (Other)

结局指标

主要结局

Duruöz Hand Index

时间窗: Baseline and immediately after the end of the treatment

The Duruöz Hand Index is an 18-item questionnaire designed to evaluate hand functional capacity. The index consists of five domains: kitchen activities, dressing, personal hygiene, work-related activities, and other daily activities. The questionnaire was completed by parents or caregivers. Responses are scored on a 6-point Likert scale ranging from 0 ("no difficulty") to 5 ("impossible"), yielding a total score between 0 and 90. Higher scores indicate greater impairment of hand function. The validity and reliability of the index for children aged 7-16 years with spastic hemiparetic cerebral palsy have been demonstrated previously.

Assistance to Participation Scale

时间窗: Baseline and immediately after the end of the treatment

The Assistance to Participation Scale was developed by Bourke-Taylor, Law, Howie, and Pallant to assess the level of assistance required by school-aged children (5-18 years) with developmental disabilities to participate in play, leisure, and recreational activities from the caregiver's perspective. The scale consists of eight items, including activities such as watching television, listening to music, playing alone at home, playing outdoors near home, spending time with friends at home or at a friend's house, visiting playgrounds, and participating in recreational clubs. Items are rated on a 5-point Likert scale, with lower scores indicating lower participation levels and higher scores indicating greater participation.

Nine-Hole Peg Test

时间窗: Baseline and immediately after the end of the treatment

The Nine-Hole Peg Test was used to assess fine motor skills of the fingers and hand for both upper extremities. Participants were instructed to place nine pegs (3.2 cm in length) into holes on a pegboard as quickly as possible using the dominant hand, followed by removal of the pegs in sequence. The total time required for insertion and removal was recorded in seconds, and the same procedure was repeated for the non-dominant hand. Insertion and removal times for both hands were documented separately. During the task, palmar, lateral, and hook grasp patterns were predominantly observed.

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

Fatih Tekin

Assoc. Prof.

Pamukkale University

研究点 (1)

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