NCT04648878

A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton

A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton in the Treatment of Individuals With Sub-acute and Chronic Stroke.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigator-initiated study is to establish if powered exoskeleton therapy as a part of a rehabilitation program can be used as a standard of care in stroke rehabilitation.

Detailed description

This prospective randomized control trial with three treatment arms will begin by: * Determining if the subject is a candidate for exoskeleton treatment. * Randomly assigning subjects to three groups (physical therapy only, exoskeleton only, or a hybrid of physical therapy and exoskeleton). * Body measurements to individualize the fit of the exoskeleton to each subject at each session. * Activities-based balance confidence (ABC) questionnaire will be administered before and after the study begins. * Timed up and go test (TUGT). * Ten-meter walk test (10MWT). * Six-minute walk test (6MWT) * Berg Balance Test (BBT). * Five times sit to stand (5XSTS). * Heart rate through a portable heartrate monitor.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	Hybrid combination of physical therapy and powered exoskeleton	18 alternating visits of conventional physical therapy and powered exoskeleton gait training with a wearable robotic powered exoskeleton , three times a week for approximately 6 weeks
OTHER	Powered Exoskeleton Only	18 visits of powered exoskelton only, three times a week for approximately 6 weeks
OTHER	Physical Therapy only	18 visits of physical therapy only, three times a week for approximately 6 weeks

Timeline

• Start date: 2021-02-14
• Primary completion: 2024-11-20
• Completion: 2024-12-18
• First posted: 2020-12-02
• Last updated: 2025-03-06

Locations

1 site across 1 country: United States