Development of a Novel, Cost-Effective Gait Training Device Utilized at Home for the Neurological Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 6-minute walk test
研究概览
简要总结
This pilot, parallel-group randomized controlled trial will evaluate the feasibility, safety, usability, and preliminary efficacy of the Rise&Walk InHome (RWH), a novel robotic gait training device designed for home use after stroke. Twenty adults with lower-extremity motor impairment following a first-ever stroke (3 months to 5 years post-event) will be randomized 1:1 to either (1) RWH-assisted home walking plus usual care or (2) usual care alone for 12 weeks. Participants in the intervention group will receive an in-home RWH device, complete a structured device training program, and be instructed to perform 30-minute RWH walking sessions four times per week (48 sessions total). All participants will undergo standardized outcome assessments at baseline, weeks 4, 8, and 12, including the 6-Minute Walk Test (primary outcome), 10-Meter Walk Test, daily step count via wearable activity tracker, and health-related quality of life (SF-36). Additional feasibility and usability outcomes include device use and adherence, patient satisfaction and motivation, ease of use, perceived exertion, and adverse events. Findings will inform the feasibility of in-home deployment of the RWH device and provide preliminary effect-size estimates to guide the design of a larger efficacy trial.
详细描述
This study is Aim 3 of a larger NIH-funded project to develop and evaluate the Rise&Walk InHome (RWH), a stationary robotic gait training device designed to deliver high-repetition, high-intensity stepping exercise in the home for individuals with walking limitations after stroke. Aims 1 and 2 focus on hardware and software usability optimization and device safety testing; Aim 3, described here, is a pilot clinical trial to assess feasibility, safety, usability, and preliminary clinical efficacy of the RWH compared with usual care.
Stroke survivors frequently face barriers to accessing clinic-based high-dose gait training, including transportation, cost, and limited availability of advanced rehabilitation technologies. High-intensity, task-specific gait training can improve walking speed, endurance, and function after stroke, yet these gains often fail to translate into increased real-world walking activity. Bringing robotic stepping into the home may improve access, enable higher cumulative training doses, and support more consistent engagement. The RWH is a transfer-accessible, body-weight-support gait trainer that transitions users from sit to stand and guides the legs through a stepping pattern while allowing adjustable body-weight offload, speed, and assistance. An integrated touchscreen interface and remote dashboard support parameter progression, safety monitoring, and adherence tracking.
This parallel-group, single-blind randomized controlled trial will enroll approximately 20 adults with a first-ever stroke and lower-extremity motor impairment who are 3 months to 5 years post-stroke and able to stand for at least 30 minutes with minimal assistance. After informed consent, eligibility screening, home evaluation, and technology competency training at the clinical site, participants will be randomized (1:1) to either the RWH intervention plus usual care or usual care alone. Randomization will occur only after participants (and, if needed, an assistant) successfully complete a structured RWH training and competency checklist and the home environment is deemed suitable for safe device installation.
Intervention group (RWH + usual care): Participants assigned to the intervention will receive an RWH device installed in their home by an engineer and physical therapist. Device settings (e.g., speed, body-weight support, assistance levels) will be individualized based on baseline assessments and in-clinic training. Participants will be instructed to perform 30-minute walking sessions on the RWH four times per week for 12 weeks (with up to 60 minutes per day allowed to accommodate warm-up, cool-down, and rest breaks). They will use the built-in Borg CR10 Rating of Perceived Exertion (RPE) tool to target high-intensity gait training during work intervals, with lower-intensity periods for recovery. Device-recorded data (session duration, step count, assistance, body-weight support, and average RPE) will be transmitted to a secure, HIPAA-compliant dashboard. Weekly phone or virtual check-ins with the study team will review progress, adjust training parameters as needed, and monitor safety and technical issues.
Control group (usual care): Participants in the control arm will continue with standard outpatient or home-based rehabilitation services as recommended by their clinical providers, including any prescribed home exercise programs. The study team will not prescribe or alter usual care. Control participants will wear a study-provided activity tracker and complete simple weekly logs to document rehabilitation visits, duration, and types of activities, as well as adherence to prescribed home exercises. Periodic check-in calls will be used to clarify logs and monitor safety.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •First-ever ischemic or hemorrhagic stroke confirmed by medical record.
- •3 months to 5 years post-stroke at time of enrollment.
- •Presence of lower-extremity motor impairment limiting walking function.
- •Able to stand for at least 30 minutes with no more than minimal assistance (with or without a device).
- •Medically stable and cleared by a physician to participate in moderate-intensity ambulation exercise.
- •Living in a home environment that can safely accommodate device installation (e.g., adequate space, appropriate flooring, and power access) as determined by the study team.
- •Able to understand study procedures and provide informed consent (or have a legally authorized representative), with sufficient cognitive and communication skills to follow simple instructions.
- •If assistance is required for transfers or device set-up, availability of a caregiver or assistant willing to participate in training and device use.
排除标准
- •Unstable cardiovascular, respiratory, or other medical conditions that contraindicate moderate- to high-intensity walking exercise (e.g., unstable angina, decompensated heart failure, uncontrolled arrhythmias).
- •Severe musculoskeletal or orthopedic conditions limiting safe participation in supported stepping (e.g., unstable fractures, severe contractures preventing positioning in the device).
- •Severe spasticity or movement disorders that would preclude safe use of the device, based on investigator judgment.
- •Severe cognitive impairment, aphasia, or behavioral disturbance that would prevent informed consent or safe participation.
- •Progressive neurological conditions (e.g., progressive neurodegenerative disease) expected to significantly worsen over the 12-week study period.
- •Current participation in another interventional trial targeting gait or lower-extremity function.
- •Any other condition that, in the opinion of the investigators, would make participation unsafe or interfere with study adherence or outcome interpretation.
研究组 & 干预措施
Treatment Group: Rise&Walk InHome Walking Group
Participants will receive an in-home Rise&Walk InHome robotic gait training device in addition to their usual rehabilitation care. They will be instructed to perform 30-minute sessions of device-based walking four times per week for 12 weeks, with individualized device parameters and weekly remote check-in calls with the study team to monitor safety, adherence, and progression.
干预措施: Rise&Walk InHome by Healing Innovations (Device)
Control Group: Usual Care
Participants will continue to receive usual outpatient or home-based rehabilitation services as recommended by their treating clinicians, including any prescribed home exercise programs. No Rise&Walk InHome device will be provided. Participants will wear an activity tracker and complete weekly logs documenting rehabilitation visits and home exercise adherence. They will also receive brief weekly remote check-in calls with the study team for clarification of step counting logs.
结局指标
主要结局
6-minute walk test
时间窗: 0,4,8,12 weeks
A standardized submaximal exercise test that measures functional exercise capacity by recording the total distance a participant can walk on a flat, straight course in six minutes. The primary outcome is walking distance, typically recorded in meters. Higher distances indicate better functional mobility and aerobic capacity, whereas shorter distances reflect greater impairment or reduced endurance.
次要结局
- ten-meter walk test(0,4,8,12 weeks)
- Daily Step Count(Through study completion, on average 13 weeks.)
- Short Form (36) Health Survey(0,4,8,12 weeks)
- Modified version of the Intrinsic Motivation Inventory (IMI) designed to include 26 relevant items from the full set of 45 items in the original questionnaire.(4,8,12 weeks)
研究者
Julie Hartman
Doctor of Physical Therapy, Vice President of Clinical Development & Strategy
Healing Innovations