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Vestibular DisorderVIS-REHABNCT06177132

Vestibular Infant Screening - Rehabilitation

A study testing VIS-REHAB protocol in people with Vestibular Disorder, run by University Hospital, Ghent at 1 site in Belgium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 17 years
Conditions the study is for
Vestibular Disorder
What is being tested?
VIS-REHAB protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
Nov 2025to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marieke L Fontaine, MSc contact

+32471125495

marieke.fontaine@ugent.be

Belgium1 site

  • University Hospital Gent

    Ghent, East Flanders, 9000

    Leen Maes, +32 9 332 40 66, leen.maes@ugent.be

Other trials in Belgium

About this study

Official title: 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?
Read more

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.

Being tested
VIS-REHAB protocol
Keywords
Therapy, Vestibular Rehabilitation Therapy, VRT, Gaze stability, Postural control
Medical subject headings
Vestibular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIS-REHAB protocolBehavioural

    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.

Study groups in NCT06177132
Study groupRoleWhat they receive
VIS-REHAB ProtocolExperimentalThe 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.
Receives: Behavioral: VIS-REHAB protocol
CTRL ProtocolNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB)

    The child stands barefoot with feet together as still as possible for 30 seconds. There are eight test conditions: eyes open or closed, with or without foam, and eyes open or closed while on a foam, nodding the head in yaw or pitch at 0.33 Hz. The test will be conducted on a force platform, a Wii Balance Board (Nintendo Co., Ltd.), using the Colorado University BrainBLoX software. The total test time (s), anteroposterior and mediolateral sway (mm), centre of pressure path length (cm), sway velocity (m/s), and 95% confidence ellipse area (cm2 ) are measured by a custom-made code in MATLAB (The MathWorks, Inc. Natick, Massachusetts, United States).

    Measured: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.

  2. 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.

    Measured: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.

Secondary outcomes (8)

  1. Functional mobility and dynamic postural control during walking as assessed by the Timed Up and Go Test (TUG)

    Subjects sitting 3 m away from a 1m x 1m square with a cone in the centre, will be asked on the 'go' command to get up from the chair, walk to the square, navigate around the cone, 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. Outcome parameters include the total test duration (s), number of steps, walking speed (m/s) and mean step length (cm).

    Measured: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

  2. Dynamic postural stability during walking as assessed by the Paediatric Modified Dynamic Gait Index (DGI)

    Subjects will be asked to complete 8 tasks, including walking on a flat surface, adjusting speed, and walking with horizontal and vertical head movements. It also evaluated walking over and around obstacles, turning while walking, and stepping on stairs. Each task is scored on a 3-point scale, with 3 indicating normal performance and 0 indicating severe impairment. The total score will serve as the outcome parameter.

    Measured: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

  3. 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.

    Measured: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

  4. Fine and gross motor skill assessment assessed by the Bruininks-Oseretsky Test of Motor Proficiency 2 (BOT-2)

    Each subtest yields an independent score, covering areas such as fine motor precision, fine motor integration, manual dexterity, upper-limb coordination, bilateral coordination, balance, running speed and agility, and strength. These individual scores contribute to composite scores for fine manual skills, manual coordination, body coordination, strength and agility, fine motor skills, gross motor skills, and overall motor performance, offering a comprehensive assessment of motor abilities.

    Measured: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

  5. 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.

    Measured: At the start of each 9-week protocol and at the very end of the complete trajectory (9-week protocol + 1-week rest period)

  6. 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 three trials will be conducted. The test will be conducted on a force platform, a Wii Balance Board (Nintendo Co., Ltd.), using the Colorado University BrainBloX software. The total test time (s), anteroposterior and mediolateral sway (mm), centre of pressure path length (cm), sway velocity (m/s) and 95% confidence ellipse area (cm2).

    Measured: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.

  7. Dynamic postural stability as assessed by the Paediatric Functional Reach Test

    After explanation and demonstration of the test, children will be granted one attempt to get familiar with the exercise. Children will be instructed to reach as far forward and sideward as possible with their hand(s) 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).

    Measured: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.

  8. Functional evaluation of the VOR by the Functional Head Impulse Test (fHIT)

    fHIT measurements will be conducted using the DVAstar Head Sensor (DIFRA Instrumentation, Eupen, Belgium) and accompanying software 'DiSoft II'. Participants will be seated 3 meters away from a visual target, and those who wear glasses or contact lenses will be encouraged to use them during the examination. The child must identify the orientation of the optotype (the letter 'C') that briefly appears on a computer screen for 80 milliseconds during unpredictable passive 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). In each trial, the optotype is randomly rotated by 0°, 90°, 180°, or 270°. The size of the optotype corresponds to the SVA plus 0.6 LogMAR. The outcome parameter includes the percentage of correctly identified optotypes.

    Measured: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study startNov 2025 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-parallel group, superiority, randomised controlled crossover trial with 1:1 allocation ratio
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06177132
Sponsor's protocol ID
VIS-REHAB
Acronym
VIS-REHAB
Status last verified
Sep 2024
First submitted
11 Dec 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that will underlie the results reported in future publications of this study (text, tables, figures, and appendices) will be made available. The data will be available beginning 12 months and ending 36 months following the publication of the study results. Researchers who provide a methodologically sound proposal will be granted access. Proposals should be directed to marieke.fontaine@ugent.be. To gain access, data requestors will need to sign a data access agreement. The following documents will be available: study protocol, statistical analysis plan and informed consent forms. For further information or to submit a data access proposal, please contact marieke.fontaine@ugent.be.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 39806605

Questions about this trial

What is this clinical trial studying?

A study testing VIS-REHAB protocol in people with Vestibular Disorder, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marieke L Fontaine, MSc (+32471125495, marieke.fontaine@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static postural stability and sensory integration as assessed by the Modified Clinical Test of Sensory Integration on Balance (mCTSIB) (time frame: Baseline and repeated before and after completing each 9-week protocol. There is a 1-week rest period between consecutive protocols.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06177132, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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