Vestibular Balance Therapy Intervention for Children (VBT-C)

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.

Study Overview

• Status: Recruiting
• Conditions: Vestibulocochlear Nerve Diseases; Vestibular Disorder; Bilateral Vestibular Loss
• Intervention / Treatment: Other: Vestibular Balance Therapy; Other: Sham Intervention

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 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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael A. Matthews; Phone Number: 205-934-5266; Email: osp@uab.edu
• Study Contact Backup: Name: Jill Meredith; Phone Number: 205-934-4252; Email: jillmeredith@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • UAB
      • Contact: Jennifer B Christy, PhD; Phone Number: 205-934-5903; Email: jbraswel@uab.edu
      • Contact: Connie Bonds; Phone Number: 205-934-5909; Email: bondsc@uab.edu
      • Principal Investigator: Jennifer B Christy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• confirmed diagnosis of severe to profound SNHL
• age 6-12 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VBP Intervention Group; 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; see intervention arm description; Other Names: Vestibular Rehabilitation
Sham Comparator: Sham Intervention; 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; see sham intervention arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process Feasibility (Recruitment Rates)	% of individuals who follow through with enrollment procedures	through study completion at 2 years
Process Feasibility (Refusal Rate Frequency)	Frequency of refusal to participate in the study	through study completion at 2 years
Process Feasibility (Attrition Rates)	% of attrition	through study period at 2 years
Process Feasibility (Retention Rates)	% of retention	through study period at 2 years
Process Feasibility (Completion Rates)	% of participants who complete 80% of intervention sessions	through study period at 2 years
Management Feasibility (training)	time in minutes to train data collectors	through year 1
Management Feasibility (data entry)	time in minutes for data entry	through year 1
Participant Experience Feasibility (Strategies)	participant strategies that helped them with participation in the study (interview)	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)	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)	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)	once, at each participant's final testing session (8 weeks)
Resource Feasibility (frequency)	Frequency of communication with participants	through study period at 2 years
Resource Feasibility (time)	Total time in minutes to communicate with participants	through study period at 2 years

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Foundation for Physical Therapy Research
• Investigators: Principal Investigator: Jennifer B Christy, PhD, University of Alabama at Birmingham

Publications and helpful links

General 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. 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; feasibility; postural control; vestibular rehabilitation; dynamic visual acuity
• Additional Relevant MeSH Terms: Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Cranial Nerve Diseases; Retrocochlear Diseases; Nervous System Diseases; Vestibular Diseases; Bilateral Vestibulopathy; Vestibulocochlear Nerve Diseases
• Other Study ID Numbers: IRB-300010569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI plans to share the data via typical methods such as manuscripts and professional conferences.
• IPD Sharing Time Frame: The data will be shared after study completion and following analysis. The PI may choose to share preliminary data at a conference.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No