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临床试验/NCT04425980
NCT04425980已完成不适用

The Efficacy of Two Models of Intensive Upper Limb Training On Quality of Life in Children With Hemiplegic Cerebral Palsy Attending Regular School in Mus Province: A Randomized Controlled Trial

Muş Alparlan University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018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
发起方
入组人数
30
试验地点
1
主要终点
Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention

研究概览

简要总结

This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy

详细描述

A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period.

During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire

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)

盲法说明

by concealing the other allocated intervention from participants / unaware of the presence of a second intervention approach

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Clinical diagnosis of congenital hemiplegia,
  • •Must be able to grasp objects

排除标准

  • •Cerebral palsy dependent severe emotional difficulties

研究组 & 干预措施

Modified Constraint-Induced Movement Therapy (test treatments)

Experimental

A list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook a role as a dominant hand

干预措施: Modified Constraint-Induced Movement Therapy (Other)

Bimanual training

Active Comparator

For the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities

干预措施: Modified Constraint-Induced Movement Therapy (Other)

结局指标

主要结局

Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention

时间窗: From baeline to post-intervention, up to 16 weeks

The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents

次要结局

未报告次要终点

研究者

发起方
Muş Alparlan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan Bingöl

Academician (Lecturer

Muş Alparlan University

研究点 (1)

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