Status:
UNKNOWN
Safety and Usability of the Honda Walking Assist Device (HWA) in the Home Environment
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
Honda Research and Development Americas
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
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 fo...
Detailed Description
The purpose of this randomized control trial is to determine the safety and usability of the Honda Walk Assist (HWA) device in the home environment versus a gym membership. Secondarily, the study will...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04380363
Start Date
June 30 2021
End Date
December 1 2023
Last Update
August 8 2023
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611