UAB
Birmingham, Alabama, 35294, United States
NCT Number: NCT05741515
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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Notify Me4 year–17 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
see intervention arm description
Other names: Vestibular Rehabilitation
see sham intervention arm description
Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
Difference in visual acuity with the head stationary versus moving
Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
A standardized test of dynamic balance
Time frame: Baseline (pre), 4 weeks (mid), 8 weeks (post)
A standardized test of static postural control
Time frame: through study completion at 2 years
% of individuals who follow through with enrollment procedures
Time frame: through study completion at 2 years
Frequency of refusal to participate in the study
Time frame: through study period at 2 years
% of attrition
Time frame: through study period at 2 years
% of retention
Time frame: through study period at 2 years
% of participants who complete 80% of intervention sessions
Time frame: through year 1
time in minutes to train data collectors
Time frame: through year 1
time in minutes for data entry
Time frame: through study period at 2 years
participant strategies that helped them with participation in the study (interview)
Time frame: through the study period at 2 years
Enjoyment level for each participant (ordinal scale of 0=no enjoyment to 10=extreme enjoyment)
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)
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)
Time frame: through study period at 2 years
Frequency of communication with participants
Time frame: through study period at 2 years
Total time in minutes to communicate with participants
University of Alabama at Birmingham
Other
Feasibility of a Home-Based Vestibular Balance Therapy Intervention for Children With Vestibular Hypofunction
Acronym: VBT-C
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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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