Safety and Usability Assessment of the Honda Walking Assist Device (HWA) for Personal Use in Home and Community Environments
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- 10 Meter Walk Test (10MWT)
研究概览
简要总结
The purpose of this study is to verify the safety and validate the usability of the Honda Walk Assist (HWA) device in the home setting versus an exercise program without the device in a gym setting for individuals diagnosed with stroke. The investigators hypothesize that the HWA exoskeleton is a safe and effective device for use by individuals diagnosed with stroke in the home environment.
详细描述
The purpose of this randomized control trial is to determine the safety and usability of the Honda Walk Assist (HWA) device in the home environment versus a gym membership. Secondarily, the study will investigate effects of the HWA exoskeleton in the home environment versus a gym membership on gait function and overall home training activity. Participants who are greater than 1 year post stroke and between the ages of 18-80 will be included.
The HWA device is a lightweight, robotic exoskeleton designed to support people with gait deficits. The device is worn around the user's torso, waist and thighs, and assists with hip flexion and extension. The device weighs about 6lbs and has two motors that run on a single rechargeable battery. The device is equipped with angle and current sensors to monitor hip joint angle and torque output respectively. The adjustable assist torque (6Nm max.) is transmitted to the user's thighs via thigh frames. A trained healthcare professional can initially configure assist settings through software that runs on a mobile device. This trained professional can also make device adjustments to ensure a proper fit for the user and train the user for personal use of the HWA. After initial settings are established, users can don, doff and operate the device independently or with the help of an assistant.
Participant with stroke greater than 1 year ago will be recruited from outpatient clinics, day rehabilitation sites, and the hospital's research registry. Following a screening session to determine subject eligibility, subjects will be randomized to either the HWA or gym membership groups.
Baseline outcome measures will be collected and subjects will wear an ActiGraph activity monitor for 1-2 weeks. Subjects will then complete 1-3 sessions with a research physical therapist to acclimate and individualize the HWA device's settings or will be introduced to the Shirley Ryan AbilityLab gym and prescribed an individualized exercise program. During the 2 month intervention, subjects will either utilize the HWA device at home according to the prescribed settings or complete the prescribed exercise program at the Shirley Ryan AbilityLab fitness center. Weekly phone calls from the physical therapists will check in on both groups to determine whether participants are following their exercise programs and to answer any questions or concerns. At the conclusion of the 2 month intervention, participants will wear an ActiGraph monitor for 1-2 weeks and outcome measures will again be collected over 2 testing visits.
All testing and acclimation sessions will be performed under the supervision of a licensed physical therapist. Adverse events will be recorded.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 1 year post stroke
- •initial gate speed of > 0.2 m/s and < 0.8 m/s
- •adequate cognitive function (MMSE score >17)
- •subject is willing to be randomized to the control group or the treatment group
- •ability to sit unsupported for 30 seconds
- •ability to walk at least 10m without physical assist
- •ability to follow a 3-step command
- •physician approval for patient participation
- •living in the community post-stroke with the ability to travel to the intervention site to participate in the outpatient program and able to perform the home exercise program in a residential facility
排除标准
- •participants who cannot move their limbs through the physical limits of the device (range of motion)
- •less than 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)
- •less than 6 months post CABG or cardiac valve procedure
- •serious medical conditions including myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living, severe hypertension, severe weight bearing pain, life expectancy less than one year
- •preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
- •history of major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, renal dialysis or end stage liver disease, legal blindness or severe visual impairment, a history of significant psychiatric illness
- •pacemakers, metal implants in the head region
- •subject is pregnant, nursing or planning a pregnancy
- •expressive aphasia
- •participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results
- •inability to perform 5 times per week for the home rehabilitation program
- •individuals who need to use a walker with the device
结局指标
主要结局
10 Meter Walk Test (10MWT)
时间窗: Baseline; Post-testing (after 2 month intervention)
The 10MWT assesses walking speed in meters per second over a short duration of 10 meters (33 ft). In the 10MWT, subjects are directed to walk at their self-selected and maximum safe speed with the effects of acceleration and deceleration minimized by adding 1 meter at the beginning and at the end of the course to isolate the subject's steady state speed. Any assistive device and orthotic are kept consistent and documented. Gait speed at both the "self-selected walking speed" or "fastest walking speed" are recorded. The 10MWT has been validated for the stroke population and is accepted as a responsive, functional measurement of the patient's ability to ambulate over short distances such as those typical to a household setting.
HWA Device Log
时间窗: 2 months of at-home training
The HWA device is equipped with sensors that can detect hip joint angle movement. This joint angle data can be downloaded to an external computer. In the HWA group, HWA log data could provide an objective measure of participant activity when the HWA device is activated. HWA will be solely responsible for managing log data and will provide information of device use and misuse among therapists and study participants. This will also help determine device malfunctions.
Honda Training Experience Survey
时间窗: 2 months of at-home training
Each participant in the HWA group will be given a tablet to obtain subjective feedback about the HWA device and home training experience. These tablets will contain pre-loaded questions for subjects to answer on a daily basis to obtain information about device usability in the home setting.
次要结局
- Functional Gait Assessment (FGA)(Baseline; Post-testing (after 2 month intervention))
- Manual Muscle Testing (MMT)(Baseline; Post-testing (after 2 month intervention))
- Activites-Specific and Balance Confidence Scale (ABC)(Baseline; Post-testing (after 2 month intervention))
- Stroke Specific Quality of Life (SSQoL)(Baseline; post-testing (after 2 month intervention))
- Physical Therapist Interview(Post-testing (after 2 month intervention))
- Gait Analysis(Baseline; Post-testing (after 2 month intervention))
- 6 Minute Walk Test (6MWT)(Baseline; Post-testing (after 2 month intervention))
- Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)(Baseline; Post-testing (after 2 month intervention))
- Passive Range of Motion (PROM)(Baseline; Post-testing (after 2 month intervention))
- Modified Ashworth Test (MAS)(Baseline; Post-testing (after 2 month intervention))
研究者
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab