VestibulOTherapy: Vestibular Impact on Learning

NCT05793216 | Unknown

• 1 other identifier: 03072023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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?

Conditions

Vestibular Disorder; Educational Problems; Attention Deficit Disorder

Keywords

vestibular; occupational therapy; children; educational outcomes

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Time on Task / Attention

  Time on Task measures reflecting active participation and attention during instruction

  up to twelve weeks

Study Arms (1)

Classroom interventions

EXPERIMENTAL

Students 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.

Behavioral: VestibulOTherapy

Interventions

VestibulOTherapy BEHAVIORAL

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.

Also known as: occupational therapy

Classroom interventions

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VestibulOTherapy: lead
• University of Wisconsin, La Crosse: collaborator
• Boston University: collaborator

Study Sites (1)

School District of La Crosse

La Crosse, Wisconsin, 54601, United States

Location

Related 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.

  PMID: 30293919 BACKGROUND

• 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.

  PMID: 25100954 BACKGROUND

• 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.

  PMID: 30879395 BACKGROUND

• 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.

  PMID: 32153485 BACKGROUND

• 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.

  PMID: 28562425 BACKGROUND

• 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.

  PMID: 24904327 BACKGROUND

• 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.

  PMID: 33621124 BACKGROUND

• 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.

  PMID: 31466025 BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases; Attention Deficit Disorder with Hyperactivity

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Constance L Wall, OTD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome measures will be reviewed by a neutral party to avoid bias.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 31, 2023
• Study Start: March 7, 2023
• Primary Completion: May 5, 2023
• Study Completion: October 25, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)