Home and Community Use of a Suspension Walker in Pre-Walking Infants With Down Syndrome
2026年6月2日 更新者：Kari Kretch、University of Southern California
Feasibility of a Novel Overground Stepping Intervention for Pre-Walking Infants With Down Syndrome
The goal of this clinical trial is to learn if pre-walking infants with Down syndrome can use a suspension walker in their home and community environments. The main questions it aims to answer are:
- Is suspension walker intervention feasible for pre-walking infants with Down syndrome?
- What are barriers to successfully using suspension walkers in home and community environments?
- What are facilitators for successfully using suspension walkers in home and community environments?
Participants will:
- Use a suspension walker in the home and community for a three-month period (goal 20 minutes/day, 5 days/week)
- Meet with a therapist three times in their home to learn how to use the walker
- Track how often they use the walker for one week each month
- Complete assessments of infants' gross motor skill and ability to use the walker before and after the three-month period
- Be interviewed after the three-month period about their experiences using the walker
研究概览
研究类型
介入性
注册 (估计的)
12
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kari S Kretch
- 电话号码：323-442-3364
- 邮箱：kretch@usc.edu
研究联系人备份
- 姓名：Learning, Development, and Rehabilitation Lab
- 电话号码：(323) 442-3119
- 邮箱：learninglab@usc.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- Diagnosis of Down syndrome
- 10-13 months of age
- Able to sit independently
- Unable to walk independently
Exclusion Criteria:
- Medical or orthopedic conditions other than Down syndrome that prevent standing or walking
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：walker intervention
|
Parents will be provided with a pediatric suspension walker and instructed to use the walker with their infant at least 20 total min/day, 5 days/week.
Parents will be instructed in 3 activity types: 1) Adult-propelled stepping consists of the caregiver moving the walker along the floor to prompt the infant to step.
2) Self-propelled walking consists of encouraging the infant to step independently to propel the walker, with intermittent assistance from the caregiver as needed.
3) Play consists of a variety of mobile and stationary play activities, adapted to the child's interests, engaged in while supported in the walker.
Parents will brainstorm with the therapist to select play activities and to determine where and when to perform stepping and walking activities.
This may include home- and community-based locations, including larger rooms in the home, hallways, sidewalks, parks, and indoor community spaces like supermarkets or shopping malls.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
participation in instructed dosage
大体时间：first week of each month for three months
|
Dichotomous: Was the family able to use the walker for the instructed 20 minutes/day, 5 days/week?
|
first week of each month for three months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
usage frequency and duration
大体时间：first week of each month for three months
|
minutes per day, days per week
|
first week of each month for three months
|
|
steps per minute
大体时间：first week of each month for three months
|
steps per minute while using walker (measured by StepWatch step counters)
|
first week of each month for three months
|
|
gross motor function
大体时间：0 and 3 months
|
Gross Motor Function Measure-88
|
0 and 3 months
|
|
stepping ability
大体时间：0 and 3 months
|
rate of alternating steps while the walker is moved by an adult
|
0 and 3 months
|
|
walker propulsion
大体时间：0 and 3 months
|
Dichotomous: Was the infant able to propel the walker without assistance?
|
0 and 3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kari S Kretch, PT, DPT, PhD、University of Southern California
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2028年8月1日
研究注册日期
首次提交
2026年5月28日
首先提交符合 QC 标准的
2026年6月2日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年6月5日
上次提交的符合 QC 标准的更新
2026年6月2日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 26-02380
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
all non-identifiable IPD
IPD 共享时间框架
at the time of publication of results
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.