WithdrawnNot Applicable

Building Long-term Academic Success Through Ongoing Fun Fitness Program

Stopped: The PI has left the institution

0Started 2019-10-01

Plain-language 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.

Who can participate

Age range

5 Years – 13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * students in grades kindergarten through fourth grade, * students below grade level in reading * in Odyssey Academy's reading program Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 10 weeks, 20 weeks

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

Timeframe: Baseline, 10 weeks, 20 weeks

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

Timeframe: 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)

Timeframe: Baseline, 10 weeks, 20 weeks

Trial details

NCT IDNCT04113707

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-26

View on ClinicalTrials.gov More Reading Disorder trials

Plain-language summary

Who can participate

Age range

5 Years – 13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline, 10 weeks, 20 weeks

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

Timeframe: Baseline, 10 weeks, 20 weeks

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

Timeframe: 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)

Timeframe: Baseline, 10 weeks, 20 weeks