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临床试验 NCT06100562 针对脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Dance Program for Youth With Cerebral Palsy 20 适应性设计
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临床试验NCT06100562是一项针对脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2024年1月22日，计划招募20名患者。该研究由Texas Scottish Rite Hospital for Children主导，预计于2027年8月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月8日。
简要概括
The goal of this prospective cohort study is to learn about the impact of an adapted dance program in youth with cerebral palsy. The main questions it aims to answer are:
- Are there clinically significant benefits for children with cerebral palsy who participate in an Adaptive Dance Program?
- Is it feasible to implement an adaptive dance program using action-observation principles for children diagnosed with Cer...
详细描述
Purpose:
Cerebral palsy (CP) is defined as a group of permanent disorders of the development of movement and posture that are attributed to non-progressive disturbances which occurred in the developing fetal or infant brain. As children with CP experience development and growth, motor disorders present along with disorders related to sensation, perception, cognition, and/or a seizure disorder. The way that CP manife...
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Dance Program for Youth With Cerebral Palsy
疾病
脑瘫出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- STU-2023-0893
NCT编号
实际开始日期
2024-01-22
最近更新发布
2025-09-08
预计完成日期
2027-08
计划入组人数
20
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Dance
Action Observation
Action Observation
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Dance Program 10-week adapted dance program (20 hours) | Adapted Dance Program * Participants will attend a 2x/weekly adaptive dance session for 10 weeks. If participants miss a class due to illness or an unexpected event (loss of transportation, family emergency/need) they will receive a video of the content missed and can complete the session at home.
* Each class will start with a 10 min warm-up that will include stretching and motor games.
* Learn a section of choreography every session usi...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Pediatric Balance Scale (PBS) | a 14-item criterion referenced measure that tests functional balance for pediatric patients in everyday tasks with a sum score of 0-56. A higher score represents better balance. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
6 minute walk test (6MWT) | a standardized, self-paced walking test that is used to measure functional ability; the score is the amount of meters walked in 6 minutes; longer distances walked represents better function | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
The Cerebral Palsy Quality of Life Questionnaire (CPQOL) | a standardized patient reported outcome measure that measures quality of life; it is completed by the caregiver and by children with CP ages 9+; each item is rated on a scale from 1-9, higher ratings indicate better quality of life | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Child and Adolescent Scale of Participation (CASP) | 20-item caregiver questionnaire that measures a child or adolescent's participation in home, school, and community with a sum score of 20-80; a higher score represents higher participation | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Modified Ashworth Scale (MAS) | standardized measurement of tone on a 5 point scale (0, 1, 1+, 2, 3); a higher score represents increased tone | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Quality of Upper Limb Extremity Skills Test (QUEST) (optional) | standardized, criterion-referenced assessment that measures dissociated movement, grasp, protective extension, and weight bearing that is reported using a standard score ranging from 0-100. A higher score represents better upper limb function. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) -subsections (bilateral coordination and upper limb coordination) (optional) | standardized, norm-referenced assessment that measures fine and gross motor skills; subtests are scored using scaled scores with a mean of 15 and standard deviation of 5. A higher score represents higher motor performance. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
4 Years
适龄性别
全部
- Diagnosis of cerebral palsy
- GMFCS levels 1 or 2
- MACS levels 1-3
- Aged 4-17 years
- Able to follow directions in English
- Ability to complete the assessment protocol
- Does not have any restrictions/contraindications following a medical procedure that prohibits movement
- has uncontrolled epilepsy
- has severe behavioral problems
- unable to complete the assessment protocol
Texas Scottish Rite Hospital for Children研究中心联系人
联系人: Angela Shierk, PhD, (469) 412-7172, [email protected]
1 位于 1 个国家/地区的研究中心
Texas
Scottish Rite for Children, Frisco, Texas, 75034, United States
Angela Shierk, PhD, 联系人, 469-412-7172, [email protected]
招募中