Vestibulocochlear Nerve DiseasesVBT-CNCT05741515
Vestibular Balance Therapy Intervention for Children
A study testing Vestibular Balance Therapy in people with Vestibulocochlear Nerve Diseases and Vestibular Disorder, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of this within groups clinical trial is to determine the feasibility of a home-based vestibular balance therapy program for children with vestibular hypofunction. The main questions to be answered are: 1) what is the intervention's feasibility and 2) what is the intervention's preliminary impact on function?… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Vestibulocochlear Nerve Diseases, Vestibular Disorder, Bilateral Vestibular Loss
- What is being tested?
- Vestibular Balance Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2023to 18 Aug 2025
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- confirmed diagnosis of severe to profound SNHL
- age 4-17 years
- caregiver/child verbal willingness to commit to the home vestibular balance therapy or sham intervention
- vision screening/testing within 1 year or willingness to get a vision test.
Who cannot join
- neurologic condition other than SNHL
- inability to read at a kindergarten level or identify pictures
- currently receiving vestibular therapy
- uncorrected vision problems unrelated to a vestibular deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction
The goal of this within groups clinical trial is to determine the feasibility of a home-based vestibular balance therapy program for children with vestibular hypofunction. The main questions to be answered are: 1) what is the intervention's feasibility and 2) what is the intervention's preliminary impact on function? Participants will receive a comprehensive battery of vestibular function and balance tests, then an 8-week home-based intervention to be done 5 times/week with weekly checks from the physical therapist. Data will be used to design a larger clinical trial with a comparison group.
Read the detailed description
Approximately 60-75% of children with severe/profound sensorineural hearing loss (SNHL) also have vestibular hypofunction (VH), resulting in delayed gross motor development, poor postural control, and gaze instability. Although clinical practice guidelines provide recommendations for adults with VH, no statements exist for children due to a paucity of high- level studies. The long-term objective of this proposal is to assess feasibility of a home-based vestibular balance therapy (VBT) program for children so that a larger well-powered controlled study can be designed. The specific aims are to assess the intervention's feasibility (Aim 1), estimate its preliminary impact on functional outcomes (Aim 2), and assess participant engagement (secondary Aim). To accomplish this, we will use a prospective single arm feasibility design. We will enroll 15 children with SNHL, aged 4-17 years; 12 with confirmed VH for the VBT, and 3 with normal vestibular function to test the sham intervention. All children will be tested on the functional outcomes: computerized dynamic visual acuity, modified functional gait assessment, and sensory organization test at baseline, 4, and 8 weeks. A physical therapist (PT) will train children/caregivers in the 8-week structured VBT home program consisting of 4 categories of exercises (Times 1 viewing, gaze shifting, static and dynamic balance) done 5 times/week, 5 minutes/exercise. The PT will meet weekly with the child/caregiver in person to systematically progress the exercises. The children in the sham intervention (10 minutes of reading, 10 minutes of play) will also receive weekly meetings with the PT to control for attention bias. To assess Aim 1 (Feasibility) metrics will include process (e.g., recruitment rates), resources (e.g., communication needs), management (e.g., data collection/entry), experience (e.g., barriers). To assess Aim 2 (impact) we will analyze within group changes and effect sizes to design the larger study.
- Being tested
- Vestibular Balance Therapy, Sham Intervention
- Keywords
- pediatric, vestibular rehabilitation, dynamic visual acuity, postural control, feasibility
- Medical subject headings
- Vestibulocochlear Nerve Diseases, Vestibular Diseases, Bilateral Vestibulopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Balance TherapyOther
Also called Vestibular Rehabilitation
see intervention arm description
Sham InterventionOther
see sham intervention arm description
| Study group | Role | What they receive |
|---|---|---|
| VBP Intervention Group | Experimental | Children coded as abnormal on functional tests (FT) (n=12) will participate in an 8-week 5X/week home-based VBT program. At the initial visit (T0), the PI will instruct the participants (caregiver and child) in the program and provide all materials. The exercises will be led by the caregiver, with weekly in person checks by the PI to progress and provide coaching. The child/caregiver will complete a daily log to report activities and level of enjoyment. VBT will be done 5 days/week and will include 4 key categories of exercises, each lasting 5 minutes (20 minutes total of exercise per day). The 4 categories, explained below, include: 1) Times 1 (X1) Viewing, 2) Gaze Shifting, 3) Static Balance, 4) Dynamic Balance. The proposed VBT home program will include 10 minutes of gaze stabilization exercises, and 10 minutes of balance training. Receives: Other: Vestibular Balance Therapy |
| Sham Intervention | Sham comparator | Sham Intervention (not to be compared to intervention - for feasibility only):
Aim 1 is to establish the feasibility of a control intervention to be used in future studies. Therefore, 3 participants who score above the set criterion for the Functional Tests (FT) (i.e., they do not need VBT) will participate in an 8-week sham intervention. At T0, the PI will instruct the participants to do the sham intervention, led by the caregiver with weekly checks to control for attention bias. The sham intervention will be done for 20 minutes per day and will consist of 10 minutes of focused reading a book of the child's choice and 10 minutes of active play. The child and caregiver will complete a daily activity log documenting the activity and level of enjoyment. Receives: Other: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks
Difference in visual acuity with the head stationary versus moving
Measured: Baseline (pre), 4 weeks (mid), 8 weeks (post)
Change in Functional Gait Assessment at 4 and 8 weeks
A standardized test of dynamic balance
Measured: Baseline (pre), 4 weeks (mid), 8 weeks (post)
Change in Sensory Organization Test at 4 and 8 weeks
A standardized test of static postural control
Measured: Baseline (pre), 4 weeks (mid), 8 weeks (post)
Secondary outcomes (13)
Process Feasibility (Recruitment Rates)
% of individuals who follow through with enrollment procedures
Measured: through study completion at 2 years
Process Feasibility (Refusal Rate Frequency)
Frequency of refusal to participate in the study
Measured: through study completion at 2 years
Process Feasibility (Attrition Rates)
% of attrition
Measured: through study period at 2 years
Process Feasibility (Retention Rates)
% of retention
Measured: through study period at 2 years
Process Feasibility (Completion Rates)
% of participants who complete 80% of intervention sessions
Measured: through study period at 2 years
Management Feasibility (training)
time in minutes to train data collectors
Measured: through year 1
Management Feasibility (data entry)
time in minutes for data entry
Measured: through year 1
Participant Experience Feasibility (Strategies)
participant strategies that helped them with participation in the study (interview)
Measured: through study period at 2 years
Participant Experience Feasibility (Enjoyment)
Enjoyment level for each participant (ordinal scale of 0=no enjoyment to 10=extreme enjoyment)
Measured: through the study period at 2 years
Participant Experience Feasibility (Testing Difficulty)
Participants will rate the level of difficulty of the initial testing session (0=not difficult to 10=extreme difficulty)
Measured: baseline only - initial testing session
Participant Experience Feasibility (Intervention Difficulty)
Participants will rate the level of difficulty of the overall intervention (0=not difficult to 10=extreme difficulty)
Measured: once, at each participant's final testing session (8 weeks)
Resource Feasibility (frequency)
Frequency of communication with participants
Measured: through study period at 2 years
Resource Feasibility (time)
Total time in minutes to communicate with participants
Measured: through study period at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start28 Mar 2023
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vestibulocochlear Nerve DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective single arm feasibility clinical trial. We will also enroll 3 children in a control intervention group, but these will be children without the condition, to determine the feasibility of the control intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Responsible party
- Principal investigator, Jennifer Braswell Christy, University of Alabama at Birmingham
- Investigators
- Jennifer B Christy, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741515
- Sponsor's protocol ID
- IRB-300010569
- Other IDs
- Foundation for PT Research
- Acronym
- VBT-C
- Status last verified
- May 2026
- First submitted
- 25 Jan 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI plans to share the data via typical methods such as manuscripts and professional conferences.
Publications
Christy JB, Payne J, Azuero A, Formby C. Reliability and diagnostic accuracy of clinical tests of vestibular function for children. Pediatr Phys Ther. 2014 Summer;26(2):180-9. doi: 10.1097/PEP.0000000000000039.
PubMed 24675116Rine RM, Braswell J. A clinical test of dynamic visual acuity for children. Int J Pediatr Otorhinolaryngol. 2003 Nov;67(11):1195-201. doi: 10.1016/j.ijporl.2003.07.004.
PubMed 14597370Rine RM, Braswell J, Fisher D, Joyce K, Kalar K, Shaffer M. Improvement of motor development and postural control following intervention in children with sensorineural hearing loss and vestibular impairment. Int J Pediatr Otorhinolaryngol. 2004 Sep;68(9):1141-8. doi: 10.1016/j.ijporl.2004.04.007.
PubMed 15302144Braswell J, Rine RM. Preliminary evidence of improved gaze stability following exercise in two children with vestibular hypofunction. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1967-73. doi: 10.1016/j.ijporl.2006.06.010. Epub 2006 Oct 4.
PubMed 17023057
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction
- ClinicalTrials.gov ID
- NCT05741515
- Acronym / sponsor ID
- VBT-C / IRB-300010569
- Keywords
- pediatric, vestibular rehabilitation, dynamic visual acuity, postural control, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy Research
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 23 Feb 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 within groups clinical trial is to determine the feasibility of a home-based vestibular balance therapy program for children with vestibular hypofunction. The main questions to be answered are: 1) what is the intervention's feasibility and 2) what is the intervention's preliminary impact on function? Participants will receive a comprehensive battery of vestibular function and balance tests, then an 8-week home-based intervention to be done 5 times/week with weekly checks from the physical therapist. Data will be used to design a larger clinical trial with a comparison group.
Detailed description
Approximately 60-75% of children with severe/profound sensorineural hearing loss (SNHL) also have vestibular hypofunction (VH), resulting in delayed gross motor development, poor postural control, and gaze instability. Although clinical practice guidelines provide recommendations for adults with VH, no statements exist for children due to a paucity of high- level studies. The long-term objective of this proposal is to assess feasibility of a home-based vestibular balance therapy (VBT) program for children so that a larger well-powered controlled study can be designed. The specific aims are to assess the intervention's feasibility (Aim 1), estimate its preliminary impact on functional outcomes (Aim 2), and assess participant engagement (secondary Aim). To accomplish this, we will use a prospective single arm feasibility design. We will enroll 15 children with SNHL, aged 4-17 years; 12 with confirmed VH for the VBT, and 3 with normal vestibular function to test the sham intervention. All children will be tested on the functional outcomes: computerized dynamic visual acuity, modified functional gait assessment, and sensory organization test at baseline, 4, and 8 weeks. A physical therapist (PT) will train children/caregivers in the 8-week structured VBT home program consisting of 4 categories of exercises (Times 1 viewing, gaze shifting, static and dynamic balance) done 5 times/week, 5 minutes/exercise. The PT will meet weekly with the child/caregiver in person to systematically progress the exercises. The children in the sham intervention (10 minutes of reading, 10 minutes of play) will also receive weekly meetings with the PT to control for attention bias. To assess Aim 1 (Feasibility) metrics will include process (e.g., recruitment rates), resources (e.g., communication needs), management (e.g., data collection/entry), experience (e.g., barriers). To assess Aim 2 (impact) we will analyze within group changes and effect sizes to design the larger study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective single arm feasibility clinical trial. We will also enroll 3 children in a control intervention group, but these will be children without the condition, to determine the feasibility of the control intervention.
| Arm | Type | Receives |
|---|---|---|
| VBP Intervention Group | Experimental | Other: Vestibular Balance TherapyChildren coded as abnormal on functional tests (FT) (n=12) will participate in an 8-week 5X/week home-based VBT program. At the initial visit (T0), the PI will instruct the participants (caregiver and child) in the program and provide all materials. The exercises will be led by the caregiver, with weekly in person checks by the PI to progress and provide coaching. The child/caregiver will complete a daily log to report activities and level of enjoyment. VBT will be done 5 days/week and will include 4 key categories of exercises, each lasting 5 minutes (20 minutes total of exercise per day). The 4 categories, explained below, include: 1) Times 1 (X1) Viewing, 2) Gaze Shifting, 3) Static Balance, 4) Dynamic Balance. The proposed VBT home program will include 10 minutes of gaze stabilization exercises, and 10 minutes of balance training. |
| Sham Intervention | Sham comparator | Other: Sham InterventionSham Intervention (not to be compared to intervention - for feasibility only): Aim 1 is to establish the feasibility of a control intervention to be used in future studies. Therefore, 3 participants who score above the set criterion for the Functional Tests (FT) (i.e., they do not need VBT) will participate in an 8-week sham intervention. At T0, the PI will instruct the participants to do the sham intervention, led by the caregiver with weekly checks to control for attention bias. The sham intervention will be done for 20 minutes per day and will consist of 10 minutes of focused reading a book of the child's choice and 10 minutes of active play. The child and caregiver will complete a daily activity log documenting the activity and level of enjoyment. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- confirmed diagnosis of severe to profound SNHL
- age 4-17 years
- caregiver/child verbal willingness to commit to the home vestibular balance therapy or sham intervention
- vision screening/testing within 1 year or willingness to get a vision test.
Key exclusion criteria (4 listed)
- neurologic condition other than SNHL
- inability to read at a kindergarten level or identify pictures
- currently receiving vestibular therapy
- uncorrected vision problems unrelated to a vestibular deficit
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 |
|---|---|---|
| Vestibular Balance TherapyAlso: Vestibular Rehabilitationsee intervention arm description | Other | VBP Intervention Group |
| Sham Interventionsee sham intervention arm description | Other | Sham Intervention |
Primary outcome
Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks
Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
Difference in visual acuity with the head stationary versus moving
Change in Functional Gait Assessment at 4 and 8 weeks
Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
A standardized test of dynamic balance
Change in Sensory Organization Test at 4 and 8 weeks
Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
A standardized test of static postural control
13 secondary outcomes
Process Feasibility (Recruitment Rates)
Time frame: through study completion at 2 years
Process Feasibility (Refusal Rate Frequency)
Time frame: through study completion at 2 years
Process Feasibility (Attrition Rates)
Time frame: through study period at 2 years
Process Feasibility (Retention Rates)
Time frame: through study period at 2 years
Process Feasibility (Completion Rates)
Time frame: through study period at 2 years
Management Feasibility (training)
Time frame: through year 1
Management Feasibility (data entry)
Time frame: through year 1
Participant Experience Feasibility (Strategies)
Time frame: through study period at 2 years
Participant Experience Feasibility (Enjoyment)
Time frame: through the study period at 2 years
Participant Experience Feasibility (Testing Difficulty)
Time frame: baseline only - initial testing session
Participant Experience Feasibility (Intervention Difficulty)
Time frame: once, at each participant's final testing session (8 weeks)
Resource Feasibility (frequency)
Time frame: through study period at 2 years
Resource Feasibility (time)
Time frame: through study period at 2 years
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 18 May 2026.
- Background: PubMed 24675116Christy JB, Payne J, Azuero A, Formby C. Reliability and diagnostic accuracy of clinical tests of vestibular function for children. Pediatr Phys Ther. 2014 Summer;26(2):180-9. doi: 10.1097/PEP.0000000000000039.
- Background: PubMed 14597370Rine RM, Braswell J. A clinical test of dynamic visual acuity for children. Int J Pediatr Otorhinolaryngol. 2003 Nov;67(11):1195-201. doi: 10.1016/j.ijporl.2003.07.004.
- Background: PubMed 15302144Rine RM, Braswell J, Fisher D, Joyce K, Kalar K, Shaffer M. Improvement of motor development and postural control following intervention in children with sensorineural hearing loss and vestibular impairment. Int J Pediatr Otorhinolaryngol. 2004 Sep;68(9):1141-8. doi: 10.1016/j.ijporl.2004.04.007.
- Background: PubMed 17023057Braswell J, Rine RM. Preliminary evidence of improved gaze stability following exercise in two children with vestibular hypofunction. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1967-73. doi: 10.1016/j.ijporl.2006.06.010. Epub 2006 Oct 4.
- Individual participant dataSharing planned: Yes. The PI plans to share the data via typical methods such as manuscripts and professional conferences.
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.
Jennifer B Christy, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Balance Therapy in people with Vestibulocochlear Nerve Diseases and Vestibular Disorder, run by University of Alabama at Birmingham 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 4 inclusion and 4 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 18 May 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. Some participants in this study may receive a placebo. 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 Computerized Dynamic Visual Acuity at 4 and 8 weeks (time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741515, which also lists 4 linked publications.
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 18 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.