NCT05681078

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

February 8, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 4, 2024

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

December 21, 2022

Last Update Submit

October 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in postural sway from baseline to after completion of AMOB

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

    baseline and within 1 month post training

Secondary Outcomes (2)

  • Change in balance confidence from baseline to after completion of AMOB

    baseline and within 1 month post training

  • Change in falls risk from baseline to after completion of AMOB

    baseline and within 1 month post training

Study Arms (1)

A Matter of Balance Program

EXPERIMENTAL
Behavioral: A Matter of Balance: Managing Concerns about Falls

Interventions

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.

A Matter of Balance Program

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe balance disorder diagnosis
  • uncorrected severe vision impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 12, 2023

Study Start

February 8, 2023

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

November 4, 2024

Record last verified: 2023-12

Locations