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临床试验/NCT06800014
NCT06800014已完成不适用

Investigation of the Effectiveness of Wearable Activity Trackers and Mobile Application-Supported Telerehabilitation in Individuals With Cerebral Palsy

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024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
Physical Activity Questionnaire for Adolescents

研究概览

简要总结

The inadequate number of rehabilitation sessions and the difficulties in accessing rehabilitation services for people with cerebral palsy result in delayed progress and low levels of physical activity for these people. As a result, it is well known that daily life often hinders the implementation of prescribed home programmes, leading to neglect. In the rehabilitation of people with cerebral palsy, physiotherapists face difficulties in monitoring patients and ensuring compliance with home exercise programmes. Both people with cerebral palsy and their carers often experience dissatisfaction and lack of motivation regarding the monitoring and control of development and activity.

This study aims to evaluate the effectiveness of a telerehabilitation programme supported by a mobile application and a wearable activity tracker, in addition to a standard rehabilitation programme, on physical activity levels, quality of life, sleep quality, balance, activity participation and motivation, and patient satisfaction in people with cerebral palsy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Aged between 14 and 18 years old
  • •Diagnosed with cerebral palsy
  • •Currently enrolled in a regular rehabilitation programme
  • •Level 1-3 according to Gross Motor Function Classification System (GMFCS)
  • •No cognitive impairments affecting the understanding of exercise programmes
  • •Voluntary informed consent to participate
  • •No recent surgeries (e.g. botox, muscle relaxation) within the past 6 months
  • •No socioeconomic issues related to the use of smart devices

排除标准

  • •The impact of recent surgical procedures or medical interventions on physical performance.
  • •The influence of health conditions that affect the entire body and physical performance.

研究组 & 干预措施

Telerehabilitation

Experimental

干预措施: Telerehabilitation (Other)

Control

Experimental

干预措施: Conventional exercise (Other)

结局指标

主要结局

Physical Activity Questionnaire for Adolescents

时间窗: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.

The PAQ-A was developed by Kowalski et al. in 1997 to assess physical activity levels in adolescents (Kowalski et al., 2004). It is suitable for the 14-20 age group. The questionnaire consists of nine questions and assesses physical activity levels over the past seven days. The Turkish validity and reliability study was conducted in 2017. PAQ-A contains eight questions scored between 1 and 5, with a ninth question asking about any condition that might have prevented physical activity during the past week. A score of "1" indicates low-intensity physical activity, while "5" indicates high-intensity physical activity. The ninth question is not included in the scoring. The total score is calculated by averaging the scores of all questions (Aygün Polat, 2017).

Physical Activity Enjoyment Scale

时间窗: Prior to the commencement of the study and following a period of six weeks from the initiation of the application.

The PAES is a satisfaction scale developed by Mullen et al., consisting of eight items rated on a 7-point Likert scale (Mullen, 2011). The Turkish validity and reliability study was conducted by Bozkurt et al. (Bozkurt et al., 2022).

次要结局

  • Cerebral Palsy Quality of Life Questionnaire for Teen(Prior to the commencement of the study and following a period of six weeks from the initiation of the application.)
  • Pittsburgh Sleep Quality Index(Prior to the commencement of the study and following a period of six weeks from the initiation of the application.)
  • Trunk Control Measurement Scale(Prior to the commencement of the study and following a period of six weeks from the initiation of the application.)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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