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临床试验 NCT06852664 (Fitbit) 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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Improving Activity in Individuals With Cerebral Palsy (Fitbit) 32 可穿戴设备
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临床试验NCT06852664 (Fitbit)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2025年3月1日，计划招募32名患者。该研究由Father Flanagan's Boys' Home主导，预计于2029年3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29日。
简要概括
Individuals with cerebral palsy are known to have a reduced amount of physical activity; yet, there are no known intervention strategies for improving the number of steps they take each day. This study will use wearable physical activity monitors to assess if behavioral coaching is a viable strategy for combating the reduced physical activity seen in this patient population.
详细描述
A lack of physical activity in persons with cerebral palsy is known to have cascading effects on their overall health. Despite this recognition, there have been limited attempts to improve the physical activity of this patient population. The overall landscape of this project is that a cohort of persons with cerebral palsy will undergo 8 weeks of physical activity that is guided by behavioral coaching. This study aim...显示更多
官方标题
Improving Activity in Individuals With Cerebral Palsy
疾病
脑瘫其他研究标识符
- Fitbit
- 24-23-XP
NCT编号
实际开始日期
2025-03-01
最近更新发布
2025-09-29
预计完成日期
2029-03-01
计划入组人数
32
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
Cerebral Palsy
Fitbit
Mobility
Steps
Fitbit
Mobility
Steps
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Cerebral Palsy Youth/Young Adults Baseline and 8-week assessments as well as 8 weeks of motivational interviewing 3x/week | 动机访谈 The participants will meet with the research staff three times a week during the eight weeks of wearing the activity monitor via video or Webex call with a duration ideally not exceeding one hour. All staff involved in these coaching sessions have been MINT trained and certified and have mastered the skills of motivational interviewing. Their goal will be to discuss with the participant about how successful they have...显示更多 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in Mobility Test Time | The participant will be asked to perform a series of 10-meter walking tasks such as walking at preferred speed, walking as fast as possible, walking while turning the head, walking around cones, and stepping over a box. The participant will also be asked to walk as far as possible for 1 minute. Completion time will be the primary outcome for these tests. Additionally, the tests will also be digitally video-recorded and scored by an independent assessor. | Baseline and 8 weeks |
Change in Time in 5 Times Sit-to-Stand | The participant will start the test by sitting on a bench. The time it takes to stand up and sit down five times will be the outcome measure. | Baseline and 8 weeks |
Change in Time for Timed Up and Go | The participant will start the test by sitting on a bench. The time it takes the participant to stand-up, walk to a line on the floor that is 3-meters away and return to sitting on the bench will be the outcome measure. | Baseline and 8 weeks |
Changes in Brain Activity | Magnetoencephalography (MEG) will be used to assess the changes in the cortical activity while producing a leg motor action and processing peripheral sensations. | Baseline and 8 weeks |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
11 Years
适龄性别
全部
- Cerebral palsy diagnosis and ambulatory (Gross Motor Function Classification Score \[GMFCS\] levels between I-III).
- No orthopedic surgery in the last 6 months, botulinum injections within the last 6 months, or metal in their body that would preclude the use of MEG.
Father Flanagan's Boys' Home研究责任方
Max Kurz, 主要研究者, Director of PoWER Lab, Father Flanagan's Boys' Home
研究中心联系人
联系人: Max J Kurz, PhD, 531-355-8924, [email protected]
联系人: Jennifer M Kime, MS, 531-355-8959, [email protected]
1 位于 1 个国家/地区的研究中心
Nebraska
Boys Town National Research Hospital, Boys Town, Nebraska, 68010, United States
Max J Kurz, PhD, 联系人, 402-559-6415, [email protected]
Max J Kurz, PhD, 主要研究者
招募中