The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Walking Distance During 6-Minute Walk Test
研究概览
简要总结
The purpose of this study is to investigate the impact of ankle foot orthoses (AFOs) on the spatial and temporal gait parameters, electromyography (EMG), walking endurance, and quality of life in select individuals living with MS. The hypotheses of the study are: 1. Individuals who are fit with an AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with an AFO will demonstrate improvements in walking endurance. 3. Individuals who are fit with an AFO will demonstrate improvements in muscle firing profiles/EMG measures. 4. Individuals who are fit with an AFO will demonstrate improvements in quality of life.
详细描述
This is a non-randomized, single group (N=15), repeated measures study. The outcome measure for the study include: 1. GAITRite System for step length, 2. EMG of the anterior tibialis, gastrocnemius, soleus, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. 12-Item MS Walking Scale (Quality of Life assessment). This study will be 24 weeks long. Over the 24-week period, the subject will participate in 14 gait training sessions which will be at weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 17, 20 and 23. The treatments will be 45-60 minutes in duration. Outcome measures (all or part) will be assessed at the following times: initial (T1), week 5 (T2), week 13 (T3), and week 24 (T4). Subjects will be closely monitored throughout the 24 week study and will be un-enrolled by self-request or the following medical reasons: 1. Acute exacerbation of MS symptoms, 2. New diagnosis with direct consequences affecting gait training, 3. Inability to tolerate the AFO.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a primary diagnosis of multiple sclerosis
- •Individuals who are able to maintain a walking velocity of 30 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
- •Could have current or past history of single or bilateral AFO use, including neuroprostheses
- •Evidence of weakness in plantarflexors
排除标准
- •The presence of co-morbidities (neuromuscular or musculoskeletal) that would negatively impact gait training
- •Individuals with BMI with >/= 40kg/m2
- •Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
- •Individuals that plan to begin the use of Ampyra during the course of the study
- •Individuals for whom the cost of an orthosis would represent a financial burden
- •Individuals who are receiving concurrent physical therapy services elsewhere
- •MSNQ of >22
结局指标
主要结局
Change in Walking Distance During 6-Minute Walk Test
时间窗: Assessed at visit 2 (week 1) and week 24
Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.
次要结局
- Change in Impact of MS on Fatigue Using the 12-Item Walk Scale(Assessed at visit 2 (week 1) and week 24)
- Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)(Assessed at visit 2 (week 1) and week 24)
- Change in Step Length Using the GAITRite Computerized Gait Analysis System(Assessed at visit 2 (week 1) and week 24)
研究者
Karen McCain
Associate Professor, School of Health Professions
University of Texas Southwestern Medical Center