Multisensory Augmentation for Post-stroke Standing Balance

NCT ID: NCT05760885

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2027-01-01

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.

Detailed Description

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sensory Augmentation

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

Group Type: EXPERIMENTAL

Balance training with sensory augmentation

Intervention Type: 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.

Control

Participants will receive balance training, without any sensory augmentation.

Group Type: ACTIVE_COMPARATOR

Balance training

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse C. Dean, PhD

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jesse C Dean, PhD

Role: CONTACT

Jesse.Dean@va.gov

(843) 792-9566

Aaron E Embry, DPT

Role: CONTACT

Aaron.Embry@va.gov

(843) 792-8198

Facility Contacts

Jesse C Dean, PhD

Role: primary

Jesse.Dean@va.gov

843-792-9566

Aaron E Embry, DPT

Role: backup

Aaron.Embry@va.gov

(843) 792-8198

Other Identifiers

I01RX004545

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A4545-R

Identifier Type: -

Identifier Source: org_study_id