Effects of Two Different Types of Ankle Foot Orthoses on Gait Outcomes in Patients With Subacute Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Gait Endurance
研究概览
简要总结
PURPOSE: The purpose of this study will be to identify whether patients in the subacute stage of stroke, who demonstrate foot drop, will have better gait outcomes when using a Double Adjustable AFO, or a Posterior Leaf Spring AFO. A secondary purpose will be to determine whether one week of practice significantly changes gait outcomes with either of the AFO conditions.
INCLUSION CRITERIA: Twenty participants over the age of 18, of any gender and ethnicity, diagnosed with first time unilateral stroke, 4 - 20 weeks post-stroke onset, resulting in hemiparesis with foot drop will be recruited for this study.
EXCLUSION CRITERIA:
- Not able to receive a double adjustable AFO through their insurance
- Unable to follow two steps commands
- Unable to ambulate 20 feet with or without assistive device with a minimum level of assistance of contact guard assistance.
- Cerebellar Stroke
- Inability to ambulate prior to stroke
- receiving chemotherapy at the time of study
OUTCOME MEASURES:
- Six Minute walk test
- Gait Symmetry and Gait velocity measured with GAITRite for self paced velocity walk and fast paced velocity walk.
DATA COLLECTION:
Data will be collected three times over two weeks period.
First Visit:
Demographics, Fugl-Meyer Lower Extremity Assessment of sensorimotor function, Mini Mental State Examination 6MWT and GAITRite measurements using Both types of AFO in a random order. Afterwards participant will be given one type of AFO (randomly selected) to practice walking for a week.
Second Visit: 6MWT and GAITRite measurements using the type of AFO they were practicing with. Then the other type of AFO will be given to practice walking for a week.
Third Visit: 6MWT and GAITRite measurements using the second type of AFO that they were practicing with the week prior. Patient will be asked which type of AFO they prefer to use.
详细描述
Introduction: Stroke is a leading cause of death and disability in the world today. About 795,000 people are diagnosed with stroke yearly in the United States. The annual cost of stroke from medical services and disability in our nation is $ 38.6 billion dollars. Gait rehabilitation is an important aspect of neurorehabilitation with focus on attaining the most functional and symmetrical gait to prevent falls from faulty gait mechanics, and to prevent sedentary life styles and associated comorbidities. Ankle foot orthoses (AFOs) are commonly prescribed in patients with stroke to address ankle and knee instabilities and to restore a normal and safe walking pattern.The effectiveness of AFOs on various gait parameters has been reported in patients with stroke, but mostly during the chronic stages of recovery. Systematic analyses have shown that use of various types of ankle foot orthoses improve walking impairments and balance, reduce energy costs, and improve knee and ankle kinematics in people in the chronic stage of stroke recovery, greater than 6 months since the onset of stroke. It is reported that the majority of the gait improvements occur within the first 6 months following the onset of stroke. However, a limited number of studies have investigated the effects of AFOs within six months of stroke onset.
Three reported studies have investigated the effects of using an AFO compared to not using an AFO within 6 months following onset of stroke. Rao et al found that the use of an AFO significantly improved gait velocity, cadence and step length on the affected and unaffected side. Hyun et al. found that using an AFO significantly improved VO2 peak and 6 minute walk test scores . Carse et al showed significant improvement in walking velocity, average step length and cadence with use of AFO. There is only one reported study which looked at the effects of using two different types of AFOs during the subacute stage of stroke, less than 6 months following onset. Results of this study showed that gait speed and knee and ankle control were significantly higher in the Chignon AFO group compared to the polypropylene AFO group. Additionally, participants in the Chignon AFO group had significantly lower spasticity than those in the polypropylene AFO group.
In a recent case series report, investigators observed that using a custom Double Adjustable AFO during the early stages of recovery after stroke resulted in more typical muscle activation patterns, gait endurance and velocity, and near normal symmetry during gait without an assistive device or an AFO in three participants. The use of this type of AFO for gait rehabilitation following stroke in the subacute stages has not been thoroughly studied.
Statement of the Problem Patients with stroke resulting in hemiparesis and foot drop are affected by gait impairments such as poor symmetry, decreased velocity, and decreased endurance. AFOs have been shown to be an effective intervention for improving gait parameters in individuals who are in the chronic stage of stroke recovery. Although, the majority of gait improvements occur within six months of stroke, the effect of early bracing with different types of AFOs on gait outcomes has not been investigated thoroughly.
Purpose of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosed with first time unilateral stroke
- •4 - 20 weeks post-stroke onset
- •resulting in hemiparesis with foot drop
排除标准
- •Inability to receive a double adjustable AFO through their insurance
- •unable to follow two steps commands
- •unable to ambulate 20 feet with or without assistive device with a minimum level of assistance of contact guard assistance
- •diagnosis of cerebellar stroke
- •non ambulatory prior to stroke onset
结局指标
主要结局
Gait Endurance
时间窗: 1 week of practice with DA AFO and with PLS AFO randomly
6MWT to assess gait endurance
次要结局
- Gait Symmetry(at baseline,1 week with DA AFO, 1 week with PLS AFO)
- Gait Velocity SSV and FPV(at baseline,1 week with DA AFO, 1 week with PLS AFO)
