Clinical trial NCT05741515: Vestibular Balance Therapy Intervention for Children
Official title: Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibulocochlear Nerve Diseases
Vestibular Disorder
Bilateral Vestibular Loss
Keywords: pediatric
vestibular rehabilitation
dynamic visual acuity
postural control
feasibility
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy Research
First posted: 2023-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks
timeFrame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
measure: Change in Functional Gait Assessment at 4 and 8 weeks
timeFrame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
measure: Change in Sensory Organization Test at 4 and 8 weeks
timeFrame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
Secondary outcomes:
measure: Process Feasibility (Recruitment Rates)
timeFrame: through study completion at 2 years
measure: Process Feasibility (Refusal Rate Frequency)
timeFrame: through study completion at 2 years
measure: Process Feasibility (Attrition Rates)
timeFrame: through study period at 2 years
measure: Process Feasibility (Retention Rates)
timeFrame: through study period at 2 years
measure: Process Feasibility (Completion Rates)
timeFrame: through study period at 2 years
measure: Management Feasibility (training)
timeFrame: through year 1
measure: Management Feasibility (data entry)
timeFrame: through year 1
measure: Participant Experience Feasibility (Strategies)
timeFrame: through study period at 2 years
measure: Participant Experience Feasibility (Enjoyment)
timeFrame: through the study period at 2 years
measure: Participant Experience Feasibility (Testing Difficulty)
timeFrame: baseline only - initial testing session
measure: Participant Experience Feasibility (Intervention Difficulty)
timeFrame: once, at each participant's final testing session (8 weeks)
measure: Resource Feasibility (frequency)
timeFrame: through study period at 2 years
measure: Resource Feasibility (time)
timeFrame: through study period at 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jennifer B Christy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.