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

Loma Linda University6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Hybrid combination of physical therapy and powered exoskeletonOTHER

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

Powered Exoskeleton OnlyOTHER

18 visits of powered exoskelton only, three times a week for approximately 6 weeks

Physical Therapy onlyOTHER

18 visits of physical therapy only, three times a week for approximately 6 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and Females 18 years of age or older post-stroke * 3 Ashworth score are involved in a standing program less than 220 lbs 5'0" through 6'4" have the ability to follow one-step commands near normal range-of-motion for the knees, hips, and ankles Exclusion Criteria: * Exclusion criteria will include those who have already experienced powered exoskeleton therapy.

Locations (1)

Loma Linda University

Loma Linda, California, United States

Outcomes

Primary Outcomes

Timed up and go test

Subject sits in a standard armchair and stands, and at a self-selected walking speed, walks 3 meters, turns, and walks back to the chair, and sits down. They will be timed. Takes three minutes to administer.