The Walking Assist Device features a function to influence the user to achieve efficient walking based on the inverted pendulum model, which is a theory of bipedal walking, and is designed as a device to be used in the training of walking.
The Walking Assist Device helps users walk more efficiently based on the inverted pendulum model, which is a theory of bipedal walking, and is designed as a device to be used in walking therapy/training under the guidance of a doctor and/or therapist.
The device, which is meant to assist patients with spinal cord injuries or other mobility-limiting conditions walk, was cleared for sale in the European market towards the end of 2015. It resembles a pair of standalone robotic legs which users can attach with a strap above their waists and helps manipulate joint and lower limb movements.
Layout table for study information Study Type : Interventional (Clinical Trial) EstimatedEnrollment : 28 participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Subjects randomized into device or control group. Masking: None (Open Label) Primary Purpose: Treatment Official Title: Safety and Usability Assessment of the Honda Walking Assist Device (HWA) for Personal Use in Home and Community Environments Actual Study Start Date : June 30, 2021 Estimated Primary Completion Date : May 2023 Estimated Study Completion Date : May 2023 Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Experimental: Honda Walk Assist (HWA) GroupParticipants utilize HWA device at home for 2 months according to prescribed settings. Device: Honda Walk Assist (HWA) deviceUse of HWA for 2 months in the home setting Active Comparator: Control GroupParticipants complete prescribed exercise program at the Shirley Ryan AbilityLab gym for 2 months. Other: SRALab fitness center membershipMembership to Shirley Ryan AbilityLab fitness center for 2 months Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : 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. Secondary Outcome Measures : 6 Minute Walk Test (6MWT) [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]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. Gait Analysis [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]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. Functional Gait Assessment (FGA) [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]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. Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]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. Manual Muscle Testing (MMT) [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]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. Modified Ashworth Test (MAS) [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]The purpose of this test is to evaluate the amount of spasticity in the legs. Passive Range of Motion (PROM) [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]The purpose of this test is to evaluate a subject's passive range of motion in the joints of the hips, knees and ankles. Activites-Specific and Balance Confidence Scale (ABC) [ Time Frame: Baseline; Post-testing (after 2 month intervention) ]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. Stroke Specific Quality of Life (SSQoL) [ Time Frame: Baseline; post-testing (after 2 month intervention) ]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. Physical Therapist Interview [ Time Frame: Post-testing (after 2 month intervention) ]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. Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 781b155fdc