VestibulOTherapy: Vestibular Impact on Learning

Educational Problems Clinical Trial

Official title:

VestibulOTherapy: Vestibular Impact on Learning

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05793216
• Other study ID #: 03072023
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: October 25, 2023

Study information

• Verified date: March 2023
• Source: VestibulOTherapy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: October 25, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Disease
• Educational Problems
• Vestibular Diseases
• Vestibular Disorder

Intervention

Behavioral:
• VestibulOTherapy
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.

Locations

Country	Name	City	State
United States	School District of La Crosse	La Crosse	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
VestibulOTherapy	Boston University, University of Wisconsin, La Crosse

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	Vestibular Attributes	Vestibular Profile - Pediatric (VP-P) will be completed at recruitment. The most salient attributes will be monitored weekly throughout the intervention.	up to twelve weeks
Primary	Time on Task / Attention	Time on Task measures reflecting active participation and attention during instruction	up to twelve weeks