Exoskeleton for Balance

NCT07356011 | Recruiting

• 2 other identifiers: Pro00135871REGE22000170
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

walking; balance; exoskeleton

Outcome Measures

Primary Outcomes (4)

• Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking

  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

  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

  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

  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 Outcomes (17)

• Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking)

  Visit 2, anticipated average 1 week

• Average gluteus medius activity during stance phase (surface EMG) in unperturbed walking

  Visit 2, anticipated average 1 week

• Average gluteus medius activity during swing phase (surface EMG) in unperturbed walking

  Visit 2, anticipated average 1 week

• Rating of Perceived Stability (RPS) during unperturbed walking

  Visit 2, anticipated average 1 week

• Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during speed perturbations

  Visit 4, anticipated average 1 year

Study Arms (1)

xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)

EXPERIMENTAL

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; Device: Exoskeleton (zero impedance); Device: Exoskeleton (low impedance); Device: Exoskeleton (medium impedance); Device: Exoskeleton (high impedance)

Interventions

Exoskeleton (zero impedance) DEVICE

The participant will wear an exoskeleton with zero impedance

xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)

Exoskeleton (low impedance) DEVICE

The participant will wear an exoskeleton with low joint impedance

xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)

Exoskeleton (medium impedance) DEVICE

The participant will wear an exoskeleton with medium joint impedance

xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)

Exoskeleton (high impedance) DEVICE

The participant will wear an exoskeleton with high impedance

xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)

No Exoskeleton DEVICE

The participant will not wear an exoskeleton

xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jesse C. Dean, PhD

CONTACT

8437929566; deaje@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Model Details: All participants will experience the same series of experimental sessions. Within individual sessions, the order in which different exoskeleton conditions are tested will be randomized.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 21, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Relevant IPD and supporting information will be available within one year from when data is published, and will be available in perpetuity.
• 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.

Locations

US (1)