Vestibular Infant Screening - Rehabilitation (VIS-REHAB)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vestibular Disorder
• Intervention / Treatment: Behavioral: VIS-REHAB protocol

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marieke L Fontaine, MSc; Phone Number: +32471125495; Email: marieke.fontaine@ugent.be

Study Locations

• Belgium
  • East Flanders
    • Gent, East Flanders, Belgium, 9000
      • University Hospital Gent
      • Contact: Leen Maes; Phone Number: +32 9 332 40 66; Email: leen.maes@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static postural stability and sensory integration as assessed by the Bipedal Leg Standing Test	Children will be asked to stand with bare feet on foam as still as possible for 30 seconds, first with eyes open and then with eyes closed. The test will be conducted on a force platform, a Wii Balance Board (Nintendo Co., Ltd.), using the Colorado University BrainBLoX software. Anteroposterior and mediolateral sway (mm) of the body will be recorded 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static postural stability as assessed by the Single Leg Standing Test (SLS)	Subjects will be instructed to stand on one leg as long as possible. After explanation and demonstration of the procedure, children will be granted one attempt (for 10 seconds) to get familiar with the exercise. SLS will be carried out both with eyes open and with eyes closed and 3 trials will be conducted. Duration (s) will be the included response parameter for the SLS.	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	The Paediatric Functional Reach test is a measure for dynamic postural stability in both forward and lateral directions. After explanation and demonstration of the test, children will be instructed to reach as far forward and sideward as possible with their dominant hand and without moving the feet. Three trials will be conducted in each condition. The furthest reaching point subtracted by the reaching distance in neutral, symmetrical posture will be included for analysis (cm).	Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.
Functional mobility and dynamic postural control during walking as assessed by the Timed Up and Go Test (TUG)	The TUG test assesses functional mobility and dynamic postural stability during walking. Subjects, sitting 3m away from a wall, will be asked on the 'go' command to get up from the chair, walk towards the wall and touch it, come back to the chair and have a seat. Before the test, the procedure will be explained and demonstrated. Three trials will be conducted and the best time (recorded with stopwatch) will be used for analysis.	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 treadmill walking	Subjects will be asked to walk on an adaptive walking treadmill (Xiaomi WalkingPad C1®; Xiaomi Běijīng, China; 144.9 cm x 52.8 cm x 11.7 cm). In order to normalize the walking pattern first, each child will start with a familiarisation period with a maximum duration of five minutes. Then, the participant will be asked to walk at a self-selected pace for 5 minutes. Using the Xiaomi Walkingpad software and two cameras (D3300, Nikon, Tokyo, Japan - operating at 50 frames/second, and D500, Canon USA, Inc., Melville, New York, USA - operating at 30 frames/second), information on a variety of spatiotemporal parameters will be collected: stride and step length (cm), step width (cm), step and stride time (s), and walking velocity (cm/s).	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)	The children will be instructed to sit on a chair and fixate an attractive visual target (i.e. movie on a tablet) at 1.50 m distance. Meanwhile the examiner will perform unpredictable head movements (10° - 20° amplitude) in, respectively, the horizontal, LARP (to stimulate the left anterior and right posterior canal), and RALP plane (to stimulate the right anterior and left posterior canal). Prior to interpretation of the results, the data will be thoroughly cleaned according to the following criteria: (1) head velocity between 120°/s (vertical) or 150°/s (horizontal) and 250°/s (upper limit for vertical and horizontal), and (2) head bounce below 25 % of the peak head velocity. The measured gain (of the VOR) (%), the symmetry between the left and right side (%), and the presence of covert/overt saccades (n, and % of the performed HITs) will be taken as outcome measures of this test.	At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)
Movement assessment battery for children, 2nd edition (MABC-2)	The purpose of the MABC-2 is the identification and description of impairments in motor performance of children 3-17 years of age. Children have to complete a series of fine and gross motor tasks grouped in three categories: manual dexterity, aiming and catching, and balance. These eight different and age appropriate tasks will yield a total score of the MABC-2, subscale scores and item scores to determine the level of motor competence of the participant.	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	. It is a 23-item inventory, applicable for (parents of) children from 2 to 18 year. It consists of four subdomains: (i) physical functioning (eight items), (ii) emotional functioning (five items), (iii) social functioning (five items), and (iv) school functioning (five items). Items are scored through a 5-point rating scale.	At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent
• Investigators: Principal Investigator: Leen Maes, PhD, University Ghent

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Therapy; Postural control; Vestibular Rehabilitation Therapy; VRT; Gaze stability
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: VIS-REHAB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No