Multisensory Augmentation for Post-stroke Standing Balance

NCT05760885 | Recruiting Early Phase 1 DMC

• 2 other identifiers: A4545-RI01RX004545
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale score change

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

  Before and after a 10-week period of balance training

Secondary Outcomes (4)

• Limits of Stability score (paretic direction)

  Before and after a 10-week period of balance training

• Limits of Stability score (non-paretic direction)

  Before and after a 10-week period of balance training

• Mediolateral center of pressure displacement

  Before and after a 10-week period of balance training

• Mediolateral center of pressure velocity

  Before and after a 10-week period of balance training

Study Arms (2)

Sensory Augmentation

EXPERIMENTAL

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

Behavioral: Balance training with sensory augmentation

Control

ACTIVE COMPARATOR

Participants will receive balance training, without any sensory augmentation.

Behavioral: Balance training

Interventions

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.

Sensory Augmentation

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.

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jesse C. Dean, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse C Dean, PhD

CONTACT

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

Aaron E Embry, DPT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will not be informed of which group participants are assigned to, and will not be present during an training sessions. As participants will be aware whether or not they will receive sensory augmentation (in the form of vibration), they can not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either a Control or an Experimental group. The Experimental group will receive sensory augmentation during balance training, while the Control group will not.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 8, 2023
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: We will share de-identified data upon study results publication, which we anticipate will happen within one year after study completion. Data will remain available in perpetuity.
• Access Criteria: All consumers of the scientific literature will have access to the shared de-identified data.

Locations

US (1)