Vestibular Balance Therapy Intervention for Children

Vestibular Disorder Clinical Trial

— VBT-C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741515
• Other study ID #: IRB-300010569
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Michael A. Matthews
• Phone: 205-934-5266
• Email: osp[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Bilateral Vestibulopathy
• Nervous System Diseases
• Vestibular Diseases
• Vestibular Disorder

Intervention

Other:
• Vestibular Balance Therapy
see intervention arm description
• Sham Intervention
see sham intervention arm description

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Foundation for Physical Therapy Research

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

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