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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903614
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mary H. Teng, Teng, Mary H.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 12, 2012
Actual Primary Completion Date : January 4, 2013
Actual Study Completion Date : June 12, 2013

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 Name: 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 Name: Conventional School-Based OT




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903614


Sponsors and Collaborators
Mary H. Teng
Investigators
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Principal Investigator: Mary H Teng, MS, OTR
Additional Information:

Publications:

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Responsible Party: Mary H. Teng, Principal Investigator, Teng, Mary H.
ClinicalTrials.gov Identifier: NCT03903614    
Obsolete Identifiers: NCT03514992
Other Study ID Numbers: TengM
Conventional School-Based OT ( Other Identifier: TengM )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: I intend to publish this study. I'll make individual participant data (IPD) available to other researchers afterwards.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: I intend to publish this study. I'll make IPD available to other researchers afterwards.
Access Criteria: I intend to publish this study. I'll make IPD available to other researchers afterwards.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary H. Teng, Teng, Mary H.:
Developmental Dysgraphia
Ambidexterity
Outcome study
Additional relevant MeSH terms:
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Agraphia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases