Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Functional Independence Measure (FIM™)
研究概览
简要总结
The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
详细描述
Abstract
Objective
The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
Background:
Method: The investigators will study 50 patients with stroke consecutively admitted to a designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either the experimental (exoskeleton) or the control (over-ground) groups by computer-generated randomization. This is an open-label pragmatic trial, where neither the patients nor the clinicians could be masked to the intervention. Institution review board (IRB) approval will be obtained for the protocol. The demographic data to be collected includes: age, gender, race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke severity (on the National Institute of Health Stroke Severity [NIHSS] scale. Admission and discharge total Functional Independence Measure (FIM), spasticity and depression scores, ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM, depression and spasticity scores. The secondary outcome measure was discharge disposition. Continuous variables were analyzed using Students t-test, ordinal variables were analyzed using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
- •Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- •Depressed patients will be included in the study
- •Patients able to stand alone
- •Patients able to provide a written informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21).
排除标准
- •Aphasic patients unable to communicate
- •Confused patients
- •Patients medically unstable
- •Patients unable to stand alone
- •Refusal to provide written informed consent
结局指标
主要结局
The Functional Independence Measure (FIM™)
时间窗: Baseline (Day 1) and at 4-weeks to measure change
It measure the degree of disability as well as the progress patients make throughout their medical rehabilitation programs. FIM Scale score varies from minimum of 18 to maximum of 126. Higher score better the outcome.
The two minute walk test (2-MWT)
时间窗: Baseline (Day 1) and at 4-weeks to measure change
It assess the walking distance over two minutes while moving at a comfortable speed. using any ambulation aids (such as cane, walkers, and rollators) used in everyday life. Normal walking speed is 360 ft.
次要结局
- Discharge disposition(4-weeks)
- Modified Ashworth Scale (MAS)(Baseline (Day 1) and at 4-weeks to measure change)
- The Beck Depression Inventory (BDI)(Baseline (Day 1) and at 4-weeks to measure change)