Vestibular Infant Screening - Rehabilitation

Официальное название

Vestibular Infant Screening - Rehabilitation (VIS-REHAB): Protocol for a Randomised Controlled Trial on Vestibular Rehabilitation Therapy (VRT) in Vestibular-impaired Children

Обзор

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.

Вмешательства

• Поведенческое 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 gros

Первичные конечные точки

• Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB) [Срок оценки: 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 [Срок оценки: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.]

Вторичные конечные точки (8)

• Functional mobility and dynamic postural control during walking as assessed by the Timed Up and Go Test (TUG) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)]
• Static postural stability as assessed by the Single Leg Standing Test (SLS) [Срок оценки: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.]
• Dynamic postural stability as assessed by the Paediatric Functional Reach Test [Срок оценки: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.]
• Functional evaluation of the VOR by the Functional Head Impulse Test (fHIT) [Срок оценки: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• University Hospital Gent — Ghent

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06177132 · VIS-REHAB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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