Multisensory Augmentation for Post-stroke Standing Balance (MAB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Balance training with sensory augmentation; Behavioral: Balance training

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jesse C Dean, PhD; Phone Number: (843) 792-9566; Email: Jesse.Dean@va.gov
• Study Contact Backup: Name: Aaron E Embry, DPT; Phone Number: (843) 792-8198; Email: Aaron.Embry@va.gov

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5703
      • Recruiting
      • Ralph H. Johnson VA Medical Center, Charleston, SC
      • Contact: Aaron E Embry, DPT; Phone Number: (843) 792-8198; Email: Aaron.Embry@va.gov
      • Contact: Jesse C Dean, PhD; Phone Number: 843-792-9566; Email: Jesse.Dean@va.gov
      • Principal Investigator: Jesse C. Dean, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensory Augmentation; 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; 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.
Active Comparator: Control; Participants will receive balance training, without any sensory augmentation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limits of Stability score (paretic direction)	A standard assessment of how far participants are willing and able to shift their weight toward the paretic leg while standing	Before and after a 10-week period of balance training
Limits of Stability score (non-paretic direction)	A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing	Before and after a 10-week period of balance training
Mediolateral center of pressure velocity	A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance	Before and after a 10-week period of balance training
Mediolateral center of pressure displacement	A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance	Before and after a 10-week period of balance training

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jesse C. Dean, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: A4545-R; I01RX004545 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share de-identified data that contains no protected participant information. This data will be shared in the form of pre-prints and through online servers upon study results publication.
• IPD Sharing 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.
• IPD Sharing Access Criteria: All consumers of the scientific literature will have access to the shared de-identified data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No