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Clinical Trials/NCT03176511
NCT03176511
Completed
Not Applicable

Novel Dual-Task Balance Challenge to Prevent Falls in Older Adults

University of Arizona1 site in 1 country17 target enrollmentJuly 25, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Accidental Fall
Sponsor
University of Arizona
Enrollment
17
Locations
1
Primary Endpoint
Balance
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Poor balance is one of the major risk factors for falling in older adults. A Matter of Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite its name, MOB focuses on managing concerns about falling, and does not include a balance component. We are testing to see if adding a dual-task balance component (balance and mental thinking) to MOB can improve balance and walking better, than MOB only.

Detailed Description

Fall prevention interventions among community-dwelling older adults are essential. A Matter of Balance (MOB) is one of the most commonly used community-based fall prevention interventions nationally, and is considered the 'fall prevention standard of care'. MOB programs are targeted to reduce the fear of falling and promote physical activity among all older community-dwelling adults. While evidence indicates that the MOB program leads to small, sustained decreases in older adults' perceived fear of falling, there is no evidence of objectively measured balance and gait. Despite its name, MOB focuses on cognitive restructuring to manage concerns about falling, and does not include a balance component. Among community-dwelling older adults, both intact balance and concomitant attention ("dual-tasking") are essential to prevent falls, and dual-task balance components are now requisite per evidence-based fall prevention intervention guidelines.

Registry
clinicaltrials.gov
Start Date
July 25, 2017
End Date
March 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Community-dwelling older adults from all sex/gender and racial/ethnic groups, aged ≥ 60 years, at high fall risk (FRQ=Fall Risk Questionnaire score \> 4), who live in the greater Tucson, AZ area.

Exclusion Criteria

  • Older adults currently attending MOB or other fall prevention classes (e.g. Fall Proof), having a severe mobility disorder (e.g., unable to walk 15 feet with an assistive device), severe visual or hearing impairment, non-English speaking, lack of decision-making capacity, unable to provide informed consent, serious psychiatric disorder (e.g., schizophrenia), moderately-severe depression (PHQ-9=Patient Health Questionnaire ≥ 15), cognitive impairment (MMSE=Mini-Mental Status Exam ≤ 23), or serious medical condition (e.g., cancer treatments).

Outcomes

Primary Outcomes

Balance

Time Frame: Data will be collected at baseline and post-intervention at 4 weeks.

Balance will be assessed using LEGSys™ (Locomotion Evaluation and Gait System, BioSensics LLC) wearable technology. This system uses five sensors attached to right and left anterior shins, right and left anterior thighs, and to the posterior lower back. Balance measures will include changes in sway of ankle, hip, and center of mass (COM) in both mediolateral (ML) and anterior/posterior (AP) directions while standing, with feet parallel and in semi-tandem positions, during eyes-open (EO) and eyes-closed (EC) conditions (30 seconds/test).

Secondary Outcomes

  • Gait(Data will be collected at baseline and post-intervention at 4 weeks.)
  • Fear of Falling(Data will be collected at baseline and post-intervention at 4 weeks.)
  • 3-month incident Fall Rates(Data will be collected post-intervention at months 1, 2 and 3.)

Study Sites (1)

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