Hearing LossNCT05681078
The Impact of Hearing Loss Severity on Balance Intervention Outcomes
A study testing A Matter of Balance: Managing Concerns about Falls in people with Hearing Loss and Fall, run by University of Arkansas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Fall, Postural Balance
- What is being tested?
- A Matter of Balance: Managing Concerns about Falls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe balance disorder diagnosis
- uncorrected severe vision impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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?
Read more
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
- Conditions
- Hearing Loss, Fall, Postural Balance
- Being tested
- A Matter of Balance: Managing Concerns about Falls
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Matter of Balance: Managing Concerns about FallsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A Matter of Balance Program | Experimental | Not described Receives: Behavioral: A Matter of Balance: Managing Concerns about Falls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postural sway from baseline to after completion of AMOB
Postural sway will be assessed using a Balance Tracking Systems pressure plate.
Measured: baseline and within 1 month post training
Secondary outcomes (2)
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.
Measured: baseline and within 1 month post training
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.
Measured: baseline and within 1 month post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start8 Feb 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681078
- Sponsor's protocol ID
- 275305
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2022
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hearing Loss Severity on Balance Intervention Outcomes
- ClinicalTrials.gov ID
- NCT05681078
- Acronym / sponsor ID
- 275305
- Conditions
- Hearing Loss, Fall, Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Matter of Balance Program | Experimental | Behavioral: A Matter of Balance: Managing Concerns about Falls |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- severe balance disorder diagnosis
- uncorrected severe vision impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Matter of Balance: Managing Concerns about FallsA 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. | Behavioural | A Matter of Balance Program |
Primary outcome
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.
2 secondary outcomes
Change in balance confidence from baseline to after completion of AMOB
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Matter of Balance: Managing Concerns about Falls in people with Hearing Loss and Fall, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postural sway from baseline to after completion of AMOB (time frame: baseline and within 1 month post training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.