Clinical Trials Logo

Clinical 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? 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.


Clinical Trial 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 6-12 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


Related Conditions & MeSH terms


NCT number NCT05741515
Study type Interventional
Source University of Alabama at Birmingham
Contact Michael A. Matthews
Phone 205-934-5266
Email osp@uab.edu
Status Recruiting
Phase N/A
Start date March 28, 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Recruiting NCT04353115 - A Serious Game to Rehabilitate Gaze Stability in Children With Vestibular Deficit
Recruiting NCT04053829 - Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Active, not recruiting NCT04479761 - Sensory Integration of Auditory and Visual Cues in Diverse Contexts N/A
Recruiting NCT03624283 - Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV N/A
Recruiting NCT03690817 - Hearing Loss, Vestibular Loss and Cognitive Performance
Completed NCT03555370 - Vestibular Treatment in Adolescents Following Sport Related Concussion N/A
Not yet recruiting NCT05322538 - Menier's Disease - Bone Density Study N/A
Completed NCT05795530 - Vestibular Function in Cochlear Implants
Completed NCT03330262 - Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability N/A
Not yet recruiting NCT06177132 - Vestibular Infant Screening - Rehabilitation N/A
Completed NCT03952936 - Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study N/A
Recruiting NCT05436067 - Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements N/A
Completed NCT03951584 - Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Recruiting NCT06407726 - Comparative Effects of Virtual Reality and Vestibular Exercises on Balance Gait in Older Adults N/A
Active, not recruiting NCT05793216 - VestibulOTherapy: Vestibular Impact on Learning N/A
Recruiting NCT04851184 - Dose of Vestibular Rehabilitation for Vestibular Hypofunction N/A
Not yet recruiting NCT06300840 - Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH) N/A