The Impact of Hearing Loss Severity on Balance Intervention Outcomes
Primary Purpose
Hearing Loss, Fall, Postural Balance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A Matter of Balance: Managing Concerns about Falls
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A Matter of Balance Program
Arm Description
Outcomes
Primary Outcome Measures
Change in postural sway from baseline to after completion of AMOB
Postural sway will be assessed using a Balance Tracking Systems pressure plate.
Secondary Outcome Measures
Change in balance confidence from baseline to after completion of AMOB
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.
Change in falls risk from baseline to after completion of AMOB
Assessed via Falls Risk Questionnaire. Point values are allocated to each questionnaire item (range: 0-14) with higher scores suggesting a greater falls risk.
Full Information
NCT ID
NCT05681078
First Posted
December 21, 2022
Last Updated
June 22, 2023
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT05681078
Brief Title
The Impact of Hearing Loss Severity on Balance Intervention Outcomes
Official Title
The Impact of Hearing Loss Severity on Balance Intervention Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Fall, Postural Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A Matter of Balance Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
A Matter of Balance: Managing Concerns about Falls
Intervention Description
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 Outcome Measure Information:
Title
Change in postural sway from baseline to after completion of AMOB
Description
Postural sway will be assessed using a Balance Tracking Systems pressure plate.
Time Frame
baseline and within 1 month post training
Secondary Outcome Measure Information:
Title
Change in balance confidence from baseline to after completion of AMOB
Description
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.
Time Frame
baseline and within 1 month post training
Title
Change in falls risk from baseline to after completion of AMOB
Description
Assessed via Falls Risk Questionnaire. Point values are allocated to each questionnaire item (range: 0-14) with higher scores suggesting a greater falls risk.
Time Frame
baseline and within 1 month post training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlin Price, AuD, PhD
Phone
501-686-8125
Email
CEPrice@uams.edu
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Price, AuD, PhD
12. IPD Sharing Statement
Learn more about this trial
The Impact of Hearing Loss Severity on Balance Intervention Outcomes
We'll reach out to this number within 24 hrs