LifeWalker Upright Walker Versus Conventional Rollator Walker and Predicate Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Test
研究概览
简要总结
The purpose of this project is to evaluate if the LifeWalker Upright walker is improves walking and reports of pain compared to a conventional rollator and predicate walker device.
详细描述
The LifeWalker Upright is a walker that has been designed to address fall risk, slouching, and user confidence and comfort. The LifeWalker has adjustable armrests and handles that enable users to stand tall and look ahead, providing support and stability that is designed differently than conventional walkers. The LifeWalker Upright's design allows the user to walk within the walker. This allows people to walk inside the walker as opposed to behind the walker.
The purpose of this project is to evaluate if the LifeWalker Upright walker is improves walking and reports of pain compared to a conventional rollator and predicate walker device
Aim 1: Perform in-laboratory training on the Life Walker and testing to compare functional gait outcomes with the Life Walker compared to a conventional rollator and predicate assistive mobility device. We expect that participants will be able to walk longer and will perform more efficiently on measures of gait function when using the Life Walker.
Aim 2: Perform in-laboratory testing to compare self-reported pain with the Life Walker compared to a conventional rollator and predicate assistive mobility device. We expect that participants will report less pain because they will have a more efficient and upright posture when using Life Walker.
Aim 3: Perform in-laboratory testing to compare measures of quality of life with the Life Walker compared to a conventional rollator and predicate mobility device. We expect that participants will report better outcomes on quality of life measures because they will experience better self-esteem due to better mobility when using Life Walker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who use a walker due to back pain or adults (over 18) who use a walker for ambulation.
- •Ages from 18 to 89 years old
- •Medically stable for therapy
排除标准
- •Patient weight exceeds 300 lbs
- •Patient height is below 5'0" or exceeds 6'3"
- •Inactive, physically unfit to fit into the device.
- •Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments.
- •Mini-Mental State Exam (MMSE) score below 17
- •Pregnant women
- •Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)
研究组 & 干预措施
Started with Forearm Support Walker (LW Upright)
Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
干预措施: Standard Rollator (Device)
Started with Forearm Support Walker (LW Upright)
Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
干预措施: LifeWalker Upright (Device)
Started with Forearm Support Walker (LW Upright)
Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
干预措施: Predicate Device (Device)
Standard Rollator Walker (Control)
Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
干预措施: LifeWalker Upright (Device)
Standard Rollator Walker (Control)
Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
干预措施: Predicate Device (Device)
Standard Rollator Walker (Control)
Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
干预措施: Standard Rollator (Device)
Predicate Device (PD)
Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
干预措施: LifeWalker Upright (Device)
Predicate Device (PD)
Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
干预措施: Predicate Device (Device)
Predicate Device (PD)
Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
干预措施: Standard Rollator (Device)
结局指标
主要结局
6 Minute Walk Test
时间窗: One testing session
The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The 6minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. The number of stops and stumbles will be recorded during the test. This test will be administered while wearing a mask to measure oxygen consumption in addition to blood pressure, heart rate and oxygen saturation.
次要结局
- 10 Meter Walk Test(One testing session)
- Borg Rate of Perceived Exertion(One testing session)
- Forearm and Hand Grip(One testing session)
- Baseline Modified Falls Efficacy Scale (mFES) Score:(Baseline score taken at first session)
- Visual Analog Pain Scale (VAS)(Baseline score taken at first session)
- User Functional Rating Scale(One testing session)
研究者
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab