The Impact of Ankle Foot Orthosis (AFO) on Gait Recovery in Select Individuals With Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Step Length From Initial Testing to End of Study
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 MS. This orthotic is fabricated to allow ankle range of motion required for normal gait kinematics. Additionally, it controls forward progression of the tibia during the stance phase of gait. This study has three hypotheses 1. Individuals who are fit with the AFO will demonstrate improvements in spatial and temporal gait parameters 2. Individuals who are fit with the AFO will demonstrate improvements in walking endurance, and 3. Individuals who are fit with the AFO will demonstrate improvements in muscle firing profiles/EMG measures.
详细描述
This is a non-randomized, single group (N=15), repeated measures study. The study will take place at the David M. Crowley Research and Rehabilitation Lab in the School of Health Professions at University of Texas Southwestern Medical Center. The outcome measures for the study include: 1. GAITRite System for temporal and spatial parameters, 2. EMG of the anterior tibialis, gastrocnemius, and vastus lateralis muscles, 3. 6 Minute Walk Test (gait endurance) 4. Lower extremity strength, 5. MS Fatigue scale, 6. Observational Gait Analysis - Video tape of over ground walking. This study will be 13 weeks long. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10. They will be 60 minutes in duration. Outcome measures will be assessed at the following times: initial (T1), week 5 (T2), and week 13 (T3). Subjects will be closely monitored throughout the 13 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 study 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
- 21 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 >21 and <60 years old
- •Individuals who are able to maintain a walking velocity of 60 cm/sec for at least 2 minutes independently or with the use of a single tip assistive device.
- •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 >/= 35kg/m2
- •Individuals with range of motion deficit in the ankle limiting passive range of motion to neutral dorsiflexion
- •Individuals that will 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,
- •Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) of >22
- •Individuals for whom bilateral AFOs are indicated, but have different design
结局指标
主要结局
Change in Step Length From Initial Testing to End of Study
时间窗: Computerized gait analysis will be done at the time of enrollment and week 13.
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 Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing(Surface EMG will be done at the time of enrollment and week 13.)
研究者
Karen McCain
Assistant Professor, School of Health Professions
University of Texas Southwestern Medical Center