Safety and Usability of the Honda Walking Assist Device (HWA) in the Home Environment
NCT ID: NCT04380363
Last Updated: 2023-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2021-06-30
2023-12-31
Brief Summary
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Detailed Description
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The HWA device is a lightweight, robotic exoskeleton designed to support people with gait deficits. The device is worn around the user's torso, waist and thighs, and assists with hip flexion and extension. The device weighs about 6lbs and has two motors that run on a single rechargeable battery. The device is equipped with angle and current sensors to monitor hip joint angle and torque output respectively. The adjustable assist torque (6Nm max.) is transmitted to the user's thighs via thigh frames. A trained healthcare professional can initially configure assist settings through software that runs on a mobile device. This trained professional can also make device adjustments to ensure a proper fit for the user and train the user for personal use of the HWA. After initial settings are established, users can don, doff and operate the device independently or with the help of an assistant.
Participant with stroke greater than 1 year ago will be recruited from outpatient clinics, day rehabilitation sites, and the hospital's research registry. Following a screening session to determine subject eligibility, subjects will be randomized to either the HWA or gym membership groups.
Baseline outcome measures will be collected and subjects will wear an ActiGraph activity monitor for 1-2 weeks. Subjects will then complete 1-3 sessions with a research physical therapist to acclimate and individualize the HWA device's settings or will be introduced to the Shirley Ryan AbilityLab gym and prescribed an individualized exercise program. During the 2 month intervention, subjects will either utilize the HWA device at home according to the prescribed settings or complete the prescribed exercise program at the Shirley Ryan AbilityLab fitness center. Weekly phone calls from the physical therapists will check in on both groups to determine whether participants are following their exercise programs and to answer any questions or concerns. At the conclusion of the 2 month intervention, participants will wear an ActiGraph monitor for 1-2 weeks and outcome measures will again be collected over 2 testing visits.
All testing and acclimation sessions will be performed under the supervision of a licensed physical therapist. Adverse events will be recorded.
The investigators anticipate this study will help determine the feasibility of using the Honda Walk Assist device in the home setting in individuals greater than a year post stroke. The investigators do not foresee any potential pitfalls.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Honda Walk Assist (HWA) Group
Participants utilize HWA device at home for 2 months according to prescribed settings.
Honda Walk Assist (HWA) device
Use of HWA for 2 months in the home setting
Control Group
Participants complete prescribed exercise program at the Shirley Ryan AbilityLab gym for 2 months.
SRALab fitness center membership
Membership to Shirley Ryan AbilityLab fitness center for 2 months
Interventions
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Honda Walk Assist (HWA) device
Use of HWA for 2 months in the home setting
SRALab fitness center membership
Membership to Shirley Ryan AbilityLab fitness center for 2 months
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Honda Research and Development Americas
INDUSTRY
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Research Scientist
Principal Investigators
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Arun Jayaraman, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00211619
Identifier Type: -
Identifier Source: org_study_id
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