Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
研究概览
简要总结
The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.
详细描述
This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 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
- •Between the ages of 50 and 75
- •Ability to walk 150 feet independently over level surfaces with or without an assistive device
- •Stable medication usage for the duration of the study (10 weeks)
- •Obvious gait dysfunction (Observational Gait Analysis)
- •Score of greater than 22 on the Short Orientation-Memory-Concentration Test
排除标准
- •Body mass index of greater than 35
- •Dorsiflexion range of motion less than neutral (90 degrees)
- •Any other uncontrolled health condition for which gait training is contraindicated
结局指标
主要结局
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
时间窗: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment
Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
次要结局
- Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing(Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.)
研究者
Karen McCain
Assistant Professor
University of Texas Southwestern Medical Center