NCT07250425Not yet recruiting
Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors
Development of a Novel, Cost-Effective Gait Training Device Utilized at Home for the Neurological Patient Population
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 May 2025
- Start date
- Aug 2026
- Primary completion date
- Aug 2026
- Lead sponsor
- Healing Innovations
- Diseases
- Stroke
- NCT number
- NCT07250425
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Aug 2026 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Any other condition that, in the opinion of the investigators, would make participation unsafe or interfere with study adherence or outcome interpretation.
Other
- Current participation in another interventional trial targeting gait or lower-extremity function.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kessler Foundation Coordinator of this site? Confirm its status | West Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.