Evaluating Adaptive Rock Climbing on Children with Upper Limb Differences
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline in PROMIS Pediatric Global Health Scores at 12 Weeks
研究概览
简要总结
The goal of this clinical trial is to assess changes in functional and psychosocial outcomes following a 12-week adaptive rock-climbing program for children with congenital upper limb differences. The main questions it aims to answer are
- Assess functional outcomes following a 12-week adaptive rock-climbing program.
- Assess psychosocial outcomes following a 12-week adaptive rock climbing program.
- Assess barriers to participation in adaptive sports.
Participants will complete 12-week adaptive rock climbing program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents 18 years and older.
- •English or Spanish speaking.
- •Participants with unilateral or bilateral congenital upper extremity disorders of limb formation differences ages 6-16.
排除标准
- •Any patients younger than 6 years or older than 16 years, patients not fluent in English or Spanish, or patients with parents younger than 18 years.
结局指标
主要结局
Change from Baseline in PROMIS Pediatric Global Health Scores at 12 Weeks
时间窗: Baseline and 12 weeks
To gain a general view of participants' perception of their own physical, emotional, and relational health, children will also be asked to complete the PROMIS Pediatric Global Health v1.0 7-item Short Form. Participants will respond to 7 statements on a scale of 5 "Excellent" to 1 "Poor."
Change from Baseline in KINDL Scores at 12 Weeks
时间窗: Baseline and 12 weeks
The KINDL questionnaire will be completed by both child and parent. It includes 24 Likert-scaled items associated with emotional well-being and self-esteem. Questionnaires will be scored according to instructions provided by KINDL.
Change from Baseline in Muscle Testing at 12 Weeks.
时间窗: Baseline and 12 weeks
Manual muscle testing will be measured by an occupational therapist. This will be measured from grade 0 to 5.
Change from Baseline in Range of Motion at 12 Weeks
时间窗: Baseline and 12 weeks
An occupational therapist will measure the passive and active range of motion. These measurements will be conducted for the following: shoulder flexion, shoulder abduction, shoulder internal rotation, shoulder external rotation, elbow flexion/extension, forearm supination, forearm pronation, wrist extension, and wrist flexion. This will be measured in degrees.
Change from Baseline in PROMIS Life Satisfaction Scores at 12 Weeks.
时间窗: Baseline and 12 weeks
To assess positive affect and well-being, children and parents will complete the PROMIS Pediatric Life Satisfactions v1.0 8-item Short Form. Patients will respond to statements such as "I was satisfied with my life," on a scale of 1 "Not at all" to 5 "Very much."
次要结局
- Assess Barriers to Participation in Adaptive Sports(At 12 weeks (post-intervention))
研究者
Nina Lightdale
Principal Investigator
Children's Hospital Los Angeles