An interventional study of Rise&Walk InHome by Healing Innovations in Stroke, Neurological Diseases or Conditions and Hemiparesis;Poststroke/CVA, sponsored by Healing Innovations. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Healing Innovations · Not applicable, Interventional, and Treatment
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.
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.
All participants (both groups) will receive a wearable step-tracking watch to measure daily step count during a 7-day baseline period and throughout the 12-week study. Outcome assessments will be completed at baseline and at approximately 4, 8, and 12 weeks. The primary efficacy endpoint is change in walking endurance as measured by the 6-Minute Walk Test (6MWT). Secondary endpoints include walking speed (10-Meter Walk Test), daily step count, and health-related quality of life. Tertiary feasibility and usability endpoints include device adherence and total minutes of RWH use, patient satisfaction and motivation, perceived usability, session-level exertion, and qualitative feedback captured during weekly check-ins. Adverse events (AEs) and serious adverse events (SAEs) will be tracked throughout the 12-week period, classified using standard medical coding, and summarized descriptively.
The target sample size of approximately 20 participants (10 per arm) is based on feasibility considerations and will support estimation of recruitment and adherence rates, variability in key outcome measures, and preliminary between-group effect sizes. Although the trial is not powered to detect small between-group differences, it is designed to (1) determine whether in-home use of the RWH is feasible, safe, and acceptable for stroke survivors and their assistants; (2) generate preliminary effect-size estimates for changes in 6MWT, 10MWT, step counts, and quality-of-life measures; and (3) identify practical considerations for larger, multi-site efficacy trials and for future reimbursement and implementation efforts.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 20 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Rise&Walk InHome by Healing Innovations
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.
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.
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.
Time frame: 0,4,8,12 weeks
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.
Time frame: 0,4,8,12 weeks
Daily Step Count
Cumulative change in daily step count using a Step Tracking Device
Time frame: Through study completion, on average 13 weeks.
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.
Time frame: 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.
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.
Time frame: 4,8,12 weeks
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).
Time frame: 4,8,12 weeks
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.
Time frame: 4,8,12 weeks
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.
Time frame: 4,8,12 for treatment group
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.
Time frame: Through Study Completion, approximately 12 months
Cumulative incidence of treatment-related and serious adverse events
An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Incidence of SAEs will be monitored until final follow-up or upon study exit.
Time frame: Through Study completion, approximately 12 months
Plan to share: Undecided
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