Safety and Usability of the Honda Walking Assist Device (HWA) in the Home Environment

NCT04380363 | Unknown DMC FDA Device

• 1 other identifier: STU00211619
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to verify the safety and validate the usability of the Honda Walk Assist (HWA) device in the home setting versus an exercise program without the device in a gym setting for individuals diagnosed with stroke. The investigators hypothesize that the HWA exoskeleton is a safe and effective device for use by individuals diagnosed with stroke in the home environment.

Conditions

Stroke

Keywords

Stroke; Gait; Honda Walk Assist

Outcome Measures

Primary Outcomes (3)

• HWA Device Log

  The HWA device is equipped with sensors that can detect hip joint angle movement. This joint angle data can be downloaded to an external computer. In the HWA group, HWA log data could provide an objective measure of participant activity when the HWA device is activated. HWA will be solely responsible for managing log data and will provide information of device use and misuse among therapists and study participants. This will also help determine device malfunctions.

  2 months of at-home training

• Honda Training Experience Survey

  Each participant in the HWA group will be given a tablet to obtain subjective feedback about the HWA device and home training experience. These tablets will contain pre-loaded questions for subjects to answer on a daily basis to obtain information about device usability in the home setting.

  2 months of at-home training

• 10 Meter Walk Test (10MWT)

  The 10MWT assesses walking speed in meters per second over a short duration of 10 meters (33 ft). In the 10MWT, subjects are directed to walk at their self-selected and maximum safe speed with the effects of acceleration and deceleration minimized by adding 1 meter at the beginning and at the end of the course to isolate the subject's steady state speed. Any assistive device and orthotic are kept consistent and documented. Gait speed at both the "self-selected walking speed" or "fastest walking speed" are recorded. The 10MWT has been validated for the stroke population and is accepted as a responsive, functional measurement of the patient's ability to ambulate over short distances such as those typical to a household setting.

  Baseline; Post-testing (after 2 month intervention)

Secondary Outcomes (10)

• 6 Minute Walk Test (6MWT)

  Baseline; Post-testing (after 2 month intervention)

• Gait Analysis

  Baseline; Post-testing (after 2 month intervention)

• Functional Gait Assessment (FGA)

  Baseline; Post-testing (after 2 month intervention)

• Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)

  Baseline; Post-testing (after 2 month intervention)

• Manual Muscle Testing (MMT)

  Baseline; Post-testing (after 2 month intervention)

Study Arms (2)

Honda Walk Assist (HWA) Group

EXPERIMENTAL

Participants utilize HWA device at home for 2 months according to prescribed settings.

Device: Honda Walk Assist (HWA) device

Control Group

ACTIVE COMPARATOR

Participants complete prescribed exercise program at the Shirley Ryan AbilityLab gym for 2 months.

Other: SRALab fitness center membership

Interventions

Honda Walk Assist (HWA) device DEVICE

Use of HWA for 2 months in the home setting

Honda Walk Assist (HWA) Group

SRALab fitness center membership OTHER

Membership to Shirley Ryan AbilityLab fitness center for 2 months

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 1 year post stroke
• initial gate speed of \> 0.2 m/s and \< 0.8 m/s
• adequate cognitive function (MMSE score \>17)
• subject is willing to be randomized to the control group or the treatment group
• ability to sit unsupported for 30 seconds
• ability to walk at least 10m without physical assist
• ability to follow a 3-step command
• physician approval for patient participation
• living in the community post-stroke with the ability to travel to the intervention site to participate in the outpatient program and able to perform the home exercise program in a residential facility

You may not qualify if:

• participants who cannot move their limbs through the physical limits of the device (range of motion)
• less than 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)
• less than 6 months post CABG or cardiac valve procedure
• serious medical conditions including myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living, severe hypertension, severe weight bearing pain, life expectancy less than one year
• preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
• history of major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, renal dialysis or end stage liver disease, legal blindness or severe visual impairment, a history of significant psychiatric illness
• pacemakers, metal implants in the head region
• subject is pregnant, nursing or planning a pregnancy
• expressive aphasia
• participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results
• inability to perform 5 times per week for the home rehabilitation program
• individuals who need to use a walker with the device

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Honda Research and Development Americas: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arun Jayaraman, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

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: Research Scientist

Model Details: Subjects randomized into device or control group.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: June 30, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)