Clinical trial NCT06177132: Vestibular Infant Screening - Rehabilitation
Official title: Vestibular Infant Screening - Rehabilitation (VIS-REHAB): Protocol for a Randomised Controlled Trial on Vestibular Rehabilitation Therapy (VRT) in Vestibular-impaired Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Keywords: Therapy
Vestibular Rehabilitation Therapy
VRT
Gaze stability
Postural control
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2023-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-parallel group, superiority, randomised controlled crossover trial with 1:1 allocation ratio
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the short-term effect of a structured, combined postural control and gaze stabilisation protocol (VIS-REHAB protocol) in a group of vestibular-impaired children of different age categories (3-17 years). The main questions it aims to answer are:

* What is the short-term effect of the VIS-REHAB protocol?
* What are the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol?

The participant will undergo both an active rehabilitation program (VIS-REHAB protocol) and a period during which physical therapy is discontinued (CTRL protocol).:

- VIS-REHAB protocol: Postural control (static and dynamic postural stability exercises), gaze stability exercises (oculomotor function and VOR-exercises) \& general gross motor training with focus on gaze stability and postural control.

Researchers will compare the VIS-REHAB protocol with receiving no therapy (CTRL protocol) to evaluate potential enhancements in postural stability, gaze stability, motor performance and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients with identified vestibular dysfunction
* With or without concomitant hearing loss and/or cochlear implant (CI)

Exclusion Criteria:

* Children incapable to understand simple instructions (due to severe cognitive disorders, impaired language comprehension, etc.)
* Severe disorders of other primary sensory input systems for balance function
* Severe neuromotor disorders (incapable of independent standing and walking)
* Severe muscle tone disorders (e.g. cerebral palsy)
* Severe orthopaedic dysfunctions
* Patients with vision problems that cannot be corrected for
* Children with planned CI-surgery within 5 months before or during the study period

Primary outcomes:
measure: Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB)
timeFrame: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
measure: Gaze stability as assessed by the Dynamic Visual Acuity (DVA) test
timeFrame: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
Secondary outcomes:
measure: Functional mobility and dynamic postural control during walking as assessed by the Timed Up and Go Test (TUG)
timeFrame: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)
measure: Dynamic postural stability during walking as assessed by the Paediatric Modified Dynamic Gait Index (DGI)
timeFrame: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)
measure: Superior and inferior vestibular nerve and the functioning of the six semicircular canals, using the vestibulo-ocular reflex (VOR) assessed by the video Head Impulse Test (vHIT)
timeFrame: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)
measure: Fine and gross motor skill assessment assessed by the Bruininks-Oseretsky Test of Motor Proficiency 2 (BOT-2)
timeFrame: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)
measure: Quality of life as assessed by the Paediatric Quality of Life Inventory (PedsQL) 4.0
timeFrame: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)
measure: Static postural stability as assessed by the Single Leg Standing Test (SLS)
timeFrame: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
measure: Dynamic postural stability as assessed by the Paediatric Functional Reach Test
timeFrame: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
measure: Functional evaluation of the VOR by the Functional Head Impulse Test (fHIT)
timeFrame: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Gent
state: East Flanders
Study officials:
affiliation: University Ghent
name: Leen Maes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melo RS, Lemos A, Paiva GS, Ithamar L, Lima MC, Eickmann SH, Ferraz KM, Belian RB. Vestibular rehabilitation exercises programs to improve the postural control, balance and gait of children with sensorineural hearing loss: A systematic review. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109650. doi: 10.1016/j.ijporl.2019.109650. Epub 2019 Aug 21.
citation: Melo RS, Tavares-Netto AR, Delgado A, Wiesiolek CC, Ferraz KM, Belian RB. Does the practice of sports or recreational activities improve the balance and gait of children and adolescents with sensorineural hearing loss? A systematic review. Gait Posture. 2020 Mar;77:144-155. doi: 10.1016/j.gaitpost.2020.02.001. Epub 2020 Feb 3.
citation: Melo RS, Lemos A, Delgado A, Raposo MCF, Ferraz KM, Belian RB. Use of Virtual Reality-Based Games to Improve Balance and Gait of Children and Adolescents with Sensorineural Hearing Loss: A Systematic Review and Meta-Analysis. Sensors (Basel). 2023 Jul 22;23(14):6601. doi: 10.3390/s23146601.
citation: Martens S, Dhooge I, Dhondt C, Leyssens L, Sucaet M, Vanaudenaerde S, Rombaut L, Maes L. Vestibular Infant Screening - Flanders: The implementation of a standard vestibular screening protocol for hearing-impaired children in Flanders. Int J Pediatr Otorhinolaryngol. 2019 May;120:196-201. doi: 10.1016/j.ijporl.2019.02.033. Epub 2019 Feb 25.