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Vestibular Infant Screening-Rehabilitation (VIS-REHAB): protocol for a randomised controlled trial on Vestibular
Marieke Fontaine1,2, Ingeborg Dhooge2,3, Cleo Dhondt2
1Faculty of Medicine and Health Sciences, Department of Rehabilitation Sciences, Ghent University, Gent, Belgium marieke.fontaine@ugent.be.
Insights
This study evaluates the Vestibular Infant Screening-Rehabilitation (VIS-REHAB) protocol for children with vestibular deficits. It assesses the protocol
Area of Science:
- Pediatric Vestibular Rehabilitation
- Childhood Neurodevelopmental Disorders
- Clinical Trial Design and Analysis
Background:
- Vestibular deficits significantly impact child development, necessitating early and effective interventions.
- Vestibular Rehabilitation Therapy (VRT) is established in adults but lacks robust evidence in pediatric populations.
- The Vestibular Infant Screening-Rehabilitation (VIS-REHAB) protocol was developed to address this research gap.
Purpose of the Study:
- To evaluate the short-term efficacy of the VIS-REHAB protocol (combined postural control and gaze stabilization) in children with vestibular impairment.
- To identify factors influencing the effectiveness and outcomes of the VIS-REHAB protocol.
- To establish evidence-based rehabilitation guidelines for pediatric vestibular dysfunction.
Main Methods:
- A two-parallel group, superiority, randomized controlled crossover trial (VIS-REHAB study) with 1:1 allocation.
- Inclusion of patients aged 3-17 years with diagnosed peripheral vestibular dysfunction.
- Assessment of primary and secondary outcomes including gaze stability, postural stability, motor performance, and quality of life, analyzed using ANCOVA with subgroup analyses.
Main Results:
- The study is designed to compare the VIS-REHAB protocol against a no-therapy control group.
- Effectiveness will be evaluated through parallel group and crossover analyses.
- Subgroup analyses will explore factors influencing treatment outcomes.
Conclusions:
- The VIS-REHAB study aims to provide crucial evidence on the effectiveness of a standardized VRT protocol for children.
- Findings will contribute to developing evidence-based guidelines for pediatric vestibular rehabilitation.
- This research addresses a critical need for effective interventions in children with vestibular impairments.
Introduction:
A vestibular deficit can have a substantial impact on the overall development of children. Therefore, it is of utmost importance that vestibular-impaired problems are treated early and effectively through Vestibular Rehabilitation Therapy (VRT). Although VRT is sufficiently proven and standardised in adults, there remains a lack of research examining its efficacy in children. To assess the effectiveness of VRT in vestibular-impaired children, the Vestibular Infant Screening-Rehabilitation (VIS-REHAB) protocol was developed with the following objectives: (1) to investigate the short-term effect of a combined postural control and gaze stabilisation protocol, compared with receiving no therapy and (2) to investigate the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol in a group of vestibular-impaired children. This study aims to address lingering questions in the existing literature in a standardised manner, with the ultimate objective to establish evidence-based rehabilitation guidelines.
Methods And Analysis:
The VIS-REHAB study is a two-parallel group, superiority, randomised controlled crossover trial with 1:1 allocation ratio. The study includes patients aged 3-17 years old with identified peripheral vestibular dysfunction. Primary and secondary outcome measures assess gaze stability, postural stability, motor performance and quality of life. The effectiveness of the VIS-REHAB protocol will be evaluated through parallel group and crossover analyses using analysis of covariance (ANCOVA). Additionally, prespecified subgroup analyses will be conducted to assess influencing factors that may impact the outcome and effect of VIS-REHAB.
Ethics And Dissemination:
At the start of the VIS-REHAB study, an amendment will be submitted to the ethics committee of Ghent University Hospital for the following applications: (EC2018/0435), (EC2018/0959), (EC2015/1441) and (EC2015/1442). The trial is registered at Clinical Trials (clinicaltrials.gov) with registry name VIS-REHAB and identifier NCT06177132. All research findings will be disseminated in peer-reviewed journals.
Trial Registration Number:
NCT06177132.
