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VestibulOTherapy: Vestibular Impact on Learning

Primary Purpose

Vestibular Disorder, Educational Problems, Attention Deficit Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VestibulOTherapy
Sponsored by
VestibulOTherapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vestibular Disorder focused on measuring vestibular, occupational therapy, children, educational outcomes

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • School District of La Crosse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Classroom interventions

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Vestibular Attributes
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
Time on Task measures reflecting active participation and attention during instruction

Secondary Outcome Measures

Full Information

First Posted
March 8, 2023
Last Updated
March 30, 2023
Sponsor
VestibulOTherapy
Collaborators
University of Wisconsin, La Crosse, Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT05793216
Brief Title
VestibulOTherapy: Vestibular Impact on Learning
Official Title
VestibulOTherapy: Vestibular Impact on Learning
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
May 5, 2023 (Anticipated)
Study Completion Date
October 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VestibulOTherapy
Collaborators
University of Wisconsin, La Crosse, Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder, Educational Problems, Attention Deficit Disorder
Keywords
vestibular, occupational therapy, children, educational outcomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Masking Description
Outcome measures will be reviewed by a neutral party to avoid bias.
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classroom interventions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
VestibulOTherapy
Other Intervention Name(s)
occupational therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Academic Score reporting
Description
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.
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
Title
Vestibular Attributes
Description
Vestibular Profile - Pediatric (VP-P) will be completed at recruitment. The most salient attributes will be monitored weekly throughout the intervention.
Time Frame
up to twelve weeks
Title
Time on Task / Attention
Description
Time on Task measures reflecting active participation and attention during instruction
Time Frame
up to twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance L Wall, OTD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School District of La Crosse
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30293919
Citation
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.
Results Reference
background
PubMed Identifier
25100954
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.
Results Reference
background
PubMed Identifier
30879395
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.
Results Reference
background
PubMed Identifier
32153485
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.
Results Reference
background
PubMed Identifier
28562425
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.
Results Reference
background
PubMed Identifier
24904327
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.
Results Reference
background
PubMed Identifier
33621124
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.
Results Reference
background
PubMed Identifier
31466025
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.
Results Reference
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VestibulOTherapy: Vestibular Impact on Learning

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