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Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study

Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy - A Pilot Study

Background:

- People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury) have shown that it is important to start intensive therapy soon after the injury, and it may be true that starting intensive therapy at a young age will be helpful for children with cerebral palsy. Researchers are interested in testing the effectiveness of a special body weight support system for mobility training in young children who have or are at risk for cerebral palsy.

Objectives:

- To study the effectiveness of a mobility training program on the motor skills of young children who have or are at risk for cerebral palsy.

Eligibility:

- Children between 12 and 36 months of age who have delayed motor skills and either have been diagnosed with cerebral palsy or show evidence of spasticity or brain damage.

Design:

  • This study involves two 6-week study phases: a baseline phase and a mobility training program.
  • Participants will be screened with a physical examination and medical history.
  • During the baseline phase, participants will have mobility testing sessions once every 2 weeks. These tests will measure motor development and ability, including ease and speed of walking.
  • Participants' parents/guardians will receive a mobility sensor for the child to wear at home for at least 6 hours (awake time) to measure activity and mobility levels outside of the testing sessions.
  • After 6 weeks of baseline testing, participants will have 6 weeks of mobility training for 30 minutes 3 days per week. Training will involve motor tasks with weight support, conducted by a pediatric physical therapist. Activities may include walking, climbing inclines or steps, or squatting to reach toys. All sessions will be videotaped.
  • To evaluate the effects of the therapy program, participants will have testing sessions every 2 weeks.
  • Parents/guardians will also complete questionnaires to provide feedback on the effectiveness of the therapy program.

研究概览

详细说明

The purpose of this pilot study is to test the feasibility and effects of a functional mobility training program on the motor ability and physical activity of young children who are developmentally delayed and at risk for cerebral palsy (CP). The study includes a sample of 10 participants between 12-36 months of age who have at least a 4 month motor delay and are at risk for CP in a single-subject research design with repeated measures during baseline and intervention phases. Participants will have biweekly assessments during the 6 week baseline phase and the subsequent 6 week mobility training phase, followed by a final assessment after 6 weeks of treatment withdraw. Assessments and training will occur in the Functional and Applied Biomechanics (FAB) section. The mobility training program consists of three days per week of 30 minute treatment sessions using dynamic body weight support during a variety of functional motor tasks. Children will be assisted, but not limited, by the dynamic weight support system while they are encouraged to participate in a variety of age-appropriate mobility tasks. It is hypothesized that this system combined with the functional activity practice will facilitate the development of postural control and strength, and thereby improve walking ability. The primary outcome measures are completion rate and gross motor ability as measured by the Gross Motor Function Measure (GMFM). Secondary outcome measures include the amount of gross motor delay as measured by the Bayley Motor Scale (BMS),, the Functional Mobility Scale (FMS), spatiotemporal gait measures, and amount of physical activity in daily life. Results of this pilot study will be used to refine the mobility training program, evaluate the appropriateness of the selected outcome measures, and to provide preliminary data for a larger scale clinical trial.

研究类型

介入性

注册 (实际的)

5

阶段

  • 阶段1

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。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

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

1年 至 3年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

    1. 12-36 months of age
    2. greater than or equal to 4 months of gross motor delay corrected for gestational age (measured by Bayley Motor Scale)
    3. Diagnosis of bilateral spastic cerebral palsy OR neurological evidence of spasticity or brain damage
    4. Ability to pull to stand at a surface without assistance
    5. Cognitive ability to follow one-step commands
    6. Availability to return to NIH CC with parent or caregiver for required treatment and assessment sessions

EXCLUSION CRITERIA:

  1. Unilateral cerebral palsy
  2. Secondary orthopedic, neuromuscular or cardiovascular condition unrelated to CP
  3. Greater than six months of independent walking experience
  4. History of surgery or injury to the lower extremities in the past 6 months

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:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
Change in motor delay

次要结果测量

结果测量
Completion rate, change in gross motor function, change in functional mobility, change in walking speed, change in physical activity

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2010年11月15日

初级完成 (实际的)

2014年6月6日

研究完成 (实际的)

2014年6月6日

研究注册日期

首次提交

2010年12月2日

首先提交符合 QC 标准的

2010年12月2日

首次发布 (估计)

2010年12月3日

研究记录更新

最后更新发布 (实际的)

2019年12月17日

上次提交的符合 QC 标准的更新

2019年12月14日

最后验证

2016年4月14日

更多信息

与本研究相关的术语

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.

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