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临床试验/NCT06532513
NCT06532513招募中不适用

Examination of the Effects of Family-Centered Goal-Oriented Physiotherapy and Rehabilitation Application on Body Functions, Activity, Participation and Quality of Life in Severely Affected Children With Dyskinetic Cerebral Palsy

Hacettepe University2 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
The Gross Motor Function Measure-88; The Gross Motor Function Measure-66

研究概览

简要总结

This study aimed to examine the impact of family centered, goal-oriented physiotherapy and rehabilitation on body function, activity, participation, and quality of life in severely affected children with dyskinetic cerebral palsy (DCP). The first assessment was conducted and recorded for all patients at the beginning of the study. Subsequently, the study group was taught family centered physiotherapy practices in addition to routine physiotherapy for 10 weeks to be performed at home. The control group only received routine physiotherapy. Weekly remote monitoring, regular meetings, and a second assessment at the 10th week were conducted. The study concluded with all face-to-face assessments.

According to the research protocol, the primary aim of this study was to evaluate the effectiveness of a 10-week family centered physiotherapy application. The goal of this intervention was to improve movement and posture, thereby enhancing daily activities and quality of life. The primary endpoint of the study was to determine the impact of family physiotherapy application taught to families during the 10-week education period.

This study was conducted at the Faculty of Physical Therapy and Rehabilitation, Hacettepe University. This study aimed to structure and define a family centered, goal-oriented, personalized physiotherapy, and rehabilitation application for the treatment of children with cerebral palsy. One of the significant objectives of this study was to examine the effects of this intervention within the framework of the International Classification of Functioning, Disability, and Health (ICF) on body function, activity, participation, and quality of life. The study protocol started with evaluations from patients after obtaining approval from the ethics committees.

The study will be completed within a follow-up period of four months without treatment, including the remote monitoring process. The results of this study aimed to provide valuable information about the effectiveness of family centered physiotherapy application in severely affected children with dyskinetic cerebral palsy.

详细描述

This study aimed to investigate the impact of family centered goal-directed physiotherapy and rehabilitation intervention on body function, activities, participation, and quality of life in children with severely affected dyskinetic cerebral palsy. Within this scope, an intervention program was designed to enhance children's functional performance in their daily life activities. The focal points of this research included pain, fatigue, sleep problems, and parental stress levels. The goal of this intervention was to improve children's movement and posture, increase their independence in daily life activities, and enhance their overall quality of life. This study aimed to assess the effectiveness of family centered interventions in children with cerebral palsy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • Being in the age range of 5-18 years
  • Having a diagnosis of Dyskinetic Cerebral Palsy (DSP) confirmed by a pediatric neurologist
  • Being classified with a gross motor function level of IV-V using the Expanded and Revised Gross Motor Function Classification System (GMFCS E&R)
  • Having a Manual Ability Classification System (MACS) classification of manual ability level IV-V
  • Having a Communication Function Classification System (CFCS) communication function level of I-II-III
  • For volunteers participating through Zoom and Whatsapp applications, having computer literacy and these applications installed on their devices
  • e. Continuing routine physiotherapy and rehabilitation programs.

排除标准

  • Having difficulty understanding and following instructions
  • Having severe visual impairments
  • Having undergone orthopedic or brain surgery interventions in the last 12 months.

结局指标

主要结局

The Gross Motor Function Measure-88; The Gross Motor Function Measure-66

时间窗: Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention

The Gross Motor Function Measure-88 (GMFM-88) and its short form, the Gross Motor Function Measure-66( GMFM-66), assess gross motor function in children, especially those with cerebral palsy. KMFÖ-88 is widely used for comprehensive evaluations in clinical and research settings, whereas GMFM-66-66, a shorter version, focuses on activity measurement based on the International Classification of Functioning, Disability, and Health for Children and Youth (ICF-CY) to evaluate functional capacity in different positions and activities. A physiotherapist will conduct the assessment through clinical testing and video recordings will be independently evaluated by another researcher.

次要结局

  • Dyskinesia Impairment Scale(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Dyskinesia Impairment Mobility Scale(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Wong-Baker Faces Pain Rating Scale(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Dyskinetic Cerebral Palsy Functional Impact Scale(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Gross Motor Function Classification System(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Manual Ability Classification System(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Communication Function Classification System(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Eating and Drinking Classification System(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the interventione)
  • Visual Function Classification System(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Goal Attainment Scale(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Life-Habits Questionnaire(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • European Child Environment Questionnaire(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Parental Stress Scale(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)
  • Cerebral Palsy Quality of Life Questionnaire Child and Teen Palsy Quality of Life Questionnaire Child&Teen(Time frame1: baseline, pre-intervention; Time frame 2: immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mintaze Kerem Gunel

pt, PhD, prof.

Hacettepe University

研究点 (2)

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