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NCT07250425

Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors

Sponsor: Healing Innovations

View on ClinicalTrials.gov

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.

Official title: Development of a Novel, Cost-Effective Gait Training Device Utilized at Home for the Neurological Patient Population

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08

Completion Date

2026-08

Last Updated

2026-03-09

Healthy Volunteers

Conditions

Stroke Neurological Diseases or Conditions Hemiparesis;Poststroke/CVA Gait Disorders, Neurologic Post Stroke Fatigue Motor Recovery Walking Difficulty Balance Impairment Falls Prevention Hemiparesis Mobility Limitation

Interventions

DEVICE

Rise&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.

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 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. Exclusion Criteria: * 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.

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States