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Vestibular Balance Therapy Intervention for Children (VBT-C)

Primary Purpose

Vestibulocochlear Nerve Diseases, Vestibular Disorder, Bilateral Vestibular Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Balance Therapy
Sham Intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibulocochlear Nerve Diseases focused on measuring pediatric, vestibular rehabilitation, dynamic visual acuity, postural control, feasibility

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UABRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

VBP Intervention Group

Sham Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks
Difference in visual acuity with the head stationary versus moving
Change in Functional Gait Assessment at 4 and 8 weeks
A standardized test of dynamic balance
Change in Sensory Organization Test at 4 and 8 weeks
A standardized test of static postural control

Secondary Outcome Measures

Process Feasibility (Recruitment Rates)
% of individuals who follow through with enrollment procedures
Process Feasibility (Refusal Rate Frequency)
Frequency of refusal to participate in the study
Process Feasibility (Attrition Rates)
% of attrition
Process Feasibility (Retention Rates)
% of retention
Process Feasibility (Completion Rates)
% of participants who complete 80% of intervention sessions
Management Feasibility (training)
time in minutes to train data collectors
Management Feasibility (data entry)
time in minutes for data entry
Participant Experience Feasibility (Strategies)
participant strategies that helped them with participation in the study (interview)
Participant Experience Feasibility (Enjoyment)
Enjoyment level for each participant (ordinal scale of 0=no enjoyment to 10=extreme enjoyment)
Participant Experience Feasibility (Testing Difficulty)
Participants will rate the level of difficulty of the initial testing session (0=not difficult to 10=extreme difficulty)
Participant Experience Feasibility (Intervention Difficulty)
Participants will rate the level of difficulty of the overall intervention (0=not difficult to 10=extreme difficulty)
Resource Feasibility (frequency)
Frequency of communication with participants
Resource Feasibility (time)
Total time in minutes to communicate with participants

Full Information

First Posted
January 25, 2023
Last Updated
March 28, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Foundation for Physical Therapy Research
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1. Study Identification

Unique Protocol Identification Number
NCT05741515
Brief Title
Vestibular Balance Therapy Intervention for Children
Acronym
VBT-C
Official Title
Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Foundation for Physical Therapy Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibulocochlear Nerve Diseases, Vestibular Disorder, Bilateral Vestibular Loss
Keywords
pediatric, vestibular rehabilitation, dynamic visual acuity, postural control, feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The clinicians doing the functional outcome measures (FGA, DVA, SOT) will not know the result of the vestibular function tests.
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VBP Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Intervention
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vestibular Balance Therapy
Other Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
see intervention arm description
Intervention Type
Other
Intervention Name(s)
Sham Intervention
Intervention Description
see sham intervention arm description
Primary Outcome Measure Information:
Title
Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks
Description
Difference in visual acuity with the head stationary versus moving
Time Frame
Baseline (pre), 4 weeks (mid), 8 weeks (post)
Title
Change in Functional Gait Assessment at 4 and 8 weeks
Description
A standardized test of dynamic balance
Time Frame
Baseline (pre), 4 weeks (mid), 8 weeks (post)
Title
Change in Sensory Organization Test at 4 and 8 weeks
Description
A standardized test of static postural control
Time Frame
Baseline (pre), 4 weeks (mid), 8 weeks (post)
Secondary Outcome Measure Information:
Title
Process Feasibility (Recruitment Rates)
Description
% of individuals who follow through with enrollment procedures
Time Frame
through study completion at 2 years
Title
Process Feasibility (Refusal Rate Frequency)
Description
Frequency of refusal to participate in the study
Time Frame
through study completion at 2 years
Title
Process Feasibility (Attrition Rates)
Description
% of attrition
Time Frame
through study period at 2 years
Title
Process Feasibility (Retention Rates)
Description
% of retention
Time Frame
through study period at 2 years
Title
Process Feasibility (Completion Rates)
Description
% of participants who complete 80% of intervention sessions
Time Frame
through study period at 2 years
Title
Management Feasibility (training)
Description
time in minutes to train data collectors
Time Frame
through year 1
Title
Management Feasibility (data entry)
Description
time in minutes for data entry
Time Frame
through year 1
Title
Participant Experience Feasibility (Strategies)
Description
participant strategies that helped them with participation in the study (interview)
Time Frame
through study period at 2 years
Title
Participant Experience Feasibility (Enjoyment)
Description
Enjoyment level for each participant (ordinal scale of 0=no enjoyment to 10=extreme enjoyment)
Time Frame
through the study period at 2 years
Title
Participant Experience Feasibility (Testing Difficulty)
Description
Participants will rate the level of difficulty of the initial testing session (0=not difficult to 10=extreme difficulty)
Time Frame
baseline only - initial testing session
Title
Participant Experience Feasibility (Intervention Difficulty)
Description
Participants will rate the level of difficulty of the overall intervention (0=not difficult to 10=extreme difficulty)
Time Frame
once, at each participant's final testing session (8 weeks)
Title
Resource Feasibility (frequency)
Description
Frequency of communication with participants
Time Frame
through study period at 2 years
Title
Resource Feasibility (time)
Description
Total time in minutes to communicate with participants
Time Frame
through study period at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A. Matthews
Phone
205-934-5266
Email
osp@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Meredith
Phone
205-934-4252
Email
jillmeredith@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer B Christy, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer B Christy, PhD
Phone
205-934-5903
Email
jbraswel@uab.edu
First Name & Middle Initial & Last Name & Degree
Connie Bonds
Phone
205-934-5909
Email
bondsc@uab.edu
First Name & Middle Initial & Last Name & Degree
Jennifer B Christy, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
24675116
Citation
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.
Results Reference
background
PubMed Identifier
14597370
Citation
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.
Results Reference
background
PubMed Identifier
15302144
Citation
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.
Results Reference
background
PubMed Identifier
17023057
Citation
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.
Results Reference
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Vestibular Balance Therapy Intervention for Children

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