Bilateral Vestibular Loss, Vestibular Disorder, Vestibulocochlear Nerve Diseases
Conditions
Keywords
pediatric, vestibular rehabilitation, dynamic visual acuity, postural control, feasibility
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.
Interventions
OTHERVestibular Balance Therapy
see intervention arm description
OTHERSham Intervention
see sham intervention arm description
Sponsors
University of Alabama at Birmingham
Foundation for Physical Therapy Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinicians doing the functional outcome measures (FGA, DVA, SOT) will not know the result of the vestibular function tests.
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Computerized Dynamic Visual Acuity at 4 and 8 weeks | Baseline (pre), 4 weeks (mid), 8 weeks (post) | Difference in visual acuity with the head stationary versus moving |
| Change in Functional Gait Assessment at 4 and 8 weeks | Baseline (pre), 4 weeks (mid), 8 weeks (post) | A standardized test of dynamic balance |
| Change in Sensory Organization Test at 4 and 8 weeks | Baseline (pre), 4 weeks (mid), 8 weeks (post) | A standardized test of static postural control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Process Feasibility (Recruitment Rates) | through study completion at 2 years | % of individuals who follow through with enrollment procedures |
| Process Feasibility (Refusal Rate Frequency) | through study completion at 2 years | Frequency of refusal to participate in the study |
| Process Feasibility (Attrition Rates) | through study period at 2 years | % of attrition |
| Process Feasibility (Retention Rates) | through study period at 2 years | % of retention |
| Process Feasibility (Completion Rates) | through study period at 2 years | % of participants who complete 80% of intervention sessions |
| Management Feasibility (training) | through year 1 | time in minutes to train data collectors |
| Management Feasibility (data entry) | through year 1 | time in minutes for data entry |
| Participant Experience Feasibility (Strategies) | through study period at 2 years | participant strategies that helped them with participation in the study (interview) |
| Participant Experience Feasibility (Enjoyment) | through the study period at 2 years | Enjoyment level for each participant (ordinal scale of 0=no enjoyment to 10=extreme enjoyment) |
| Participant Experience Feasibility (Testing Difficulty) | baseline only - initial testing session | Participants will rate the level of difficulty of the initial testing session (0=not difficult to 10=extreme difficulty) |
| Participant Experience Feasibility (Intervention Difficulty) | 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) |
| Resource Feasibility (frequency) | through study period at 2 years | Frequency of communication with participants |
| Resource Feasibility (time) | through study period at 2 years | Total time in minutes to communicate with participants |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer B Christy, PhD
University of Alabama at Birmingham
Outcome results
None listed