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NCT Number: NCT04648878

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid combination of physical therapy and powered exoskeleton

Other

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 Only

Other

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

Physical Therapy only

Other

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

Primary outcomes

  1. Timed up and go test

    Time frame: Pre and post tests up to six weeks apart

    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.

  2. Ten meter walk test

    Time frame: Pre and post tests up to six weeks apart

    Subjects will be timed as they walk a known distance of 10 meters to determine his self-selected walking velocity (distance/time). They will be timed. Takes five minutes to administer.

  3. 6 minute walk test

    Time frame: Pre and post tests up to six weeks apart

    This test measures distance walked in six minutes to assess a patient's physical endurance. They walk at a self-selected speed and will be timed. This test takes approximately 10 minutes to administer

  4. Berg Balance Test

    Time frame: Pre and post tests up to six weeks apart

    The Berg balance test is a reliable measure for predicting risk for fall. This 14-item test measures static and dynamic balance measures and takes 15-20 minutes to administer

  5. The Activities-specific Balance Confidence (ABC) Scale

    Time frame: Pre and post tests up to six weeks apart

    This has been shown to be an effective tool for assessing the psychological impact of balance impairment and falls and measuring an individual's balance confidence. Using a Likert scale, this self-administered test evaluates a person's confidence in balance over various activities. This 16-question test takes 5 to 10 minutes to complete.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2020
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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