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

Primary Purpose

Developmental Dysgraphia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SML
CON
Sponsored by
Mary H. Teng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Developmental Dysgraphia focused on measuring Developmental Dysgraphia, Ambidexterity, Outcome study

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sensory Motor Lateralization (SML)

    Conventional School-Based OT (CON)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    SML excels CON in manuscript letter legibility
    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
    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
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2019
    Last Updated
    April 6, 2019
    Sponsor
    Mary H. Teng
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03903614
    Brief Title
    Sensory Motor Lateralization as Handwriting Intervention in School-Based OT
    Acronym
    SML
    Official Title
    Handwriting Intervention, With vs. Without a Rightward Bias, in a Junior High School-A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 12, 2012 (Actual)
    Primary Completion Date
    January 4, 2013 (Actual)
    Study Completion Date
    June 12, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mary H. Teng

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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".
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Developmental Dysgraphia
    Keywords
    Developmental Dysgraphia, Ambidexterity, Outcome study

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sensory Motor Lateralization (SML)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conventional School-Based OT (CON)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SML
    Other Intervention Name(s)
    Cerebral Lateralization Intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CON
    Other Intervention Name(s)
    Conventional School-Based OT
    Intervention Description
    CON consists of supervised handwriting practice, fitness exercises, and fine motor speed drills on the participant's dominant hand.
    Primary Outcome Measure Information:
    Title
    SML excels CON in manuscript letter legibility
    Description
    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.
    Time Frame
    Change from Baseline percent accuracy score at 3 months
    Title
    SML excels CON in script letter legibility
    Description
    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.
    Time Frame
    Change from Baseline percent accuracy score at 3 months
    Title
    SML excels CON in manuscript transcription speed
    Description
    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.
    Time Frame
    Change from Baseline letters per minute at 3 months
    Title
    SML excels CON in script transcription speed
    Description
    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.
    Time Frame
    Change from Baseline letters per minute at 3 months
    Other Pre-specified Outcome Measures:
    Title
    SML excels CON in Visual Motor Integration
    Description
    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
    Time Frame
    Change from Baseline raw score at 3 months
    Title
    SML excels CON in Visual Perception
    Description
    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.
    Time Frame
    Change from Baseline raw score at 3 months
    Title
    SML excels CON in Motor Coordination
    Description
    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
    Time Frame
    Change from Baseline raw score at 3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary H Teng, MS, OTR
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
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