'FRAME-EX´ - FRAME Running for EXercise in Children and Young People With Disabilities - a Study Protocol for a Quasi-Experimental Single-Arm Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Children's Functional Mobility Measured by the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) From Baseline to Week 12 and Week 24.
研究概览
简要总结
The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical disabilities. The study includes participants aged 8-18 years with cerebral palsy or other conditions causing physical disabilities.
The aim of the study is to investigate changes in the primary outcome measure; functional ability using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), and a series of secondary outcome measures on mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life in children and young people with physical disabilities.
Participants will complete a 24-week training program carried out in community athletics clubs:
12-week low-intensity control period with one supervised weekly Frame Running session focused on familiarization.
12-week moderate-to-high intensity intervention period with two weekly training sessions, including warm-up, technique training, endurance and speed intervals, and participation-focused activities.
Data collection comprises four standardized questionnaires, four physical performance tests conducted at multiple time points, an electronic training diary, and Rating of Perceived Exertion-Pediatric Scale (RPE-P) obtained before and after selected endurance tests.
详细描述
The full protocol detailing all study procedures and methodology is available under Study Documents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 8-18 years.
- •Diagnosed with cerebral palsy (CP) or another condition resulting in a physical disability affecting mobility.
- •Some prior Frame Running experience, such as informal use or occasional training, but must not have taken part in structured, organized, or performance-oriented Frame Running training within the past 12 weeks.
- •Able to propel the Frame Running bike forward independently
- •Able to understand and follow instructions related to Frame Running activities.
排除标准
- •Severe visual and/or cognitive impairments that would compromise safe participation
- •Known medical conditions that could limit or contraindicate involvement in the study (e.g., significant cardiovascular or pulmonary disease).
研究组 & 干预措施
Frame Running Training Program
Participants receive a structured Frame Running training program delivered in community athletics clubs. The program includes a 12-week low-intensity phase with one supervised session per week, followed by a 12-week moderate-to-high intensity phase with two weekly sessions.
干预措施: Frame Running Training (Behavioral)
结局指标
主要结局
Change in Children's Functional Mobility Measured by the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) From Baseline to Week 12 and Week 24.
时间窗: Baseline, Week 12, and Week 24
Functional mobility will be assessed using the Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Mobility domain. The PEDI-CAT Mobility domain provides a scaled score ranging from 20 to 80, with higher scores indicating better functional mobility.
次要结局
- Change in Endurance Measured by the 6-Minute Frame Running Test From Baseline to Week 12 and Week 24(Baseline, Week 12, and Week 24)
- Change in running speed measured by the 10-Meter Frame Running Sprint Test (Seconds) from Baseline to Week 12 and Week 24.(Baseline, Week 12, and Week 24)
- Change in Functional Strength Measured by the 1-Minute Sit-to-Stand Test From Baseline to Week 12 and Week 24.(Baseline, Week 12, and Week 24)
- Change in Walking Capacity Measured by the 1-Minute Walk Test From Baseline to Week 12 and Week 24(Baseline, Week 12, and Week 24)
- Change in Functional Performance Measured by the Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Daily Activities, Social/Cognitive, and Responsibility Domains Scaled Scores from Baseline to Week 12 and Week 24(Baseline, Week 12, and Week 24)
- Change in Health-Related Quality of Life Measured by the Pediatric Quality of Life Inventory (PedsQL) From Baseline to Week 12 and Week 24.(Baseline, Week 12, and Week 24)
- Change in Participation Diversity and Intensity Measured by the Children's Assessment of Participation and Enjoyment / Preferences for Activities of Children (CAPE-PAC) from Baseline To Week 12 and Week 24(Baseline, Week 12, and Week 24)