Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07356011

Exoskeleton for Balance

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Jesse C Dean, PhD

PRINCIPAL_INVESTIGATOR

Jesse C. Dean, PhD

CONTACT

[email protected]

8437929566

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No Exoskeleton

Device

The participant will not wear an exoskeleton

Exoskeleton (zero impedance)

Device

The participant will wear an exoskeleton with zero impedance

Exoskeleton (low impedance)

Device

The participant will wear an exoskeleton with low joint impedance

Exoskeleton (medium impedance)

Device

The participant will wear an exoskeleton with medium joint impedance

Exoskeleton (high impedance)

Device

The participant will wear an exoskeleton with high impedance

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jesse C. Dean, PhD

CONTACT

[email protected]

8437929566

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

Improving Mediolateral Walking Balance With an Assistive Exoskeleton

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
May 12, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.