An Engineering-Based Balance Assessment and Training Platform

NCT03994770 | Completed

• 2 other identifiers: A3020-PI21RX003020
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proposal to develop a Balanced Reach Training Protocol (BRTP) to evaluate and train dynamic standing balance. The BRTP is based upon the Balanced Reach Test (BRT) that the investigators previously developed and validated. In the BRT subjects stand and point to a target disk moving unpredictably across a large projection screen in front of them without stepping. Body movements undertaken to track the disk are integral to many daily activities and represent an important class of "expected" balance disturbances that can precipitate falls. The BRTP employs engineering and psychophysical methods, and exploits advances in real time computing in a novel and innovative way to more effectively evaluate and train balance function. The BRTP presents a challenging reaching/tracking task that subjects perform at their limit of balance. The BRTP is an objective, quantitative test that can evaluate balance function without floor or ceiling effects, and train balance across the spectrum of aging, disease, and injury.

Conditions

Balance Deficits; Stroke

Keywords

Balance

Outcome Measures

Primary Outcomes (1)

• Root Mean Squared Deviation between Center of Mass and Center of Base of Support (RMSD)

  Measure of Balance Capability. Root Mean Squared Deviation (RMSD) records the root mean squared distance between the ground plane projection of whole-body Center of Mass and the center of the Base of Support during performance of the balanced reach task, in centimeters. It ranges from zero to the distance from the center of the Base of Support to the boundary of the Base of Support. Larger deviations indicate better performance than smaller deviations.

  Assess change between base line (just prior to training) and last 90 seconds of last training session at end of 1 week

Secondary Outcomes (2)

• Multi-Directional Reach Test

  Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week)

• Falls Efficacy Scale

  Assess change between base line (just prior to training) and within 24 hours of the end of training (1 week)

Study Arms (1)

STR

OTHER

Older people who have suffered a stroke

Diagnostic Test: Balanced Reach Assessment and Training Protocol

Interventions

Balanced Reach Assessment and Training Protocol DIAGNOSTIC_TEST

Three one-hour training sessions for one week in the Balanced Reach Training Protocol

STR

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old and in good health; 60 years and older
• For Ages 60 or older-stroke with persistent motor function deficit.
• For ages 18-40-experienced no falls in the past year. Fall is defined as a fall that occurs under conditions that an able body individual would not fall.
• Able to perform the balanced reach task without assistive devices for 90 seconds
• Able to perform a sit-to-stand with minimal assistance and walk 10 meters without human assistance
• Adequate language and neurocognitive function to give adequate informed consent \& to participate in testing and training
• Vision adequate to see a 1 inch diameter black disk against a white background at 3 feet
• Able to tolerate the use of Virtual Reality eyewear for \~10 minutes

You may not qualify if:

• Clinical history of:
• Any health condition that the study team deems would preclude safe completion of the BATP
• For ages 18-40-History of a stroke, orthopedic deficits, or sensorimotor deficits
• Body Mass Index (BMI) \>40
• Excessive daily alcohol consumption (\>3 oz. liquor; \>12 oz. wine; or \>36 oz. beer) or illicit drug abuse
• For ages 60 and older-Dementia based on Montreal Cognitive Assessment (MOCA) score of less than 23 for more than 9th grade education.
• Neurological disease other than stroke, such as Parkinson's disease. Vestibular disorders sufficient to preclude safe completion of the BATP or MMBI
• Poorly controlled hypertension (\>190/105) on at least two separate occasions
• Poorly controlled type 1 or 2 diabetes (HbA1c \>10)
• Recent hospitalization for severe disease or surgery (\<3 months)
• Congestive heart failure or valvular dysfunction symptomatic with ordinary activities (NYHA II)
• Self-reported Pregnancy
• Symptomatic orthostatic hypotension

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph E. Barton, MD PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Once the BATP is developed 20 stroke subjects will be recruited and the BATP's Assessment Module will be administered in order to verify its operation. After this is complete 10 stroke subjects will be randomly selected from this group and will undergo three one-hour training sessions over the course of one week to assess the operation of the BATP's Training Module.

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 21, 2019
• Study Start: November 15, 2021
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)