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

Last updated: March 3, 2025
Sponsor: Loma Linda University
Overall Status: Completed

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Hybrid combination of physical therapy and powered exoskeleton

Powered Exoskeleton Only

Physical Therapy only

Clinical Study ID

NCT04648878
5190407
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 normalrange-of-motion for the knees, hips, and ankles

Exclusion

Exclusion Criteria:

  • Exclusion criteria will include those who have already experienced poweredexoskeleton therapy.

Study Design

Total Participants: 6
Treatment Group(s): 3
Primary Treatment: Hybrid combination of physical therapy and powered exoskeleton
Phase:
Study Start date:
February 14, 2021
Estimated Completion Date:
December 18, 2024

Study 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.

Connect with a study center

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Site Not Available

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