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.
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.
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.
Parallel
Rise&Walk InHome by Healing Innovations
DeviceThe 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.
6-minute walk test
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.
ten-meter walk test
A performance-based measure of walking speed in which participants are timed while walking a 10-meter distance at their comfortable and/or fastest safe speed on a flat, level surface. Walking speed (m/s) is calculated by dividing distance in meters by time in seconds, often using the middle 6 meters to minimize acceleration and deceleration effects. Higher walking speeds indicate better functional mobility and gait performance, whereas slower speeds reflect greater gait impairment and reduced community ambulation capacity. Slower gait speeds have been associated with increased fall risk and reduced ability to safely navigate community environments.
Daily Step Count
Cumulative change in daily step count using a Step Tracking Device
Short Form (36) Health Survey
A 36-item self-report questionnaire assessing health-related quality of life across eight domains: Physical Functioning, Role Limitations due to Physical Health, Bodily Pain, General Health Perceptions, Vitality (Energy/Fatigue), Social Functioning, Role Limitations due to Emotional Problems, and Mental Health. Items are scored and transformed to yield domain scores ranging from 0 to 100, with higher scores indicating better health status and quality of life (less disability/fewer limitations). Summary scores (Physical Component Summary and Mental Component Summary) may also be calculated, with higher scores reflecting better overall physical or mental health.
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.
Modified Intrinsic Motivation Inventory (IMI) for Rise\&Walk InHome (RWH): An 18-item self-report questionnaire adapted from the Intrinsic Motivation Inventory to assess participants' motivation and user experience related to using the RWH device at home. Items are rated on a 7-point Likert scale (1 = Strongly Disagree to 7 = Strongly Agree). The measure includes six subscales: Interest/Enjoyment, Perceived Competence, Effort/Importance, Pressure/Tension, Value/Usefulness, and Usability \& Feasibility. Pressure/Tension items are reverse-scored so that higher scores reflect lower pressure or stress. Subscale scores are calculated by summing (or averaging) the items within each domain after reverse scoring, yielding a possible range of 1-7 for each item and higher scores indicating greater intrinsic motivation, perceived competence, effort, perceived value, usability, and lower pressure/tension related to RWH use.
Rating of Perceived Exertion (RPE) - Modified BORG
RPE will be measured for the treatment group only during their walking sessions. The technology software will use the Borg RPE scale. Responses for each domain will be rated using the revised category-ratio scale (0 \[nothing at all\] to 10 \[maximal\] ordinal response scale).
Walking compliance
e will model walking compliance as a proportion, with cumulative number of successful events from a series of successes and failures divided by the total number of assessments. The RWH system has a mobile application that shares usage data with an online HIPPA-compliant dashboard, which will be used to monitor walking compliance. Walking sessions on the RWH system will be performed 4 times per week over the course of the study. We will require a minimum of 30-minute sessions for successful participation in each walking routine.
System Usability Scale
Ease of use will be measured for the treatment group using the System Usability Scale (SUS). Each of the 10 questions on the SUS will be answered on a 5 pt ordinal scale, with responses ranging from "strongly agree" to "strongly disagree". The final possible scores ranging from 0 to 40 will be transformed to a 0 to 100 scale, based on the assumption that each question carries equal weight.
Cumulative incidence of adverse events
Adverse events (AEs) will be classified according to the International Classification of Diseases Version 10 (ICD-10) or another validated coding system for medical complications. Individual AE types will also be summarized.
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Healing Innovations
Lead sponsor
Kessler Foundation
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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