Study Summary
This trial tests the feasability of a home-based balance therapy program for kids with vestibular hypofunction. Tests, an 8-week home-based intv. & weekly checks from PTs will be used to design a larger trial w/a comparison group.
- Vestibular Disorder
- Bilateral Vestibulopathy
- Vestibulocochlear Nerve Disease
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
3 Primary · 13 Secondary · Reporting Duration: through study period at 2 years
Trial Safety
Trial Design
2 Treatment Groups
VBP Intervention Group
1 of 2
Sham Intervention
1 of 2
Experimental Treatment
Non-Treatment Group
15 Total Participants · 2 Treatment Groups
Primary Treatment: VBP Intervention Group · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 6 - 12 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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. Erratum In: Pediatr Phys Ther. 2015 Spring;27(1):102.
- Rine 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.
- Rine 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.
- Braswell 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.
- Jennifer Braswell Christy 2023. "Vestibular Balance Therapy Intervention for Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741515.
Frequently Asked Questions
Is this research project accessible to individuals under 35 years of age?
"Candidates for the trial should be between the ages of 6 and 12 years old." - Anonymous Online Contributor
Are any new participants being accepted for this clinical trial?
"As per the clinicaltrials.gov website, this trial is not in need of new participants at this time; having been first posted on March 1st 2023 and last updated on February 22nd 2023. However, there are currently 159 other medical trials actively looking for enrollees." - Anonymous Online Contributor
What goals does this clinical trial seek to accomplish?
"Evaluating over a pre-test, midpoint, and post-test period of 4 weeks and 8 weeks respectively, the main outcome measure for this trial is Change in Functional Gait Assessment at both time points. Secondary metrics include Refusal Rate Frequency (Frequency of refusal to participate), Attrition Rates (% of attrition) ,and Retention Rates (% retention)." - Anonymous Online Contributor
Who can be accepted as participants in this trial?
"This clinical trial is presently enrolling 15 children aged 6-12 years old with vestibulocochlear nerve affliction. In order to be accepted, participants must have a confirmed diagnosis of severe to profound SNHL, an up-to-date vision screening/testing (or the willingness to get one), and their parent or guardian's verbal commitment towards either home vestibular balance therapy or sham intervention." - Anonymous Online Contributor