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临床试验/NCT06591559
NCT06591559已完成不适用

Up, Down, and All Around: Evaluating Mobility Devices for Young Children With Developmental Disabilities and Delays

University of Washington1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Percentage of space explored

研究概览

简要总结

This research study will examine young children with Down syndrome's initial experiences with mobility devices. Children's biomechanics and exploration will be quantified while they are using both an overground partial bodyweight support system and powered mobility device.

详细描述

Young children with Down syndrome experience delays in cognition, communication, and mobility. As a result of cerebellar hypoplasia, children with Down syndrome have altered balance and coordination, muscle hypotonia, decreased muscle strength, and ligament laxity. Low muscle tone and ligament laxity can lead to the adoption of unfavorable postures, putting children at risk for developing musculoskeletal disorders in the future.

While children with Down syndrome are expected to walk, they do so significantly later than their peers, creating a gap in mobility, exploration, and socialization in the first years of life. Mobility during the first years is crucial to facilitate cascades of reciprocal development in cognition, communication, and motor skills, as well as reduce developmental delays and participation disparities for children with Down syndrome compared to their peers. While early intervention is common during this time to facilitate movement, clinical practice patterns vary widely and there are few evidence-based interventions or assistive technologies to support children and their families.

Treadmill training is currently the only intervention that has demonstrated efficacy for young children with hypotonia, but only for improving walking speed among already ambulatory children. Traditional treadmill training is limited, however, in that it does not allow for the sensorimotor experiences and social interactions that occur with self-initiated mobility in enriched, and often unpredictable, natural environments. As such, treadmill training and other clinical interventions may not fully address the need for holistic and multi-modal mobility opportunities.

Augmented mobility - in the form of partial bodyweight support systems, gait trainers, and powered mobility - has been proposed as a promising and complementary intervention to support early development in Down syndrome. While these tools have the potential to bridge the gap in self-initiated mobility and accelerate the onset of independent walking, little is scientifically known about how children engage with these devices nor how these devices shape their interactions with their environment. Furthermore, there is a lack of knowledge concerning the impact of different mobility devices on a child's physical development and posture.

In this research, the investigators propose to quantify a child's exploration, posture, and motor control strategies while using two promising assistive technologies for pre-ambulatory young children with Down syndrome: a partial-bodyweight support system (PUMA, Enliten, LLC.) and a powered mobility device (Explorer Mini, Permobil) that can be used in both seated and standing postures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
12 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • are able to sit upright independently
  • are able to tolerate moving through space while upright for 30 minutes
  • are under 35 pounds in weight
  • are under 39 inches tall in height
  • developmental delays and conditions that affect mobility and muscle tone

排除标准

  • - are able to walk 10 ft independently

研究组 & 干预措施

No Device

No Intervention

Children will play for 30 minutes using no mobility device.

Explorer Mini in a Seated Posture

Active Comparator

Children will play for 30 minutes using the Explorer Mini a seated posture.

干预措施: Permobil Explorer Mini (Device)

Explorer Mini in a Standing Posture

Active Comparator

Children will play for 30 minutes using the Explorer Mini a standing posture.

干预措施: Permobil Explorer Mini (Device)

Portable Mobility Aid Partial Body Weight Support Harness (PUMA)

Active Comparator

Children will play for 30 minutes with partial bodyweight support provided by the PUMA.

干预措施: Portable Mobility Aid for Children (PUMA) (Device)

结局指标

主要结局

Percentage of space explored

时间窗: At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)

The path of each child's movement during the play sessions will be tracked from video recordings and sensor data. The path will then be used to determine the percentage of the available play space that the child explored. Values will range from 0 - 100%, a higher value indicates more space explored.

次要结局

  • Normalized Integrated Electromyography (EMG)(At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4))
  • Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.1: Children Version(At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Feldner

Assistant Professor, School of Medicine

University of Washington

研究点 (1)

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