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

March 3, 2025 updated by: Loma Linda University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A - Hybrid combination
Group A (n=12) will receive 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: 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
Experimental: Group B - Powered Exoskeleton only
Group B (n=12) will receive 18 visits of powered exoskeleton only, 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
Experimental: Group C - Physical Therapy only
Group C (n=12) will receive 18 visits of physical therapy, three times a week for approximately 6 weeks. Upon completion of the data collection portion of the study, group C will receive 9 sessions, three times a week for approximately three weeks of powered exoskeleton therapy. Data will not be collected or reported during this phase, but but may be retained for future approved use.
Other: Physical Therapy only
18 visits of physical therapy only, three times a week for approximately 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre and post tests up to six weeks apart
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.
Pre and post tests up to six weeks apart
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
Pre and post tests up to six weeks apart
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
Pre and post tests up to six weeks apart
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.
Pre and post tests up to six weeks apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loma Linda University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Davidson, MSE MPH, Loma Linda University O&P

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5190407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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