RecruitingEarly Phase 1NCT05760885

Multisensory Augmentation for Post-stroke Standing Balance

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

Sponsor

VA Office of Research and Development

Enrollment

36 participants

Start Date

Jan 14, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria5

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 Criteria6

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

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Interventions

BEHAVIORALBalance training with sensory augmentation

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.

BEHAVIORALBalance training

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.