VestibulOTherapy: Vestibular Impact on Learning

Sponsor

VestibulOTherapy (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05793216

Collaborator

University of Wisconsin, La Crosse (Other), Boston University (Other)

Enrollment

Location

Arm

7.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Vestibular Disorder Educational Problems Attention Deficit Disorder	Behavioral: VestibulOTherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

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.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)

Masking Description:

Outcome measures will be reviewed by a neutral party to avoid bias.

Primary Purpose:

Other

Official Title:

VestibulOTherapy: Vestibular Impact on Learning

Actual Study Start Date :

Mar 7, 2023

Anticipated Primary Completion Date :

May 5, 2023

Anticipated Study Completion Date :

Oct 25, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Academic Score reporting [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.
Vestibular Attributes [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.
Time on Task / Attention [up to twelve weeks]
Time on Task measures reflecting active participation and attention during instruction

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.