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临床试验/NCT07374432
NCT07374432Enrolling By Invitation不适用

Full Speed Ahead: For Joyful Movement and Health

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
1
主要终点
Gross Motor Function MEasure (GMFM)

研究概览

简要总结

The aim of this project is to implement and evaluate the effects of a mobility-focused training program, including the use of running frames, on gross motor function and physical activity levels in children aged 2-5 years with cerebral palsy. The hypothesis is that these children can improve their mobility with or without assistive devices, that the training program will influence their overall activity level, and that it will provide cardiovascular exercise leading to improved fitness and muscle development.

In previous studies, the investigators have observed positive health-related outcomes in older children. Recently, three-wheeled Frame Running bikes designed for very young children have become available; however, no research has been conducted on these devices or their potential effects in toddlers.

In this project, group training sessions will be offered to children aged 2-5 years. Participants will receive mobility and gait training with or without assistive devices, depending on individual needs. The three-wheeled Frame Running bike will be included as one training component, although participants may use other assistive aids as needed. Training is planned as play-based activities together with peers, for one hour per week over a 12-week period, complemented by home-based exercises.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • severe intelectual disability

研究组 & 干预措施

intervention

Experimental

Frame running and gross motor training

干预措施: Full speed ahead (Behavioral)

结局指标

主要结局

Gross Motor Function MEasure (GMFM)

时间窗: From enrollment to the end of treatment at 3 month

Measure gross motor function in children with CP from 6 month to 18 years, the scale ranging from 0-100 units, higher is better

次要结局

  • Sens motion, Accelerometry(From enrollment to the end of intervention at 3 months)

研究者

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

Ann-Christin Eliasson

Professor, PhD

Karolinska Institutet

研究点 (1)

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