Clinical trial NCT03903614: Sensory Motor Lateralization as Handwriting Intervention in School-Based OT
Official title: Handwriting Intervention, With vs. Without a Rightward Bias, in a Junior High School-A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Dysgraphia
Keywords: Developmental Dysgraphia
Ambidexterity
Outcome study
Lead sponsor: Teng, Mary H.
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Children who attend School-Based Occupational Therapy (SBOT) show mixed dominance and a liable decreased in the structural and functional differentiation between the two hemispheres. The lack of right-left disparity has been found to link to mirror invariance, poor spatial organization, fragmentary reversals, and handwriting difficulty. This study intends to find out, whether, Sensory Motor Lateralization (SML), "With" a rightward bias, profits handwriting more than the conventional (CON) "Without".

Detailed description: 10 to 30% of school children suffer handwriting difficulty. Many of them are eventually referred to SBOT for remedial intervention. Among these children, 70% show mixed dominance in their hand and/or leg use, and a likely functional and structural interhemispherical asymmetry reduction. This would make them right-left symmetrical. Learning, thus, may be challenged, because people who are right-left balanced would not have a consistent reference point to process the learning materials regularly in any pre-determined directions. They are, thus, prone to suffer mirror invariance, fragmentary reversal errors, and handwriting difficulty, especially with the fast and accurate construction of asymmetrical letters from memory.

To enhance right-left disparity, dispel mirror invariance, and facilitate the automatized handwriting, SML preferentially belabors one's right eye, ear, hand and leg in therapy, that would greater engage the left hemisphere for its acclaimed vantages over learning. This study investigates, whether SML, wielding such a rightward bias, profits handwriting greater than CON.

Eligibility criteria: Inclusion Criteria:

* Any Special or Regular Education students with Individualized Education Plans (IEPs), OT mandates, and handwriting goals.
* Has Intelligence Quotient (IQ) equal to or above 60.
* Ambulatory.
* Proficient in English, and fluent in naming, identifying, and accessing the sequence of letters in the alphabet.
* The students who attend Physical Therapy (PT), Adaptive Physical Education (PE), and any other programs are included, if the programs being provided are skill-, theme-, or task-oriented, not involving any muscle strengthening activities.

Exclusion Criteria:

* All are excluded, if the study candidates have any medical condition(s) that would prohibit them from the full physical participation in school.

Primary outcomes:
measure: SML excels CON in manuscript letter legibility
timeFrame: Change from Baseline percent accuracy score at 3 months
measure: SML excels CON in script letter legibility
timeFrame: Change from Baseline percent accuracy score at 3 months
measure: SML excels CON in manuscript transcription speed
timeFrame: Change from Baseline letters per minute at 3 months
measure: SML excels CON in script transcription speed
timeFrame: Change from Baseline letters per minute at 3 months
Secondary outcomes:
Other outcomes:
measure: SML excels CON in Visual Motor Integration
timeFrame: Change from Baseline raw score at 3 months
measure: SML excels CON in Visual Perception
timeFrame: Change from Baseline raw score at 3 months
measure: SML excels CON in Motor Coordination
timeFrame: Change from Baseline raw score at 3 months
Locations:
Study officials:
name: Mary H Teng, MS, OTR
role: PRINCIPAL_INVESTIGATOR
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