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OpenTrials
Completed

NCT Number: NCT05681078

The Impact of Hearing Loss Severity on Balance Intervention Outcomes

The goal of this study is to learn about how hearing loss impacts balance intervention outcomes and risk of falling in older adults. The main questions it aims to answer are:

* How does the evidence-based A Matter of Balance (AMOB) program affect older adults' falls risk and balance-related measures? * Is the severity of someone's hearing loss related to their balance intervention (AMOB) outcomes?

Participants will:

* Complete a hearing and balance test * Answer some questions about their background and health history, their thoughts about potential falls and how this impacts them, and their current physical activity level * Participate in the A Matter of Balance Program, an evidence-based program that includes group discussion, activities, and exercises to reduce fall risk

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Key information

Conditions

Hearing Loss Ear Diseases Fall Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Postural Balance Sensation Disorders Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age of 60 years old or greater
  • absence of any major physical or health condition that would prevent participation in the intervention sessions
  • English speaking

Exclusion criteria

  • severe balance disorder diagnosis
  • uncorrected severe vision impairment

Treatment and study plan

A Matter of Balance: Managing Concerns about Falls

Behavioral

A Matter of Balance is an evidence-based program targeting physical activity and fall prevention for adults 60 years of age and older. This program incorporates active learning discussions and activities along with exercise training to reduce the fear of falling, improve fall efficacy and management, and increase physical activity levels in older adults.

Primary outcomes

  1. Change in postural sway from baseline to after completion of AMOB

    Time frame: baseline and within 1 month post training

    Postural sway will be assessed using a Balance Tracking Systems pressure plate.

Secondary outcomes

  1. Change in balance confidence from baseline to after completion of AMOB

    Time frame: baseline and within 1 month post training

    Assessed via the Activity-Specific Balance Confidence Scale. Each item is rated as a percentage reflecting an individual's level of confidence in being able to perform the activity without losing their balance (0% - no confidence, 100% - completely confident). The ratings are then averaged across the 16 items for the total score. A higher score suggests higher self confidence related to balance.

  2. Change in falls risk from baseline to after completion of AMOB

    Time frame: baseline and within 1 month post training

    Assessed via Falls Risk Questionnaire. Point values are allocated to each questionnaire item (range: 0-14) with higher scores suggesting a greater falls risk.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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