Status:
COMPLETED
A Balanced Assessment and Training Protocol (BATP) to Address Balance Disorders in Older and Neurologically Disabled Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Older Men and Women With High Fall Risk
Eligibility:
All Genders
60+ years
Brief Summary
Falls are by far the leading cause of accidental injury and death in older adults. The Veteran population is more severely affected by falls since it is significantly older than the overall population...
Detailed Description
Overview: This study comprises three Specific Aims (SAs): SA-1) Development of the Balanced Assessment and Training Protocol (BATP). SA-2) Assessment of the BATP's training efficacy. SA-3) Assessment ...
Eligibility Criteria
Inclusion
- 18-40 years old and in good health; 60 years and older
- 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
- For ages 60 and older-High Fall Risk or At Risk for Falling as defined by one or more of the following: Self reported fall twice or more in the past year, Self reported fear of falling, Four Square Step Test time greater than 12 seconds as determined by the study team.
- 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
Exclusion
- Any health condition that the study team deems would preclude safe completion of the BATP or MMBI
- 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 such as stroke, limb paralysis, Parkinson's disease, or 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 month)
- Congestive heart failure or valvular dysfunction symptomatic with ordinary activities (NYHA II)
- Self-reported Pregnancy.
- Symptomatic orthostatic hypotension
- Participant has/had or currently is in a personal (romantic) relationship with any member on the study team.
Key Trial Info
Start Date :
November 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 13 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04359888
Start Date
November 9 2021
End Date
August 13 2025
Last Update
January 9 2026
Active Locations (1)
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1
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201