Exoskeleton for Balance

May 7, 2026 updated by: Jesse Dean, Medical University of South Carolina

Improving Mediolateral Walking Balance With an Assistive Exoskeleton

Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility.

Study Overview

Status

Status

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

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

Walking balance is an important component of functional mobility, with post-stroke balance deficits contributing to a fall rate more than double that of age-matched controls. Unfortunately, traditional therapy approaches have not succeeded in addressing balance deficits or reducing fall risk, motivating the use of technology to fill this gap. Although assistive exoskeletons are a promising approach to improve post-stroke mobility, they have generally not been designed to control walking balance and agility. This limitation is a particular concern in the development of devices for people with stroke, as applying forces to "assist" some aspect of walking (including balance) can have unexpected negative effects. The project goal is to investigate the potential of exoskeleton assistance to improve walking balance that will be accepted by people with stroke. To this end, investigators will use a previously developed hip exoskeleton to quantify the effects of assisting gait stabilization.

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 (Estimated)

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.
21

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.
  • Name: Jesse C. Dean, PhD
  • Phone Number: 8437929566
  • Email: deaje@musc.edu

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Jesse C Dean, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Evidence of a stroke at least 6 months prior to participation
  • Evidence of dysfunction of the paretic lower limb (Fugl-Meyer lower extremity motor score < 34)
  • At least 21 years of age
  • Self-reported experience of a fall in the previous year, and/or a fear of falling
  • Gait speed of at least 0.2 m/s
  • Ability to walk on a treadmill without a cane or walker
  • Ability to follow three step commands and communicate with experimenters to answer questions (e.g., regarding their balance confidence)
  • Provision of informed consent

Exclusion Criteria:

  • Resting blood pressure higher than 220/110 mm Hg
  • History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
  • Preexisting neurological orders or dementia
  • Legal blindness or severe visual impairment
  • Presence of neglect
  • History of DVT or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  • Orthopedic injuries or conditions (e.g., joint replacements) in the lower extremities with the potential to alter the gait pattern

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)
Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance.
Device: No Exoskeleton
The participant will not wear an exoskeleton
Device: Exoskeleton (zero impedance)
The participant will wear an exoskeleton with zero impedance
Device: Exoskeleton (low impedance)
The participant will wear an exoskeleton with low joint impedance
Device: Exoskeleton (medium impedance)
The participant will wear an exoskeleton with medium joint impedance
Device: Exoskeleton (high impedance)
The participant will wear an exoskeleton with high impedance

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
Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking
Time Frame: Visit 2, anticipated average 1 week
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 2, anticipated average 1 week
Partial correlation (rSW) between mediolateral pelvis displacement and step width during speed perturbations
Time Frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 4, anticipated average 1 year
Partial correlation (rSW) between mediolateral pelvis displacement and step width during vision perturbations
Time Frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 4, anticipated average 1 year
Partial correlation (rSW) between mediolateral pelvis displacement and step width during mediolateral pull perturbations
Time Frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 4, anticipated average 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking)
Time Frame: Visit 2, anticipated average 1 week
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 2, anticipated average 1 week
Average gluteus medius activity during stance phase (surface EMG) in unperturbed walking
Time Frame: Visit 2, anticipated average 1 week
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Visit 2, anticipated average 1 week
Average gluteus medius activity during swing phase (surface EMG) in unperturbed walking
Time Frame: Visit 2, anticipated average 1 week
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Visit 2, anticipated average 1 week
Rating of Perceived Stability (RPS) during unperturbed walking
Time Frame: Visit 2, anticipated average 1 week
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Visit 2, anticipated average 1 week
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during speed perturbations
Time Frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with speed perturbations
Time Frame: Visit 4, anticipated average 1 year
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with speed perturbations
Time Frame: Visit 4, anticipated average 1 year
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with speed perturbations
Time Frame: Visit 4, anticipated average 1 year
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Visit 4, anticipated average 1 year
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during vision perturbations
Time Frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with vision perturbations
Time Frame: Visit 4, anticipated average 1 year
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with vision perturbations
Time Frame: Visit 4, anticipated average 1 year
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with vision perturbations
Time Frame: Visit 4, anticipated average 1 year
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Visit 4, anticipated average 1 year
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during mediolateral pull perturbations
Time Frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with mediolateral pull perturbations
Time Frame: Visit 4, anticipated average 1 year
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with mediolateral pull perturbations
Time Frame: Visit 4, anticipated average 1 year
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with mediolateral pull perturbations
Time Frame: Visit 4, anticipated average 1 year
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Visit 4, anticipated average 1 year
Change in mediolateral foot placement (cm) during pull perturbations relative to unperturbed steps
Time Frame: Visit 4, anticipated average 1 year
The change in mediolateral foot placement locations between steps with and without pull perturbations will be calculated. This will be calculated separately for steps taken with each leg.
Visit 4, anticipated average 1 year

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.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Disability, Independent Living, and Rehabilitation Research

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.
May 6, 2026

Primary Completion (Estimated)

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.
June 1, 2027

Study Completion (Estimated)

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.
June 1, 2027

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).
December 8, 2025

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.
January 13, 2026

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.
January 21, 2026

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.
May 12, 2026

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.
May 7, 2026

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.
May 1, 2026

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.
  • Pro00135871
  • REGE22000170 (Other Grant/Funding Number: NIDILRR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD that underlie results in a publication will be shared.

IPD Sharing Time Frame

Relevant IPD and supporting information will be available within one year from when data is published, and will be available in perpetuity.

IPD Sharing Access Criteria

Relevant IPD and supporting information will be shared through an accessible server online. Our current plan is to use the NIH BRICS data depository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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