DeafNCT06912607
Exercise Program for Deaf Seniors to Increase Their Balance and Fitness
A study testing Balance in Motion Exercise class in people with Deaf and Fall, run by Gallaudet University at 1 site in United States.
Trial summary
Deaf older adults 60 years and older are enrolled into an 8-week exercise program delivered in American Sign Language. The class meets twice a week, with handout and video homework. Outcome measures are self-reported balance confidence, lower extremity strength, walking and agility, and standing balance. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Deaf, Fall, American Sign Language
- What is being tested?
- Balance in Motion Exercise class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deaf
- Uses American Sign Language (ASL) fluently
- Community-dwelling
- Able to walk independently for at least 20 ft
- Willing to attend classes twice a week at Gallaudet University
Who cannot join
- Blindness
- Dementia
- Neurological conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Gallaudet University
Washington D.C., District of Columbia, 20002
About this study
Official title: Balance and Fitness Enhancement Program for Deaf Older Adults
Deaf older adults 60 years and older are enrolled into an 8-week exercise program delivered in American Sign Language. The class meets twice a week, with handout and video homework.
Outcome measures are self-reported balance confidence, lower extremity strength, walking and agility, and standing balance. In addition, attendance and keeping up with exercises at home will be tracked.
Read the detailed description
The intervention will be 8 weeks of 2 meetings/wk exercise class, delivered entirely in ASL.
Homework exercise will also be provided.
10-12 participants will be recruited for each of the 4 semesters of offerings.
Physical balance as well as balance confidence will be measured prior to and immediately after the 8-week intervention. In addition, balance confidence will be measured 6-months after the conclusion of the intervention period.
- Conditions
- Deaf, Fall, American Sign Language, Old Age
- Being tested
- Balance in Motion Exercise class
- Keywords
- Exercise, Fall risk, Deaf, Senior citizen, Older adults
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance in Motion Exercise classBehavioural
8 weeks of 2 meetings/wk exercise class, with a once weekly homework exercise, delivered entirely in ASL
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Other | Deaf older adults. Receives: Behavioral: Balance in Motion Exercise class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit-to-Stand
The number of times a person can stand from a chair and sit down, without using hands.
Measured: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
Timed Up-and-Go
The time it takes for a person to stand from a chair, walk 10 ft, turn around, walk back, and sit back down.
Measured: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
Modified Clinical Test of Sensory Integration on Balance
The measure of how steadily a person can stand under 4 conditions (eyes open, on firm surface, eyes closed on firm surface, eyes open on foam, and eyes closed on foam)
Measured: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
Sit and Reach
How far a person can reach beyond their toes. Measure of flexibility.
Measured: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
Activities-specific Balance Confidence scale
A self-report measure of how confident a person is in not falling under various conditions. Reported in 0-100%; higher score means more confidence (better outcome).
Measured: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
Fall Risk Questionnaire
A self-report measure of the number of risk factors a person exhibits. Reported in a scale of 0-14 points; higher score indicates a greater risk (worse outcome).
Measured: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
Secondary outcomes (4)
Attendance rate
How many exercise class sessions, out of 16, a participant attended
Measured: During intervention
Step Count
The number of steps gathered through Fitbit
Measured: During intervention
Effective exercise level
The Active Zone Minutes gathered through Fitbit
Measured: During intervention
Self-reported exercise level
The participant's report on how much time they are spending on exercises
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start5 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gallaudet University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Chizuko Tamaki, AuD, PhD, Principal investigator, Gallaudet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912607
- Sponsor's protocol ID
- IRB-FY24-34
- Other IDs
- 1R15AG087454-01
- Status last verified
- Feb 2026
- First submitted
- 25 Mar 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance and Fitness Enhancement Program for Deaf Older Adults
- ClinicalTrials.gov ID
- NCT06912607
- Acronym / sponsor ID
- IRB-FY24-34
- Conditions
- Deaf, Fall, American Sign Language, Old Age
- Keywords
- Exercise, Fall risk, Deaf, Senior citizen, Older adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gallaudet UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Apr 2025 (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.
Deaf older adults 60 years and older are enrolled into an 8-week exercise program delivered in American Sign Language. The class meets twice a week, with handout and video homework.
Outcome measures are self-reported balance confidence, lower extremity strength, walking and agility, and standing balance. In addition, attendance and keeping up with exercises at home will be tracked.
Detailed description
The intervention will be 8 weeks of 2 meetings/wk exercise class, delivered entirely in ASL.
Homework exercise will also be provided.
10-12 participants will be recruited for each of the 4 semesters of offerings.
Physical balance as well as balance confidence will be measured prior to and immediately after the 8-week intervention. In addition, balance confidence will be measured 6-months after the conclusion of the intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Other | Behavioral: Balance in Motion Exercise classDeaf older adults. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Deaf
- Uses American Sign Language (ASL) fluently
- Community-dwelling
- Able to walk independently for at least 20 ft
- Willing to attend classes twice a week at Gallaudet University
Key exclusion criteria (3 listed)
- Blindness
- Dementia
- Neurological conditions
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 |
|---|---|---|
| Balance in Motion Exercise class8 weeks of 2 meetings/wk exercise class, with a once weekly homework exercise, delivered entirely in ASL | Behavioural | Single Group |
Primary outcome
Sit-to-Stand
Time frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
The number of times a person can stand from a chair and sit down, without using hands.
Timed Up-and-Go
Time frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
The time it takes for a person to stand from a chair, walk 10 ft, turn around, walk back, and sit back down.
Modified Clinical Test of Sensory Integration on Balance
Time frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
The measure of how steadily a person can stand under 4 conditions (eyes open, on firm surface, eyes closed on firm surface, eyes open on foam, and eyes closed on foam)
Sit and Reach
Time frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention
How far a person can reach beyond their toes. Measure of flexibility.
Activities-specific Balance Confidence scale
Time frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
A self-report measure of how confident a person is in not falling under various conditions. Reported in 0-100%; higher score means more confidence (better outcome).
Fall Risk Questionnaire
Time frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention, 6 months after intervention
A self-report measure of the number of risk factors a person exhibits. Reported in a scale of 0-14 points; higher score indicates a greater risk (worse outcome).
4 secondary outcomes
Attendance rate
Time frame: During intervention
Step Count
Time frame: During intervention
Effective exercise level
Time frame: During intervention
Self-reported exercise level
Time frame: 6 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Deaf
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome
Not yet recruiting
SENSE-Brain Health Pro for Older Adults With Sensory Loss
Vision and Hearing Loss, Vision Impairment
Not yet recruitingPhase 2
Study to Evaluate the Long-Term Safety of Ultevursen in Participants With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene
Retinitis Pigmentosa (RP), Usher Syndrome Type 2
Not yet recruiting
Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
Hearing Impaired Children
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.
Chizuko Tamaki, AuD, PhD principal investigator
Gallaudet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance in Motion Exercise class in people with Deaf and Fall, run by Gallaudet University 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sit-to-Stand (time frame: 1 - 21 days before the start of intervention; within 2 weeks of the end of intervention). The study lists 6 primary outcomes in all. 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 19 Feb 2026.