- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05681078
The Impact of Hearing Loss Severity on Balance Intervention Outcomes
October 31, 2024 updated by: University of Arkansas
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A Matter of Balance Program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline and within 1 month post training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline and within 1 month post training
|
|
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.
|
baseline and within 1 month post training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2023
Primary Completion (Actual)
September 15, 2023
Study Completion (Actual)
September 15, 2023
Study Registration Dates
First Submitted
December 21, 2022
First Submitted That Met QC Criteria
January 8, 2023
First Posted (Actual)
January 12, 2023
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
October 31, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 275305
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.