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Multisensory Augmentation for Post-stroke Standing Balance (MAB)

Primary Purpose

Stroke

Status

Not yet recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Balance training with sensory augmentation

Balance training

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sensory Augmentation

Control

Arm Description

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

Participants will receive balance training, without any sensory augmentation.

Outcomes

Primary Outcome Measures

Berg Balance Scale score change

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT05760885

First Posted

February 23, 2023

Last Updated

March 6, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT05760885

Brief Title

Multisensory Augmentation for Post-stroke Standing Balance

Acronym

MAB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2024 (Anticipated)

Primary Completion Date

January 1, 2027 (Anticipated)

Study Completion Date

January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sensory Augmentation

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Participants will receive balance training, without any sensory augmentation.

Intervention Type

Behavioral

Intervention Name(s)

Balance training with sensory augmentation

Intervention Description

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

Intervention Name(s)

Balance training

Intervention Description

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 Information:

Title

Berg Balance Scale score change

Description

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

Time Frame

Before and after a 10-week period of balance training

Secondary Outcome Measure Information:

Title

Limits of Stability score (paretic direction)

Description

A standard assessment of how far participants are willing and able to shift their weight toward the paretic leg while standing

Time Frame

Before and after a 10-week period of balance training

Title

Limits of Stability score (non-paretic direction)

Description

A standard assessment of how far participants are willing and able to shift their weight toward the non-paretic leg while standing

Time Frame

Before and after a 10-week period of balance training

Title

Mediolateral center of pressure velocity

Description

A measure of sideways sway, which will be quantified as participants stand on a platform that translates sideways, challenging participant balance

Time Frame

Before and after a 10-week period of balance training

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jesse C Dean, PhD

Phone

(843) 792-9566

Jesse.Dean@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Aaron E Embry, DPT

Phone

(843) 792-8198

Aaron.Embry@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jesse C. Dean, PhD

Organizational Affiliation

Ralph H. Johnson VA Medical Center, Charleston, SC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ralph H. Johnson VA Medical Center, Charleston, SC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29401-5703

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jesse C Dean, PhD

Phone

843-792-9566

Jesse.Dean@va.gov

First Name & Middle Initial & Last Name & Degree

Aaron E Embry, DPT

Phone

(843) 792-8198

Aaron.Embry@va.gov

First Name & Middle Initial & Last Name & Degree

Jesse C. Dean, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Multisensory Augmentation for Post-stroke Standing Balance

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