Vestibular Balance Therapy Intervention for Children

NCT05741515 | Completed

• 1 other identifier: IRB-300010569
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vestibular Disorder; Bilateral Vestibular Loss; Vestibulocochlear Nerve Diseases

Keywords

pediatric; vestibular rehabilitation; dynamic visual acuity; postural control; feasibility

Outcome Measures

Primary Outcomes (3)

• Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks

  Difference in visual acuity with the head stationary versus moving

  Baseline (pre), 4 weeks (mid), 8 weeks (post)

• Change in Functional Gait Assessment at 4 and 8 weeks

  A standardized test of dynamic balance

  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

  Baseline (pre), 4 weeks (mid), 8 weeks (post)

Secondary Outcomes (13)

• Process Feasibility (Recruitment Rates)

  through study completion at 2 years

• Process Feasibility (Refusal Rate Frequency)

  through study completion at 2 years

• Process Feasibility (Attrition Rates)

  through study period at 2 years

• Process Feasibility (Retention Rates)

  through study period at 2 years

• Process Feasibility (Completion Rates)

  through study period at 2 years

Study Arms (2)

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.

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.

Other: Sham Intervention

Interventions

Sham Intervention OTHER

see sham intervention arm description

Sham Intervention

Vestibular Balance Therapy OTHER

see intervention arm description

Also known as: Vestibular Rehabilitation

VBP Intervention Group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Physical Therapy Research: collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (4)

• 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.

  PMID: 24675116 BACKGROUND

• 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.

  PMID: 14597370 BACKGROUND

• 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.

  PMID: 15302144 BACKGROUND

• 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.

  PMID: 17023057 BACKGROUND

MeSH Terms

Conditions

Vestibulocochlear Nerve Diseases; Vestibular Diseases; Bilateral Vestibulopathy

Condition Hierarchy (Ancestors)

Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Labyrinth Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer B Christy, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinicians doing the functional outcome measures (FGA, DVA, SOT) will not know the result of the vestibular function tests.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 23, 2023
• Study Start: March 28, 2023
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be shared after study completion and following analysis. The PI may choose to share preliminary data at a conference.

Locations

US (1)