Vestibular Infant Screening - Rehabilitation (VIS-REHAB)

Ghent University Hospital (UZ)

Status: Not yet enrolling

Conditions: Vestibular Disorder

Treatments: Behavioral: VIS-REHAB protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06177132

VIS-REHAB

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

VIS-REHAB Protocol

Experimental group

Description:

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.

Treatment:

Behavioral: VIS-REHAB protocol

CTRL Protocol

No Intervention group

Description:

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.