Exoskeleton for Balance

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: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: No Exoskeleton; Device: Exoskeleton (zero impedance); Device: Exoskeleton (low impedance); Device: Exoskeleton (medium impedance); Device: Exoskeleton (high impedance)

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: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Jesse C. Dean, PhD; Phone Number: 8437929566; Email: deaje@musc.edu
      • Principal Investigator: Jesse C Dean, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

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

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: walking; balance; exoskeleton
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID 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