StrokeNCT04380363
Safety and Usability of the Honda Walking Assist Device (HWA) in the Home Environment
A study testing Honda Walk Assist (HWA) device and SRALab fitness center membership in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Honda Walk Assist (HWA) device and SRALab fitness center membership
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Usability Assessment of the Honda Walking Assist Device (HWA) for Personal Use in Home and Community Environments
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Honda Walk Assist (HWA) device, SRALab fitness center membership
- Keywords
- Stroke, Gait, Honda Walk Assist
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honda Walk Assist (HWA) deviceDevice
Use of HWA for 2 months in the home setting
SRALab fitness center membershipOther
Membership to Shirley Ryan AbilityLab fitness center for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Honda Walk Assist (HWA) Group | Experimental | Participants utilize HWA device at home for 2 months according to prescribed settings. Receives: Device: Honda Walk Assist (HWA) device |
| Control Group | Active comparator | Participants complete prescribed exercise program at the Shirley Ryan AbilityLab gym for 2 months. Receives: Other: SRALab fitness center membership |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline; Post-testing (after 2 month intervention)
Secondary outcomes (10)
6 Minute Walk Test (6MWT)
The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The distance is measured with a measuring wheel. The instructions are "Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed, but time will keep running." The change in the distance walked in the 6-minute walk can be used to evaluate the efficacy of an exercise-training program or to trace the natural history of change in exercise capacity over time. The 6MWT is measured in meters. For the HWA intervention group, this will be tested both with and without use of the HWA device.
Measured: Baseline; Post-testing (after 2 month intervention)
Gait Analysis
A quantitative means of assessing gait function in adults post-stroke based on spatiotemporal parameters of gait. The GAITRite® system is an electronic walkway with integrated sensors and is considered a reliable and valid means of assessing gait changes post-stroke. For the HWA intervention group, this will be tested both with and without use of the HWA device.
Measured: Baseline; Post-testing (after 2 month intervention)
Functional Gait Assessment (FGA)
The FGA is a 10-item test for assessing postural stability during various walking tasks. It includes 7 of the 8 items from the original Dynamic Gait Index, and 3 new items, including "gait with narrow base of support", "ambulating backwards", and "gait with eyes closed". The FGA demonstrates excellent concurrent validity with the Berg Balance Scale for individuals with stroke. The maximum score is 30 points; minimal detectable change for chronic stroke is 4.2 points.
Measured: Baseline; Post-testing (after 2 month intervention)
Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
The purpose of the FMA is to evaluate and measure recovery in post-stroke hemiplegic patients. There are five domains assessed on a 3-point ordinal scale from 0-2. "0" is equal to "cannot perform", "1" is equal to "performs partially", and "2" is equal to "performs fully". The domain for lower extremity motor function will be used. It has been found to be reliable and valid in assessing individuals with stroke with a minimal clinically important difference of 10 points for the lower extremity motor scores.
Measured: Baseline; Post-testing (after 2 month intervention)
Manual Muscle Testing (MMT)
The purpose of this test is to evaluate the strength of the legs by having the subject hold the legs in a position while the researcher applies manual resistance.
Measured: Baseline; Post-testing (after 2 month intervention)
Modified Ashworth Test (MAS)
The purpose of this test is to evaluate the amount of spasticity in the legs.
Measured: Baseline; Post-testing (after 2 month intervention)
Passive Range of Motion (PROM)
The purpose of this test is to evaluate a subject's passive range of motion in the joints of the hips, knees and ankles.
Measured: Baseline; Post-testing (after 2 month intervention)
Activites-Specific and Balance Confidence Scale (ABC)
The ABC is a 16-item self-report questionnaire that measures confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence. It has good to excellent reliability and adequate construct validity, correlating with the BBS and 10MWT.
Measured: Baseline; Post-testing (after 2 month intervention)
Stroke Specific Quality of Life (SSQoL)
The SSQoL is a self-report questionnaire that is accepted as a reliable and valid way to assess health-related quality of life specific to stroke survivors. Subjects respond to 49 questions in 12 domains: mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Each individual domain consists of 3 to 10 items that are averaged to generate an overall score, each item is rated on a 5- point Likert scale, with a minimum value of 1 (meaning the worst outcome) and a maximum value of 5 (meaning the best outcome). Domains scores (non-weighted average of item scores) and a summary score (non-weighted average of all 12 domain scores) are computed. Summary scores range from 49-245, with higher scores indicating better functioning.
Measured: Baseline; post-testing (after 2 month intervention)
Physical Therapist Interview
During the final post-test session at SRAlab, therapists will ask participants various questions about their experience throughout the study. This could be through a verbal discussion or through a written questionnaire. The purpose of this interview is to collect subjective feedback from therapists and study participants regarding overall impressions of device use.
Measured: Post-testing (after 2 month intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start30 Jun 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized into device or control group.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Honda Research and Development Americas
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380363
- Sponsor's protocol ID
- STU00211619
- Status last verified
- Aug 2023
- First submitted
- 5 May 2020
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability Assessment of the Honda Walking Assist Device (HWA) for Personal Use in Home and Community Environments
- ClinicalTrials.gov ID
- NCT04380363
- Acronym / sponsor ID
- STU00211619
- Conditions
- Stroke
- Keywords
- Stroke, Gait, Honda Walk Assist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Honda Research and Development Americas
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects randomized into device or control group.
| Arm | Type | Receives |
|---|---|---|
| Honda Walk Assist (HWA) Group | Experimental | Device: Honda Walk Assist (HWA) deviceParticipants utilize HWA device at home for 2 months according to prescribed settings. |
| Control Group | Active comparator | Other: SRALab fitness center membershipParticipants complete prescribed exercise program at the Shirley Ryan AbilityLab gym for 2 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honda Walk Assist (HWA) deviceUse of HWA for 2 months in the home setting | Device | Honda Walk Assist (HWA) Group |
| SRALab fitness center membershipMembership to Shirley Ryan AbilityLab fitness center for 2 months | Other | Control Group |
Primary outcome
HWA Device Log
Time frame: 2 months of at-home training
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.
Honda Training Experience Survey
Time frame: 2 months of at-home training
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.
10 Meter Walk Test (10MWT)
Time frame: Baseline; Post-testing (after 2 month intervention)
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.
10 secondary outcomes
6 Minute Walk Test (6MWT)
Time frame: Baseline; Post-testing (after 2 month intervention)
Gait Analysis
Time frame: Baseline; Post-testing (after 2 month intervention)
Functional Gait Assessment (FGA)
Time frame: Baseline; Post-testing (after 2 month intervention)
Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
Time frame: Baseline; Post-testing (after 2 month intervention)
Manual Muscle Testing (MMT)
Time frame: Baseline; Post-testing (after 2 month intervention)
Modified Ashworth Test (MAS)
Time frame: Baseline; Post-testing (after 2 month intervention)
Passive Range of Motion (PROM)
Time frame: Baseline; Post-testing (after 2 month intervention)
Activites-Specific and Balance Confidence Scale (ABC)
Time frame: Baseline; Post-testing (after 2 month intervention)
Stroke Specific Quality of Life (SSQoL)
Time frame: Baseline; post-testing (after 2 month intervention)
Physical Therapist Interview
Time frame: Post-testing (after 2 month intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Jayaraman, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honda Walk Assist (HWA) device and SRALab fitness center membership in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HWA Device Log (time frame: 2 months of at-home training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.