Clinical trial NCT05793216: VestibulOTherapy: Vestibular Impact on Learning
Official title: VestibulOTherapy: Vestibular Impact on Learning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Disorder
Educational Problems
Attention Deficit Disorder
Keywords: vestibular
occupational therapy
children
educational outcomes
Lead sponsor: VestibulOTherapy
Sponsor class: INDUSTRY
Collaborators: name: University of Wisconsin, La Crosse
name: Boston University
First posted: 2023-03-31
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: OTHER

Brief 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?

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Academic Score reporting
timeFrame: 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
measure: Vestibular Attributes
timeFrame: up to twelve weeks
measure: Time on Task / Attention
timeFrame: up to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: School District of La Crosse
state: Wisconsin
Study officials:
affiliation: Boston University
name: Constance L Wall, OTD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.