NCT04380363

Safety and Usability of the Honda Walking Assist Device (HWA) in the Home Environment

Safety and Usability Assessment of the Honda Walking Assist Device (HWA) for Personal Use in Home and Community Environments

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Honda Walk Assist (HWA) device	Use of HWA for 2 months in the home setting
OTHER	SRALab fitness center membership	Membership to Shirley Ryan AbilityLab fitness center for 2 months

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-05-08
• Last updated: 2023-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study