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临床试验/NCT06402799
NCT06402799已完成不适用

Research Protocol for Feasibility Testing of 12 Weeks Home-based E-biking Intervention Among Individuals With Cerebral Palsy

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Feasibility of study assessed by minimum 70% participation in planned training volume among participants

研究概览

简要总结

Investigation of the feasibility of virtually group-based e-biking training at home. Individuals aged 13-60 years with CP (Cerebral Palsy) with a Gross Motor Function Classification System score of 1-3 were recruited for a 12-week home-based e-biking training program.

详细描述

All participants should be able to use a touchscreen, as this type of technology is used in the virtual e-biking training. Participants complete a questionnaire and subsequently engage in 12 weeks of home-based virtual e-biking training. A loaned bicycle will be provided for the training period and set up in the participants' own homes. Setup and adjustments will be performed by trained healthcare personnel. The following measurements will be taken before and after the training period: weight, height, hip-waist measurements, blood pressure, a 30-second sit-to-stand test, a timed-up-and-go test, ankle measurements, and a functional threshold power test (FTP). Seven accelerometers will be attached to the right and left arms, thighs, lower legs, and sternum using NJaP patches and worn for 72 hours at the beginning and end of the training period. The accelerometers can be easily removed after 72 hours.

The e-biking intervention consists of 3 sessions per week at the beginning of the study and gradually increases over the training period to 6 sessions per week, with three of these sessions being online and group-supervised.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with cerebral palsy (GMFCS 1-3)
  • Are able to keep balance on a stationary bike
  • Are able to use a touchscreen

排除标准

  • 未提供

结局指标

主要结局

Feasibility of study assessed by minimum 70% participation in planned training volume among participants

时间窗: At the end of the study (after 12 weeks of e-biking training)

Number of participants who complete the study successfully assessed by percentage of completed planned training volume

次要结局

  • Change in the 30-seconds sit-to-stand test(At the end of the study (after 12 weeks of e-biking training))
  • Change in FTP test among participants(At the end of the study (after 12 weeks of e-biking training))
  • Change in timed-up-and-go test(At the end of the study (after 12 weeks of e-biking training))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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