Rise&Walk InHome for Stroke

Overseen By Ben Taylor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Healing Innovations

Disqualifiers: Osseous instability, Joint contractures, Cardiovascular conditions, Psychiatric status, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robotic device called Rise&Walk InHome, designed to help individuals who have experienced a stroke or spinal cord injury improve their ability to walk at home. Researchers aim to determine if the device is easy to use, safe, and more effective in improving walking ability compared to usual care. The trial includes a group using the device and a control group receiving typical care. Participants should have experienced a first-time stroke affecting their legs, be able to stand for 30 minutes, and be between 1 month and 5 years post-stroke. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance rehabilitation options for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Rise&Walk InHome system is safe for individuals with stroke or spinal cord injury?

Research shows that the Rise&Walk InHome (RWH) is a robotic device designed to help people practice walking at home. Studies have found that it enables stroke patients to walk safely and repeatedly, which is crucial because many stroke survivors struggle with walking even years after their stroke.

Although detailed safety data from these studies is not available, testing the RWH in a clinical trial suggests some confidence in its safety. At this stage, trials usually indicate the device is considered safe enough for use. For those considering joining this trial, the RWH aims to provide an affordable and accessible way to improve walking ability after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Rise&Walk InHome is unique because it brings stroke rehabilitation directly into patients' homes, allowing for a more personalized and convenient approach. Unlike traditional rehabilitation that often requires travel to clinics, this device lets patients exercise at home, which can be more flexible and less stressful. Researchers are excited about this treatment because it empowers patients to self-progress using a Rate of Perceived Exertion (RPE) monitor and tracks their activity with a FitBit, potentially leading to better adherence and outcomes. By integrating technology and convenience, this approach could make stroke recovery more accessible and effective for many individuals.

What evidence suggests that the Rise&Walk InHome system is effective for stroke rehabilitation?

Research has shown that the Rise&Walk InHome system, which participants in this trial may receive, can improve movement in stroke patients. In earlier studies, people using this system demonstrated better movement, as seen in tests measuring balance and mobility. This robotic device helps users walk more easily at home, aiding in their recovery. The system enables users to practice walking movements repeatedly, which is crucial for improving walking skills. Early results suggest it could offer an affordable way to continue rehabilitation at home instead of in a clinic. ^{1 2 3 5 6}

Who Is on the Research Team?

Julie Hartman, DPT

Principal Investigator

Healing Innovations

Are You a Good Fit for This Trial?

This trial is for stroke survivors or individuals with spinal cord injury who have difficulty walking, limited mobility, or balance issues. Participants should be able to use a novel robotic gait training system at home and must not be part of another similar study.

Inclusion Criteria

Ability to give written consent and comply with the study procedures

Independent Use: Pass training course

Dependent Use: Caregiver plus individual pass training course

Exclusion Criteria

Height is above or below the range: 5ft - 6ft 4in

Significant differences in leg length

Any medical condition preventing active rehabilitation and/or the use of the device (e.g., seizure risk, respiratory disease, pregnancy, orthopedic conditions, infections or inflammatory disorders, osteomyelitis)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Usability Optimization

Optimization of the RWH device's hardware and software through human factor testing and structured feedback

4 weeks

Multiple visits (in-person and virtual)

Pilot Randomized Controlled Trial

Participants use the RWH system at home or continue usual care; outcomes measured monthly

12 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Rise&Walk InHome

Trial Overview The Rise&Walk InHome by Healing Innovations is being tested. It's a new robotic device designed for home use that helps people with stroke or SCI improve their walking ability. The study compares the effectiveness of this device against usual care in a pilot randomized controlled trial.

How Is the Trial Designed?

Group I: Treatment Group: Rise&Walk InHome Walking Group Active Control 1 Intervention

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. The treatment group will also wear a FitBit to track daily step count activity.

Group II: Control Group: Usual Care Active Control 1 Intervention

The control group will receive usual care, which may vary based on individual needs, physical therapist recommendations, geographic location, and clinic access. Study outcomes will be assessed at predetermined time points by the research team at Kessler Institute. The control group will wear a FitBit to track daily step count activity.

Who Is Running the Clinical Trial?

Healing Innovations

Lead Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Kessler Foundation

Collaborator

Trials

190

Recruited

11,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07250425?aggFilters=status%3A%2Cphase%3A

Development and Efficacy of a Novel, Cost-Effective Gait ... This study evaluates the usability and clinical impact of the Rise&Walk InHome™ (RWH), a novel robotic gait training system designed for ...

2. medicaldevicenavigator.com medicaldevicenavigator.com/cost_effective_gait_training_clinical_trial/

Cost-Effective Gait Training Solution Unveiled for Stroke ... Rise&Walk InHome represents a promising step in stroke rehabilitation, offering a home-based solution to improve mobility and recovery. This clinical trial ...

3. ctv.veeva.com ctv.veeva.com/study/development-and-efficacy-of-a-novel-cost-effective-gait-training-device-utilized-at-home-for-stroke

Development and Efficacy of a Novel, Cost-Effective Gait ... This study evaluates the usability and clinical impact of the Rise&Walk InHome™ (RWH), a novel robotic gait training system designed for ...

4. researchgate.net researchgate.net/publication/394576403_Functional_Mobility_Outcomes_Following_Robotic-Assisted_Gait_Training_with_RiseWalkR_in_Inpatient_Stroke_Rehabilitation_A_Retrospective_Pilot_Study

Functional Mobility Outcomes Following Robotic-Assisted ... Rise&Walk participants received 2–8 sessions per stay (mean: 4.2). Outcomes included seven Section GG mobility items, the Berg Balance Scale ( ...

5. sciety-discovery.elifesciences.org sciety-discovery.elifesciences.org/articles/by?article_doi=10.21203/rs.3.rs-7266083/v1

Functional Mobility Outcomes Following Robotic-Assisted Gait ... Rise&Walk participants received 2–8 sessions per stay (mean: 4.2). Outcomes included seven Section GG mobility items, the Berg Balance Scale ( ...

6. reporter.nih.gov reporter.nih.gov/search/Sz95MmEj-Uu3HV2keOw4Nw/project-details/10919097

Development of a novel, cost-effective gait training device ... It has been reported that over 25% of stroke patients identify as “non-community walkers” and almost 66% have ongoing issues with mobility in the five years ...