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临床试验/NCT06866353
NCT06866353已完成不适用

Impacts on Quality of Ambulation Using Various Assistive Devices for Patients With Cerebellar Ataxia

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家实际入组 20 人开始时间: 2025年5月22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
20
试验地点
1
主要终点
Zeno Walkway - Gait Speed

研究概览

简要总结

The purpose of this research study is to determine the effect of various assistive devices on gait quality and balance for individuals with cerebellar ataxia. You are being asked to be a participant in this study because your balance and walking function have been impacted by cerebellar ataxia.

详细描述

The literature for cerebellar ataxia does not encompass specific details on selecting assistive devices. Studies do indicate that providing assistive devices for trunk support may improve gait and stability in individuals with ataxia. However, there is no consensus on assistive device selection. In general, falls and instability are one of the primary factors impacting independence, safety, and functional mobility. Additionally, early literature has indicated that external cues may be very beneficial for gait in individuals with ataxia.

No focal literature on what device is best but many articles suggest using them

  • Trunk instability = gait variability, wider BOS with walker is beneficial (Buckley, 2018; Kelly, 2016)
  • Choosing the correct walking aid is important, canes to walkers and those with a heavy base to prevent retropulsion as well as all-terrain walkers (Stephen, 2019) Additionally, aerobic, balance, core/strengthening, gait interventions are utilized via physical therapy.

研究设计

研究类型
干预性
分配方式
不适用
干预模型
单组
主要目的
治疗
盲法
开放(无盲法)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • Cerebellar ataxia,
  • gait impairment (gait velocity </= 110 cm/sec without an assistive device),
  • ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s), 18 years or older

排除标准

  • Gait velocity >/= 110 cm/sec without an assistive device,
  • Medically diagnosed orthopedic conditions or injuries that impact ambulation

研究组 & 干预措施

Gait with Walker

Experimental

Individuals with ataxia

干预措施: Walking with different walkers (Device)

结局指标

主要结局

Zeno Walkway - Gait Speed

时间窗: Day one

The Zeno provides kinematic gait information including gait velocity.

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Staci Shearin

Associate Professor

University of Texas Southwestern Medical Center

研究点 (1)

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标识符

NCT 编号
NCT06866353
其他研究编号
STU20250055

日期

首次提交
(去年)
首次发布
(去年)
主要完成日期
(去年)
研究完成日期
(去年)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
是
个体参与者数据共享计划
否
是否有结果
是

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