Vestibular Infant Screening - Rehabilitation

NCT06177132 | Not Yet Recruiting

• 1 other identifier: VIS-REHAB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disorder

Keywords

Therapy; Vestibular Rehabilitation Therapy; VRT; Gaze stability; Postural control

Outcome Measures

Primary Outcomes (2)

• Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB)

  The child stands barefoot with feet together as still as possible for 30 seconds. There are eight test conditions: eyes open or closed, with or without foam, and eyes open or closed while on a foam, nodding the head in yaw or pitch at 0.33 Hz. The test will be conducted on a force platform, a Wii Balance Board (Nintendo Co., Ltd.), using the Colorado University BrainBLoX software. The total test time (s), anteroposterior and mediolateral sway (mm), centre of pressure path length (cm), sway velocity (m/s), and 95% confidence ellipse area (cm2 ) are measured by a custom-made code in MATLAB (The MathWorks, Inc. Natick, Massachusetts, United States).

  Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.

• Gaze stability as assessed by the Dynamic Visual Acuity (DVA) test

  The setup of the test is similar to that of the Static Visual Acuity (SVA) test, the only difference being that the patient's head will be passively moved by the examiner in the horizontal plane at a 2Hz-frequency over an amplitude of 15° from centre. The difference between the SVA and the DVA score will be included as output measure.

  Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.

Secondary Outcomes (8)

• Functional mobility and dynamic postural control during walking as assessed by the Timed Up and Go Test (TUG)

  At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

• Dynamic postural stability during walking as assessed by the Paediatric Modified Dynamic Gait Index (DGI)

  At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

• 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)

  At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

• Fine and gross motor skill assessment assessed by the Bruininks-Oseretsky Test of Motor Proficiency 2 (BOT-2)

  At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

• Quality of life as assessed by the Paediatric Quality of Life Inventory (PedsQL) 4.0

  At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

Study Arms (2)

VIS-REHAB Protocol

EXPERIMENTAL

The VIS-REHAB protocol entails 30-minute sessions conducted twice a week over a span of 9 weeks. These sessions are structured with 20 minutes dedicated to enhancing postural stability and 10 minutes focused on improving gaze stability. In greater detail, a minimum of 5 minutes time is reserved for counselling and providing background information on the exercises, focused on the vestibular issue. Apart from the counselling part, each session consist of 3 different exercise categories ((static postural stability, dynamic postural stability, general gross motor training (focus on PS), oculomotor function, gaze stability, or general gross motor training (focus on GS)), each carried out for 5 to 10 minutes.

Behavioral: VIS-REHAB protocol

CTRL Protocol

NO INTERVENTION

In the control (CTRL) protocol, all forms of physical therapy in the context of motor development are ceased. Occupational therapy, speech-language therapy and physical therapy for other purposes are not covered by this commitment. Additionally, the child and parents are asked to not do any home exercises on their own. However, sports activities and other recreational hobbies will not be asked to be temporary halted, since they will be continued in the active rehabilitation programme as well.

Interventions

VIS-REHAB protocol BEHAVIORAL

The VIS-REHAB protocol entails two essential components: postural stability (PS) and gaze stability (GS). Within the postural stability component of the VIS-REHAB protocol, there are static and dynamic balance exercises, along with general gross motor activities targeting core stability, agility, and bilateral coordination. The gaze stability part includes exercises enhancing oculomotor function such as smooth pursuit and saccadic movements, as well as VOR-exercises. Additionally, a general gross motor training program emphasises gaze stability by including exercises that improve eye-foot and eye-hand coordination. Furthermore, each session includes counselling and the provision of background information on the exercises.

VIS-REHAB Protocol

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

University Hospital Gent

Ghent, East Flanders, 9000, Belgium

Location

Related Publications (5)

• 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.

  PMID: 31466025 BACKGROUND

• 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.

  PMID: 32036319 BACKGROUND

• 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.

  PMID: 37514897 BACKGROUND

• 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.

  PMID: 30849604 BACKGROUND

• Fontaine M, Dhooge I, Dhondt C, Van Hecke R, Acke F, Van den Bossche L, Van Hoecke H, De Leenheer E, Maes L. Vestibular Infant Screening-Rehabilitation (VIS-REHAB): protocol for a randomised controlled trial on Vestibular Rehabilitation Therapy (VRT) in vestibular-impaired children. BMJ Open. 2024 Dec 20;14(12):e085575. doi: 10.1136/bmjopen-2024-085575.

  PMID: 39806605 DERIVED

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Leen Maes, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke L Fontaine, MSc

CONTACT

+32471125495; marieke.fontaine@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants cannot be blinded to their assigned groups, as they will be aware of the protocol received at any given time. The assessment of primary and secondary outcome measures will be conducted by a separate outcome assessor who will be blinded to patient allocation. Data analysis procedures will not involve blinding since they will be performed by the same individual responsible for conducting the rehabilitation sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-parallel group, superiority, randomised controlled crossover trial with 1:1 allocation ratio

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months and ending 36 months following the publication of study results.

Locations

BE (1)