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

Sponsor

Mary H. Teng (Other)

Overall Status

Completed

CT.gov ID

NCT03903614

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Developmental Dysgraphia	Behavioral: SML Behavioral: CON	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

In this study, since the Principal Investigator was the intervener to both study groups, and also the data collector, an effort was made to ensure that both the pre- and posttest were administered in the presence of one other Occupational Therapist, Registered (OTR) and/or a Physical Therapist, who shared the use of the room with Mrs. Teng, test booklets were encrypted, and, that the participants, parents, test graders (one different OTR to each test instrument), and statisticians were kept blind to the group assignment of each participant.

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 12, 2012

Actual Primary Completion Date :

Jan 4, 2013

Actual Study Completion Date :

Jun 12, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

SML excels CON in manuscript letter legibility [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.
SML excels CON in script letter legibility [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.
SML excels CON in manuscript transcription speed [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.
SML excels CON in script transcription speed [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.

Other Outcome Measures

SML excels CON in Visual Motor Integration [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
SML excels CON in Visual Perception [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.
SML excels CON in Motor Coordination [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mary H. Teng

Investigators

Principal Investigator: Mary H Teng, MS, OTR,

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Mary H. Teng, Principal Investigator, Teng, Mary H.

ClinicalTrials.gov Identifier:

NCT03903614

Other Study ID Numbers:

TengM
Conventional School-Based OT
NCT03514992

First Posted:

Apr 4, 2019

Last Update Posted:

Apr 9, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mary H. Teng, Principal Investigator, Teng, Mary H.

Developmental Dysgraphia

Ambidexterity

Outcome study

Additional relevant MeSH terms:

Agraphia

Study Results

No Results Posted as of Apr 9, 2019