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Vestibular DisorderNCT05793216

VestibulOTherapy: Vestibular Impact on Learning

A study testing VestibulOTherapy in people with Vestibular Disorder and Educational Problems, run by VestibulOTherapy at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Research Question: Will daily engagement in activities tailored to the evidence-based vestibular research result in improved attention and learning outcomes for children ages 6-9 years of age after an 8-week classroom-based intervention? Read more about this study

Who is it for?
Ages 6 to 10 years
What is being tested?
VestibulOTherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
7 Mar 2023to 25 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 6 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • neurotypical development
  • between the ages of 6-10 years of age
  • performance challenges in school in the areas of math, spelling, organization, sequencing, attention, or engagement
  • demonstrate attributes of vestibular dysfunction per the Vestibular Profile
  • may have ADD or ADHD
  • May have challenges with speech articulation
  • good potential for learning and engaging in prescribed interventions

Who cannot join

  • Neurodiverse development (with the exception of ADHD or ADD)
  • Absence of vestibular challenges
  • Absence of learning challenges.
  • unable to participate in interventions on a routine basis due to attendance or other limitations.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • School District of La Crosse

    La Crosse, Wisconsin, 54601

Other trials in United States

About this study

Research Question: Will daily engagement in activities tailored to the evidence-based vestibular research result in improved attention and learning outcomes for children ages 6-9 years of age after an 8-week classroom-based intervention?

Read the detailed description

"Vestibulotherapy" is an emerging frame of reference aiming to help neurotypical children with under-performing vestibular systems develop neural pathways supporting communication and learning.

Theory based upon systematic review: Given adequate vestibular activation through targeted activities (in an otherwise under-performing vestibular system), myelination and neuroplasticity propagate along learning pathways leading to greater neural connectivity and efficiency for sequencing, ordinance, attention, memory, body schema, spatial cognition, executive function, and interoception.

As a result of prescribed vestibular interventions and gained attributes supporting learning, students will experience increased academic growth and success as outlined by the following model.

Being tested
VestibulOTherapy
Keywords
vestibular, occupational therapy, children, educational outcomes
Medical subject headings
Vestibular Diseases, Attention Deficit Disorder with Hyperactivity

What participants receive

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

  • VestibulOTherapyBehavioural

    Also called occupational therapy

    For this study, the following activity-orientated interventions will occur within the natural learning environments so that generous opportunities exist for neural plasticity and growth.

    Each student will be engaged in 20-30 minutes/day of intermittent classroom activities, plus 20-30- minutes of daily stability work embedded into classroom routines including stabilizing self on a Hokki stool or t-stool or standing on a balance board during sedentary work, such as circle time or read-a-loud.

Study groups in NCT05793216
Study groupRoleWhat they receive
Classroom interventionsExperimentalStudents within five classrooms will engage in prescribed vestibular activities embedded within learning curricula to determine the impact of the intervention on learning outcomes, particularly memory, sequencing, attention, and ordinance related outcomes.
Receives: Behavioral: VestibulOTherapy

What is being measured

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

  1. Change in Academic Score reporting

    Academic record review: Math, spelling, and reading records from the 1st Semester of school will indicate trends in student performance. Immediately following and six months post-intervention, the trends will be compared to determine if a significant change occurs in these dependent variables. During and immediately following the intervention, spelling and math tests will be taken on consistent days of the week to avoid variabilities in data. Numerical data will be graphed to illustrate and examine trends and slope over time to determine significance of change.

    Measured: Baseline data established at recruitment, followed by weekly data collection of scores from spelling and math for twelve weeks, and again once at three-months post intervention

  2. Vestibular Attributes

    Vestibular Profile - Pediatric (VP-P) will be completed at recruitment. The most salient attributes will be monitored weekly throughout the intervention.

    Measured: up to twelve weeks

  3. Time on Task / Attention

    Time on Task measures reflecting active participation and attention during instruction

    Measured: up to twelve weeks

Timeline

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

  1. First posted31 Mar 2023
  2. Study start7 Mar 2023
  3. Primary completion5 May 2023 (estimated)
  4. Study completion25 Oct 2023 (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
Other
Allocation
Not applicable
Intervention model
Sequential
Model description
This program involves a multiple baseline design for a group of students ages 6-9 years. The intervention will last for 8 weeks with educational outcomes monitored before, during, and after the intervention. With final reporting at 6 months post intervention.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05793216
Sponsor's protocol ID
03072023
Status last verified
Mar 2023
First submitted
8 Mar 2023
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification will be shared through publications related to research outcomes.

Publications

  • Besnard S, Tighilet B, Chabbert C, Hitier M, Toulouse J, Le Gall A, Machado ML, Smith PF. The balance of sleep: Role of the vestibular sensory system. Sleep Med Rev. 2018 Dec;42:220-228. doi: 10.1016/j.smrv.2018.09.001. Epub 2018 Sep 8.

    PubMed 30293919

  • Hitier M, Besnard S, Smith PF. Vestibular pathways involved in cognition. Front Integr Neurosci. 2014 Jul 23;8:59. doi: 10.3389/fnint.2014.00059. eCollection 2014.

    PubMed 25100954

  • Emami Kashfi T, Sohrabi M, Saberi Kakhki A, Mashhadi A, Jabbari Nooghabi M. Effects of a Motor Intervention Program on Motor Skills and Executive Functions in Children With Learning Disabilities. Percept Mot Skills. 2019 Jun;126(3):477-498. doi: 10.1177/0031512519836811. Epub 2019 Mar 16.

    PubMed 30879395

  • Lopez C, Toupet M, van Nechel C, Bozorg Grayeli A. Editorial: Role of Inner Ear in Self and Environment Perception. Front Neurol. 2020 Feb 20;11:22. doi: 10.3389/fneur.2020.00022. eCollection 2020. No abstract available.

    PubMed 32153485

  • Lotfi Y, Rezazadeh N, Moossavi A, Haghgoo HA, Rostami R, Bakhshi E, Badfar F, Farokhi Moghadam S, Sadeghi-Firoozabadi V, Khodabandelou Y. Rotational and Collic Vestibular-Evoked Myogenic Potential Testing in Normal Developing Children and Children With Combined Attention Deficit/Hyperactivity Disorder. Ear Hear. 2017 Nov/Dec;38(6):e352-e358. doi: 10.1097/AUD.0000000000000451.

    PubMed 28562425

  • Mast FW, Preuss N, Hartmann M, Grabherr L. Spatial cognition, body representation and affective processes: the role of vestibular information beyond ocular reflexes and control of posture. Front Integr Neurosci. 2014 May 27;8:44. doi: 10.3389/fnint.2014.00044. eCollection 2014.

    PubMed 24904327

  • Matuszkiewicz M, Galkowski T. Developmental Language Disorder and Uninhibited Primitive Reflexes in Young Children. J Speech Lang Hear Res. 2021 Mar 17;64(3):935-948. doi: 10.1044/2020_JSLHR-19-00423. Epub 2021 Feb 23.

    PubMed 33621124

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing VestibulOTherapy in people with Vestibular Disorder and Educational Problems, run by VestibulOTherapy at 1 site in United States.

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. 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 United States. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Academic Score reporting (time frame: Baseline data established at recruitment, followed by weekly data collection of scores from spelling and math for twelve weeks, and again once at three-months post intervention). The study lists 3 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 NCT05793216, which also lists 8 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 31 Mar 2023.

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