Development of a Novel, Cost-Effective Gait Training Device Utilized at Home for the Neurological Patient Population
Healing Innovations
Summary
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.
Description
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 clini…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 det…
Interventions
- DeviceRise&Walk InHome by Healing Innovations
The Rise\&Walk InHome (RWH) is a robotic gait training technology that allows for high repetition stepping practice safely in the home. A RWH device will be placed in the homes of participants in the treatment group. If needed, refresher training will be provided upon installation, and device settings will be configured based on the participant's most recent screening session. Participants in the treatment group will be instructed to use the RWH for 30 minutes per day, four times per week. Participants can achieve 30 minutes in ≥ 10 minute bouts throughout the day or if rest breaks are needed within the session. Individualized parameters will be established at Kessler, and participants will be educated on self-progression using the RPE monitor to track effort and progress.
Location
- Kessler FoundationWest Orange, New Jersey