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临床试验/NCT04802655
NCT04802655已完成不适用

Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality

Ahmet Emir1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年3月11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
发起方
入组人数
25
试验地点
1
主要终点
Upper Limb Kinematics - Range of Motion Analysis

研究概览

简要总结

The aim of the study is to investigate effects of structured exergame program on upper extremity functions and trunk control in children with Cerebral Palsy (SP). A 3 phase randomized controlled trial has planned to conduct. In the first phase, baseline assessments will be completed for all participants who are eligible to participate. After the baseline assessments, randomisation will be completed for Exergame and Activity Based Exercise groups. During this phase suitable video games for exergame program will be selected. Analytical Hierarchy Process (AHP) will be used to collect expert opinion for most effective video games for upper extremity functionality, postural control, GMFCS I-II-III levels. Second phase of the study will be started afterwards. Upon completing second assessments, interventions for both groups will be conducted. Third assessments will be completed after interventions and outcomes will be analyzed for primary results. The third phase of the study planned as follow-up period. All participant will continue their routine NDT trainings and follow-up assessments will be completed after 3 moths of the second assessments. Final results will be analysed for all participants.

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
Double (Participant, Care Provider)

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with spastic cerebral palsy
  • •Gross Motor Level should be in between I-III according to Gross Motor Function Classification System (GMFCS)
  • •Manual ability levels should be in between I-IV according to Manual Abilities Classification System (MACS)
  • •No Botulinum toxin injections 6 months prior to study

排除标准

  • •Surgery history related to the musculoskeletal system (upper and lower extremities)
  • •Having communication problems
  • •Having secondary cognitive-behavioral problems addition to cerebral palsy (intellectual disability)

研究组 & 干预措施

Exergame Group (EG)

Experimental

In addition to routine NDT training, Structured Exergame Program for upper extremity and trunk control will be applied in this group. Xbox one - Kinect supported video games will be selected for video-game based exergame program. The Video games to be included in the Exergame program will be selected by Analytical Hierarchy Process. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks.

干预措施: Video-game based exercise - Exergame (Other)

Activity Based Exercise Group (AG)

Active Comparator

In addition to routine NDT training, Goal Directed Activity Based Exercises for upper extremity and trunk will be applied to this group. Program will consist 40 minutes of exergame sessions and 15 sessions total. Sessions will be applied 2 times a week, and It is planned to complete in 8 weeks.

干预措施: Activity Based Exercise Group (AG) (Other)

结局指标

主要结局

Upper Limb Kinematics - Range of Motion Analysis

时间窗: 10 minutes

Upper limb kinematics analysis for range of motion assessments will be conducted via Kinovea 2D motion analysis software. Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist Range of Motion (ROM) values (in degrees) each pivots will be analyzed afterward.

Upper Limb Kinematics - Angular velocity

时间窗: 10 minutes

Upper limb kinematics analysis for angular velocity will be conducted via Kinovea 2D motion analysis software.Analysis will be conducted during 1 selected activity which is putting glasses into shelves. Reflective markers will be placed on the lateral side of head, shoulder, elbow and hand. Video recordings will be completed from the affected side of the body laterally. Shoulder, elbow and wrist angular velocity (mm/s) of each pivots will be analyzed afterward.

Trunk Control Measurement Scale (TCMS)

时间窗: 15 minutes

Trunk Control Measurement Scale (TCMS) is a clinical tool to measure trunk control in children with cerebral palsy. TCMS measures the trunk control in two basic components that are static and dynamic sitting balance. Dynamic sitting balance is divided into two parts as selective movement control and dynamic reaching. The static sitting balance part evaluates trunk control during upper and lower limbs' movements in the sitting position. Balance is assessed during flexion, extension, lateral flexion and rotation movements as selective movements of dynamic sitting. Reaching part of dynamic sitting balance evaluates trunk balance during reaching at different planes. The scale consists of 15 items. Each part has 5,7 and 3 items respectively. Total score ranges between0 and 58 and higher scores reflect better control.

次要结局

  • Selective Control of Upper Extremity Scale (SCUES)(15 minutes)
  • Jebsen Taylor Hand Function Test (JTHFT)(10 minutes)
  • Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)(15 minutes)

研究者

发起方
Ahmet Emir
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmet Emir

Lecturer

Medipol University

研究点 (1)

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