VestibulOTherapy: Vestibular Impact on Learning

March 30, 2023 updated by: VestibulOTherapy
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?

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • School District of La Crosse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Classroom interventions
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

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.

Other Names:
  • occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: up to twelve weeks
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 Frame: up to twelve weeks
Time on Task measures reflecting active participation and attention during instruction
up to twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VestibulOTherapy

Collaborators

Boston University
University of Wisconsin, La Crosse

Investigators

  • Principal Investigator: Constance L Wall, OTD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2023

Primary Completion (Anticipated)

May 5, 2023

Study Completion (Anticipated)

October 25, 2023

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03072023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be shared through publications related to research outcomes.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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