Recruiting
Early Phase 1

Sensory Augmentation

Sponsor:

VA Office of Research and Development

Code:

NCT05760885

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Balance training with sensory augmentation

Balance training

Study Details

Brief 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.

Conditions

Stroke

Study ID

NCT05760885

Start date

Jan 14, 2025

Status verified date

Dec, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age of at least 21 years;
2. Experience of a stroke at least 6 months prior to participation;
3. Berg Balance Scale score less than 52
4. 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
5. Provision of informed consent

Exclusion Criteria:

1. Resting blood pressure higher than 220/110 mm Hg
2. History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
3. Pre-existing neurological disorders or dementia
4. Severe visual impairment
5. History of DVT or pulmonary embolism within 6 months
6. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sensory Augmentation

Participants will receive sensory augmentation in the form of non-invasive vibration, while balance training is performed as described below.

active comparator: Control

Participants will receive balance training, without any sensory augmentation.

Interventions

Balance 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.

Balance 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.

Primary outcome measure

  • Berg Balance Scale score change [ Time Frame: Before and after a 10-week period of balance training ]

Central Contacts and Locations

Central contacts

Jesse C Dean, PhD

(843) 792-9566Jesse.Dean@va.gov

Aaron E Embry, DPT

(843) 792-8198Aaron.Embry@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Jesse C Dean, PhD

843-792-9566Jesse.Dean@va.gov

Aaron E Embry, DPT

(843) 792-8198Aaron.Embry@va.gov

Principal Investigator:

Jesse C. Dean, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 6, 2026

Last verified

Dec, 2025

Keywords

  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-06.