Vestibular Infant Screening - Rehabilitation

NCT ID: NCT06177132

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VIS-REHAB Protocol

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.

Group Type: EXPERIMENTAL

VIS-REHAB protocol

Intervention Type: 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.

CTRL Protocol

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VIS-REHAB protocol

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leen Maes, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

University Hospital Gent

Ghent, East Flanders, Belgium

Countries

Belgium

Central Contacts

Marieke L Fontaine, MSc

Role: CONTACT

marieke.fontaine@ugent.be

+32471125495

Facility Contacts

Leen Maes

Role: primary

leen.maes@ugent.be

+32 9 332 40 66

References

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.

Reference Type: BACKGROUND

PMID: 31466025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32036319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37514897 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30849604 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39806605 (View on PubMed)

Other Identifiers

VIS-REHAB

Identifier Type: -

Identifier Source: org_study_id