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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Aug 31, 2026

Status verified

Mar 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Treatment Group: Rise&Walk InHome Walking Group
  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.
• No Intervention: Control Group: Usual Care
  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.

Primary Outcome Measure

6-minute walk test [ Time Frame: 0,4,8,12 weeks ]

Central Contacts

• Karen Nolan, PhD
  973-324-3544
  [email protected]
• Julie Hartman, DPT
  615-965-5020
  [email protected]

Locations (1)

Find similar trials in West Orange, NJ

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