The Long Term Impact of Walking Practice on Functional Mobility and Quality of Life in Persons With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in Distance Walked on 6-Minute Walk Test (6MWT)
研究概览
简要总结
The purpose of this study is to investigate the impact of a specifically designed leg brace on walking endurance in individuals with Parkinson's disease.
详细描述
This is a randomized, repeated measures, matched group study. There will be three groups of participants, 20 participants per group, 60 participants total. Group one (G1) will receive custom-fabricated bilateral braces and a standardized home walking/exercise program. Group two (G2) will receive an off-the shelf ankle support and standardized home walking/exercise program. Group three (G3) will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. Subjects will be followed for one year during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 6 months for the duration of the study for testing as well as for other visits as noted in the table below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
- •Age between 30 and
- •Ability to walk 150 feet independently over level surfaces with or without an assistive device.
- •Hoehn and Yahr stage 1-
- •Less than 10 full heel raises in single limb stance bilaterally.
- •Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.
排除标准
- •Body mass index greater than
- •Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
- •Any other uncontrolled health condition for which gait training is contraindicated
结局指标
主要结局
Change in Distance Walked on 6-Minute Walk Test (6MWT)
时间窗: 6MWT will be done at initial testing and 12 months
Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
次要结局
- Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System(Testing will be done at initial testing and 12 months)
研究者
Karen McCain
Associate Professor
University of Texas Southwestern Medical Center