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

NCT07250425 | Not Yet Recruiting FDA Device

• 2 other identifiers: 1R44HD1134511R44HD113451-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

in-home rehabilitation; Robotic-Assisted Gait Training; gait training device; stroke recovery; functional mobility; rehabilitation technology; remote monitoring; rehabilitation robotics; Fitbit Step Tracking; Self-Directed Gait Training; high-intensity gait training; Neurorehabilitation Research; Lower Limb Rehabilitation; Motor Function Recovery; Physical Therapy; Walking Endurance; task specific walking practice; neurological recovery; stroke rehabilitation; home exercise program; Rise&Walk InHome; daily step count; 6-minute walk test; 10-meter walk test

Outcome Measures

Primary Outcomes (1)

• 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.

  0,4,8,12 weeks

Secondary Outcomes (4)

• ten-meter walk test

  0,4,8,12 weeks

• Daily Step Count

  Through study completion, on average 13 weeks.

• Short Form (36) Health Survey

  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.

  4,8,12 weeks

Other Outcomes (5)

• Rating of Perceived Exertion (RPE) - Modified BORG

  4,8,12 weeks

• Walking compliance

  4,8,12 weeks

• System Usability Scale

  4,8,12 for treatment group

Study Arms (2)

Treatment Group: Rise&Walk InHome Walking Group

ACTIVE COMPARATOR

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

Control Group: Usual Care

NO INTERVENTION

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.

Interventions

Rise&Walk InHome by Healing Innovations DEVICE

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.

Treatment Group: Rise&Walk InHome Walking Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• First-ever ischemic or hemorrhagic stroke confirmed by medical record.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Healing Innovations: lead
• Kessler Foundation: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (5)

• Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.

  PMID: 31834165 BACKGROUND

• Mehrholz J, Thomas S, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD006185. doi: 10.1002/14651858.CD006185.pub5.

  PMID: 33091160 BACKGROUND

• Luo L, Zhu S, Shi L, Wang P, Li M, Yuan S. High Intensity Exercise for Walking Competency in Individuals with Stroke: A Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2019 Dec;28(12):104414. doi: 10.1016/j.jstrokecerebrovasdis.2019.104414. Epub 2019 Sep 27.

  PMID: 31570262 BACKGROUND

• de Menezes KKP, Ada L, Teixeira-Salmela LF, Scianni AA, Avelino PR, Faria CDCM, Nascimento LR. Home-Based Interventions may Increase Recruitment, Adherence, and Measurement of outcomes in Clinical Trials of Stroke Rehabilitation. J Stroke Cerebrovasc Dis. 2021 Oct;30(10):106022. doi: 10.1016/j.jstrokecerebrovasdis.2021.106022. Epub 2021 Aug 4.

  PMID: 34364011 BACKGROUND

• Hu MM, Wang S, Wu CQ, Li KP, Geng ZH, Xu GH, Dong L. Efficacy of robot-assisted gait training on lower extremity function in subacute stroke patients: a systematic review and meta-analysis. J Neuroeng Rehabil. 2024 Sep 19;21(1):165. doi: 10.1186/s12984-024-01463-1.

  PMID: 39300491 BACKGROUND

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Mobility Limitation; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Hartman, DPT

  Healing Innovations

  PRINCIPAL INVESTIGATOR

• Karen Nolan, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

• Ben Taylor

  Healing Innovations

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Nolan, PhD

CONTACT

973-324-3544; knolan@kesslerfoundation.org

Julie Hartman, DPT

CONTACT

615-965-5020; julie@healinginnovations.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Physical Therapy, Vice President of Clinical Development & Strategy

Model Details: Participants will be randomized 1:1 to either home-based robotic gait training with the Rise\&Walk InHome device plus usual care or usual care alone for 12 weeks.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: November 26, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)