NCT04113707

Brief Summary

The purpose of the research study is to investigate if daily motor activities, including fitness activities, gross motor skills, fine motor skills, and motor coordination activities result in physiological, cognitive, and behavioral benefits to children at Odyssey Academy. The study will compare students' performance after intervention by comparing an intervention period to a standard care period, and comparing intervention students to students engaged in standard school activities in the area of academic performance.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2024

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

September 30, 2019

Last Update Submit

July 18, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in Movement Assessment Battery for Children-2 (MABC-2) between 3 time points (baseline, 10 weeks, 20 weeks)

    Motor skills test which provides standard scores from 1-19 where higher scores represent better performance.

    Baseline, 10 weeks, 20 weeks

  • Change in Wechsler Intelligence Scale for Children-5 (WISC-5) between 3 time points (baseline, 10 weeks, 20 weeks)

    Measures of executive function which provides scale scores from 1-19 where higher scores represent better performance.

    Baseline, 10 weeks, 20 weeks

  • Change in Test of Visual Motor Integration (VMI) between 3 time points (baseline, 10 weeks, 20 weeks)

    Measures of visual perception and visual motor skills providing scores from 45-155 where higher scores represent better performance.

    Baseline, 10 weeks, 20 weeks

  • Change in Behavior Rating Inventory of Executive Function - Parent and Teacher Forms between 3 time points (baseline, 10 weeks, 20 weeks)

    Measure of behavioral executive function with score within the range of 30-90 where scores \>60 represent poorer performance.

    Baseline, 10 weeks, 20 weeks

Secondary Outcomes (2)

  • Change in Renaissance Star Reading Assessment between 3 time points (baseline, 10 weeks, 20 weeks)

    Baseline, 10 weeks, 20 weeks

  • Change in Fitness Gram between 3 time points (baseline, 10 weeks, 20 weeks)

    Baseline, 10 weeks, 20 weeks

Study Arms (2)

Motor Lab

EXPERIMENTAL

Group A will receive 20 minutes of motor lab intervention daily.

Behavioral: Motor lab activity

Standard of Care

NO INTERVENTION

Group B will receive standard of care which will be 20 minutes of reading per day.

Interventions

fitness, gross motor, fine motor, and motor coordination activities

Motor Lab

Eligibility Criteria

Age5 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • students in grades kindergarten through fourth grade,
  • students below grade level in reading
  • in Odyssey Academy's reading program

You may not qualify if:

  • students that are not part of the specialized reading program at Odyssey Academy
  • are unwilling to participate in the motor lab intervention
  • lack conversational ability in the use of the English language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pre and post two group intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 3, 2019

Study Start

October 1, 2019

Primary Completion

September 26, 2024

Study Completion

September 26, 2024

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share