Vestibular Infant Screening - Rehabilitation

Study Overview
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Brief Summary
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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. The main questions it aims to answer are: What are the short-term effects 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? Participant will engage in two active rehabilitation programs (VIS-REHAB and SHAM therapy protocol), followed by a 9-week period during which therapy will be discontinued (NO therapy 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. SHAM therapy protocol: General gross motor training without specific focus on gaze stability and postural control. Researchers will compare the VIS-REHAB protocol with standard care in flanders (SHAM therapy protocol) and with receiving no therapy (NO therapy protocol) to evaluate potential enhancements in postural stability, gaze stability, motor performance and quality of life.

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

Conditions
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Vestibular Disorder

Intervention / Treatment
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* Behavioral: VIS-REHAB protocol
* Behavioral: SHAM therapy protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Six-parallel group, superiority randomized controlled crossover trial with 1:1:1 allocation ratio. A randomized controlled trial will be used to determine and compare the effect of the VIS-REHAB protocol with the effect of the SHAM therapy protocol. Both active rehabilitation protocols will be compared with receiving no therapy (NO therapy protocol) (parallel design). Adding a cross-over design has the advantage that patients can serve as their own control and that all patients have access to the best possible care. It has the disadvantage that the long-term effect of the therapy programme cannot be evaluated as they succeed each other. However, due to ethical considerations, a cross-over design was considered the most appropriate.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIS-REHAB Protocol<br>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<br>* 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 emphasizes 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.<br>|
| Sham Comparator: SHAM Therapy Protocol<br>SHAM therapy entails 30-minute sessions conducted twice a week over a span of 9 weeks. Each session consists of three components of general gross motor training, encompassing core stability, agility, bilateral coordination, eye-foot or eye-hand coordination. | Behavioral: SHAM therapy protocol<br>* Exercises on general gross motor training targeting core stability, agility, bilateral coordination, eye-foot and eye-hand coordination. Only gross motor skills are trained, without specific attention to the principles of vestibular rehabilitation (adaptation, substitution), without specific exercises that are characteristic for vestibular rehabilitation (improving postural and gaze stability) and with counselling only on the background of the gross motor exercises, without any information or focus on the vestibular issue.<br>|
| No Intervention: NO Therapy Protocol<br>Cessation of all forms of physical therapy in the context of motor development (e.g. 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. | |

What is the study measuring?
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Primary 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. | 
| 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. | 
| 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. | 
| 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 |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapy, Vestibular Rehabilitation Therapy, VRT, Gaze stability, Postural control