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Completed

NCT Number: NCT05741515

Vestibular Balance Therapy Intervention for Children

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.

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Key information

About this study

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 4-17 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Vestibular Balance Therapy

Other

see intervention arm description

Other names: Vestibular Rehabilitation

Sham intervention

Other

see sham intervention arm description

Primary outcomes

  1. Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks

    Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)

    Difference in visual acuity with the head stationary versus moving

  2. Change in Functional Gait Assessment at 4 and 8 weeks

    Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)

    A standardized test of dynamic balance

  3. Change in Sensory Organization Test at 4 and 8 weeks

    Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)

    A standardized test of static postural control

Secondary outcomes

  1. Process Feasibility (Recruitment Rates)

    Time frame: through study completion at 2 years

    % of individuals who follow through with enrollment procedures

  2. Process Feasibility (Refusal Rate Frequency)

    Time frame: through study completion at 2 years

    Frequency of refusal to participate in the study

  3. Process Feasibility (Attrition Rates)

    Time frame: through study period at 2 years

    % of attrition

  4. Process Feasibility (Retention Rates)

    Time frame: through study period at 2 years

    % of retention

  5. Process Feasibility (Completion Rates)

    Time frame: through study period at 2 years

    % of participants who complete 80% of intervention sessions

  6. Management Feasibility (training)

    Time frame: through year 1

    time in minutes to train data collectors

  7. Management Feasibility (data entry)

    Time frame: through year 1

    time in minutes for data entry

  8. Participant Experience Feasibility (Strategies)

    Time frame: through study period at 2 years

    participant strategies that helped them with participation in the study (interview)

  9. Participant Experience Feasibility (Enjoyment)

    Time frame: through the study period at 2 years

    Enjoyment level for each participant (ordinal scale of 0=no enjoyment to 10=extreme enjoyment)

  10. Participant Experience Feasibility (Testing Difficulty)

    Time frame: baseline only - initial testing session

    Participants will rate the level of difficulty of the initial testing session (0=not difficult to 10=extreme difficulty)

  11. Participant Experience Feasibility (Intervention Difficulty)

    Time frame: once, at each participant's final testing session (8 weeks)

    Participants will rate the level of difficulty of the overall intervention (0=not difficult to 10=extreme difficulty)

  12. Resource Feasibility (frequency)

    Time frame: through study period at 2 years

    Frequency of communication with participants

  13. Resource Feasibility (time)

    Time frame: through study period at 2 years

    Total time in minutes to communicate with participants

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Foundation for Physical Therapy Research

Registry information

Official study title

Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction

Acronym: VBT-C

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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