Reading DisorderBLASTOFFNCT04113707
Building Long-term Academic Success Through Ongoing Fun Fitness Program
A study testing Motor lab activity in people with Reading Disorder, run by The University of Texas Medical Branch, Galveston.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Reading Disorder
- What is being tested?
- Motor lab activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 26 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students in grades kindergarten through fourth grade,
- students below grade level in reading
- in Odyssey Academy's reading program
Who cannot join
- 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.
About this study
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.
Read the detailed description
The objective of this study is to track if daily participation in motor lab activities for school age children improves their academic performance. Academic performance is associated with motor skills, coordination, and executive function. Our objectives are to determine if daily participation in motor lab activities changes these skills, to better understand these relationships, track outcomes of children participating in motor lab intervention compared to non-intervention and children receiving standard level of care in the school, and to be able to follow the intervention students over time.
The specific aims of the study are:
- To investigate whether gross motor skills, fine motor skills, and physical fitness, predict executive function skills.
- To determine the relationship between these variables and academic performance.
- To examine the relationship between participation in motor lab activities and measures of change in fitness, gross motor skills, fine motor skills, executive function, and academic performance.
- To evaluate if participation in daily motor lab activities predicts fitness level, gross motor skills, fine motor skills, executive function, and academic success at the end of the school year and in the next school year.
- Conditions
- Reading Disorder
- Being tested
- Motor lab activity
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor lab activityBehavioural
fitness, gross motor, fine motor, and motor coordination activities
| Study group | Role | What they receive |
|---|---|---|
| Motor Lab | Experimental | Group A will receive 20 minutes of motor lab intervention daily. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 10 weeks, 20 weeks
Secondary outcomes (2)
Change in Renaissance Star Reading Assessment between 3 time points (baseline, 10 weeks, 20 weeks)
Reading assessment with domain scores ranging from 0-99 where higher scores represent stronger performance.
Measured: Baseline, 10 weeks, 20 weeks
Change in Fitness Gram between 3 time points (baseline, 10 weeks, 20 weeks)
fitness assessment with scores falling within either healthy fitness zone, needs improvement zone, or health risk zone.
Measured: Baseline, 10 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Oct 2019
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Why it stopped: The PI has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pre and post two group intervention
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113707
- Sponsor's protocol ID
- 19-0180
- Acronym
- BLASTOFF
- Status last verified
- Jul 2025
- First submitted
- 30 Sep 2019
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Long-term Academic Success Through Ongoing Fun Fitness Program
- ClinicalTrials.gov ID
- NCT04113707
- Acronym / sponsor ID
- BLASTOFF / 19-0180
- Conditions
- Reading Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI has left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is to track if daily participation in motor lab activities for school age children improves their academic performance. Academic performance is associated with motor skills, coordination, and executive function. Our objectives are to determine if daily participation in motor lab activities changes these skills, to better understand these relationships, track outcomes of children participating in motor lab intervention compared to non-intervention and children receiving standard level of care in the school, and to be able to follow the intervention students over time.
The specific aims of the study are:
- To investigate whether gross motor skills, fine motor skills, and physical fitness, predict executive function skills.
- To determine the relationship between these variables and academic performance.
- To examine the relationship between participation in motor lab activities and measures of change in fitness, gross motor skills, fine motor skills, executive function, and academic performance.
- To evaluate if participation in daily motor lab activities predicts fitness level, gross motor skills, fine motor skills, executive function, and academic success at the end of the school year and in the next school year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre and post two group intervention
| Arm | Type | Receives |
|---|---|---|
| Motor Lab | Experimental | Behavioral: Motor lab activityGroup A will receive 20 minutes of motor lab intervention daily. |
| Standard of Care | No intervention | –Group B will receive standard of care which will be 20 minutes of reading per day. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- students in grades kindergarten through fourth grade,
- students below grade level in reading
- in Odyssey Academy's reading program
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor lab activityfitness, gross motor, fine motor, and motor coordination activities | Behavioural | Motor Lab |
Primary outcome
Change in Movement Assessment Battery for Children-2 (MABC-2) between 3 time points (baseline, 10 weeks, 20 weeks)
Time frame: Baseline, 10 weeks, 20 weeks
Motor skills test which provides standard scores from 1-19 where higher scores represent better performance.
Change in Wechsler Intelligence Scale for Children-5 (WISC-5) between 3 time points (baseline, 10 weeks, 20 weeks)
Time frame: Baseline, 10 weeks, 20 weeks
Measures of executive function which provides scale scores from 1-19 where higher scores represent better performance.
Change in Test of Visual Motor Integration (VMI) between 3 time points (baseline, 10 weeks, 20 weeks)
Time frame: Baseline, 10 weeks, 20 weeks
Measures of visual perception and visual motor skills providing scores from 45-155 where higher scores represent better performance.
Change in Behavior Rating Inventory of Executive Function - Parent and Teacher Forms between 3 time points (baseline, 10 weeks, 20 weeks)
Time frame: Baseline, 10 weeks, 20 weeks
Measure of behavioral executive function with score within the range of 30-90 where scores >60 represent poorer performance.
2 secondary outcomes
Change in Renaissance Star Reading Assessment between 3 time points (baseline, 10 weeks, 20 weeks)
Time frame: Baseline, 10 weeks, 20 weeks
Change in Fitness Gram between 3 time points (baseline, 10 weeks, 20 weeks)
Time frame: Baseline, 10 weeks, 20 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motor lab activity in people with Reading Disorder, run by The University of Texas Medical Branch, Galveston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Movement Assessment Battery for Children-2 (MABC-2) between 3 time points (baseline, 10 weeks, 20 weeks) (time frame: Baseline, 10 weeks, 20 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.