Clinical trial NCT04380363: Safety and Usability of the Honda Walking Assist Device (HWA) in the Home Environment
Official title: Safety and Usability Assessment of the Honda Walking Assist Device (HWA) for Personal Use in Home and Community Environments
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Gait
Honda Walk Assist
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Honda Research and Development Americas
First posted: 2020-05-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects randomized into device or control group.
Primary purpose: TREATMENT

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.

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 investigate effects of the HWA exoskeleton in the home environment versus a gym membership on gait function and overall home training activity. Participants who are greater than 1 year post stroke and between the ages of 18-80 will be included.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: HWA Device Log
timeFrame: 2 months of at-home training
measure: Honda Training Experience Survey
timeFrame: 2 months of at-home training
measure: 10 Meter Walk Test (10MWT)
timeFrame: Baseline; Post-testing (after 2 month intervention)
Secondary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Gait Analysis
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Manual Muscle Testing (MMT)
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Modified Ashworth Test (MAS)
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Passive Range of Motion (PROM)
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Activites-Specific and Balance Confidence Scale (ABC)
timeFrame: Baseline; Post-testing (after 2 month intervention)
measure: Stroke Specific Quality of Life (SSQoL)
timeFrame: Baseline; post-testing (after 2 month intervention)
measure: Physical Therapist Interview
timeFrame: Post-testing (after 2 month intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PhD
role: PRINCIPAL_INVESTIGATOR
References: