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Acceptability and Efficacy of GO MOVE 50 运动

招募中
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临床试验NCT06048419是一项针对脑瘫,半身不遂型脑瘫干预性研究试验,目前试验状态为招募中。试验始于2024年2月20日,计划招募50名患者。该研究由Texas Scottish Rite Hospital for Children主导,预计于2026年12月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年3月10日
简要概括

The goal of this clinical trial is to learn about the acceptability and efficacy of Go Move, a mobile website developed to assist youth with unilateral cerebral palsy and their caregivers with setting goals and selecting exercises and activities to meet the goals. The main question\[s\] it aims to answer are:

  • Is Go Move accepted by youth with unilateral cerebral palsy and their caregivers?
  • Does Go Move support g...
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官方标题

Acceptability and Efficacy of GO MOVE: A Mobile Health Technology for Youth With Unilateral Cerebral Palsy

疾病
脑瘫半身不遂型脑瘫
其他研究标识符
  • STU-2023-0531
NCT编号
实际开始日期
2024-02-20
最近更新发布
2025-03-10
预计完成日期
2026-12
计划入组人数
50
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
home program
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Go Move Home Program
Goal driven home program
Home Program
Home program for 6 weeks (1 hr and 15 minutes per week)
主要终点
结果指标度量标准描述时间框架
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure is a criterion referenced, individualized, client-centered outcome measure designed for use by occupational therapists to detect change in a client's self-perception of occupational performance over time on a scale of 1-10 (1 being the lowest)
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
次要终点
结果指标度量标准描述时间框架
Goal Attainment Scale (GAS) Light
The Goal Attainment Scale is an individualized, functional outcome measure involving goal selection and scaling. The scale ranges from -2 to +2 with -2 representing a decline in function, -1 no change, 0 expected outcome, +1 a little more, +2 a lot more.
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Assisting Hand Assessment (AHA) (optional)
The Assisting Hand Assessment is a criterion referenced, valid and reliable 22-item measure that assesses the assisting or affected hand in carrying out bimanual activities for children with cerebral palsy or obstetric brachial plexus palsy measured by AHA units on a scale of 0-100 with 0 being the lowest level of function.
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
3 Years
适龄性别
全部
  • Inclusion criteria for participants to enroll in the study include a diagnosis of unilateral CP or a non-progressive brain lesion, injury, or trauma of the developing brain that presents with a unilateral upper limb motor impairment. GMFCS levels 1 or 2. MACS levels 1-3. Age 3-17 years old, ability to follow directions, ability to complete the assessment protocol, and the ability to access the GO MOVE webpage on a personal device. All ethnic/racial groups will be eligible to participate. The ability to participate in everyday activities without restriction from a physician throughout the duration of their participation in the study (does not have restrictions/contraindications following a medical procedure).

  • The study will exclude any patients with uncontrolled epilepsy or significant visual impairment. The study will exclude any patient with severe behavioral problems or the inability to complete the assessment protocol or home program.
Texas Scottish Rite Hospital for Children logoTexas Scottish Rite Hospital for Children
研究责任方
Angela Shierk, 主要研究者, Clinical Scientist, Texas Scottish Rite Hospital for Children
研究中心联系人
联系人: Angela Shierk, PhD, 4694127172, [email protected]
联系人: Heather Roberts, PhD, 214-794-8117, [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