Sensory Motor Lateralization as Handwriting Intervention in School-Based OT (SML)

April 6, 2019 updated by: Mary H. Teng

Handwriting Intervention, With vs. Without a Rightward Bias, in a Junior High School-A Randomized Controlled Study

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensory Motor Lateralization (SML)
This was a group of 8 junior high school students who received SML in school for handwriting difficulty during the 2012-13 School Year. The participants received left eye-and-ear occlusion, fitness exercises, fine motor speed training, and handwriting practice on their right hand only.
Behavioral: SML
SML consists of supervised handwriting practice, fitness exercises, and fine motor speed drills that preferentially belabor a participant's right eye, ear, hand and leg during therapy.
Other Names:
  • Cerebral Lateralization Intervention
Active Comparator: Conventional School-Based OT (CON)
This was a group of 8 junior high school students who received conventional school-based Occupational Therapy service for handwriting difficulty during the 2012-13 School Year. The participants received a like fitness exercises, fine motor speed training, and handwriting practice on their dominant hand instead.
Behavioral: CON
CON consists of supervised handwriting practice, fitness exercises, and fine motor speed drills on the participant's dominant hand.
Other Names:
  • Conventional School-Based OT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SML excels CON in manuscript letter legibility
Time Frame: Change from Baseline percent accuracy score at 3 months
Assess by the percent accuracy score of manuscript letter legibility derived from the Wold Sentence Copying Test (WSCT). TThe letter legibility score was calculated by counting the total number of letters the participant wrote minus the writing errors per THS-R criteria, divided by the total number of characters written, and multiplied by 100. The minimum is 0, and the maximum is 100. The higher values represent better treatment outcome.
Change from Baseline percent accuracy score at 3 months
SML excels CON in script letter legibility
Time Frame: Change from Baseline percent accuracy score at 3 months
Assess by the percent accuracy score of script letter legibility derived from the Wold Sentence Copying Test (WSCT). The letter legibility score was calculated by counting the total number of letters the participant wrote minus the writing errors per THS-R criteria, divided by the total number of characters written, and multiplied by 100. The minimum is 0, and the maximum is 100. The higher values represent better treatment outcome.
Change from Baseline percent accuracy score at 3 months
SML excels CON in manuscript transcription speed
Time Frame: Change from Baseline letters per minute at 3 months
Assess by WSCT.Speed was derived from the total number of letters written timed 60, divided by the total number of seconds used, and recorded as number of letters per minute. The minimum is 0, and there is no maximum. The higher values represent better treatment outcome.
Change from Baseline letters per minute at 3 months
SML excels CON in script transcription speed
Time Frame: Change from Baseline letters per minute at 3 months
Assess by WSCT. Speed was derived from the total number of letters written timed 60, divided by the total number of seconds used, and recorded as number of letters per minute. The minimum is 0, and there is no maximum. The higher values represent better treatment outcome.
Change from Baseline letters per minute at 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SML excels CON in Visual Motor Integration
Time Frame: Change from Baseline raw score at 3 months
Assess by the Developmental Test of Visual Motor Integration (DTVMI). The minimum is 0, and the highest is 30. The higher scores represent better treatment outcome
Change from Baseline raw score at 3 months
SML excels CON in Visual Perception
Time Frame: Change from Baseline raw score at 3 months
Assess by the Developmental Test of Visual Motor Integration (DTVMI). The minimum is 0, and the highest is 30. The higher scores represent better treatment outcome.
Change from Baseline raw score at 3 months
SML excels CON in Motor Coordination
Time Frame: Change from Baseline raw score at 3 months
Assess by the Developmental Test of Visual Motor Integration (DTVMI). The minimum is 0, and the highest is 30. The higher scores represent better treatment outcome
Change from Baseline raw score at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mary H. Teng

Investigators

  • Principal Investigator: Mary H Teng, MS, OTR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2012

Primary Completion (Actual)

January 4, 2013

Study Completion (Actual)

June 12, 2013

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 6, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TengM
  • Conventional School-Based OT (Other Identifier: TengM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

I intend to publish this study. I'll make individual participant data (IPD) available to other researchers afterwards.

IPD Sharing Time Frame

I intend to publish this study. I'll make IPD available to other researchers afterwards.

IPD Sharing Access Criteria

I intend to publish this study. I'll make IPD available to other researchers afterwards.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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