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NCT Number: NCT05760885

Multisensory Augmentation for Post-stroke Standing Balance

Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location status: Recruiting

Location contact

Aaron E Embry, DPT

CONTACT

[email protected]

(843) 792-8198

Jesse C Dean, PhD

CONTACT

[email protected]

843-792-9566

Jesse C. Dean, PhD

PRINCIPAL_INVESTIGATOR

About this study

The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age of at least 21 years;
  • Experience of a stroke at least 6 months prior to participation;
  • Berg Balance Scale score less than 52
  • Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole
  • 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
  • Pre-existing neurological disorders or dementia
  • Severe visual impairment
  • History of DVT or pulmonary embolism within 6 months
  • Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions

Treatment and study plan

Balance training with sensory augmentation

Behavioral

Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, sensory augmentation will be delivered with an intensity controlled in real-time by their center of pressure motion. The difficulty of the balance training task will progressively increase over successive training sessions.

Balance training

Behavioral

Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions.

Primary outcomes

  1. Berg Balance Scale score change

    Time frame: Before and after a 10-week period of balance training

    A standard clinical assessment to measure balance performance during various functional tasks

Secondary outcomes

  1. Limits of Stability score (paretic direction)

    Time frame: Before and after a 10-week period of balance training

    A standard assessment of how far participants are willing and able to shift their weight toward the paretic leg while standing

  2. Limits of Stability score (non-paretic direction)

    Time frame: Before and after a 10-week period of balance training

    A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing

  3. Mediolateral center of pressure displacement

    Time frame: Before and after a 10-week period of balance training

    A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance

  4. Mediolateral center of pressure velocity

    Time frame: Before and after a 10-week period of balance training

    A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance

Study contacts

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

Aaron E Embry, DPT

CONTACT

[email protected]

(843) 792-8198

Jesse C Dean, PhD

CONTACT

[email protected]

(843) 792-9566

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke

Acronym: MAB

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2023
Registry last updated
Jan 6, 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.

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