NCT03903614

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".

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2013

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

April 3, 2019

Last Update Submit

April 6, 2019

Conditions

Keywords

Developmental DysgraphiaAmbidexterityOutcome study

Outcome Measures

Primary Outcomes (4)

  • 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.

    Change from Baseline percent accuracy score at 3 months

  • 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.

    Change from Baseline percent accuracy score at 3 months

  • 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.

    Change from Baseline letters per minute at 3 months

  • 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.

    Change from Baseline letters per minute at 3 months

Other Outcomes (3)

  • SML excels CON in Visual Motor Integration

    Change from Baseline raw score at 3 months

  • SML excels CON in Visual Perception

    Change from Baseline raw score at 3 months

  • SML excels CON in Motor Coordination

    Change from Baseline raw score at 3 months

Study Arms (2)

Sensory Motor Lateralization (SML)

EXPERIMENTAL

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

Conventional School-Based OT (CON)

ACTIVE COMPARATOR

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

Interventions

SMLBEHAVIORAL

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.

Also known as: Cerebral Lateralization Intervention
Sensory Motor Lateralization (SML)
CONBEHAVIORAL

CON consists of supervised handwriting practice, fitness exercises, and fine motor speed drills on the participant's dominant hand.

Also known as: Conventional School-Based OT
Conventional School-Based OT (CON)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (23)

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    PMID: 17710822BACKGROUND
  • Anguera JA, Russell CA, Noll DC, Seidler RD. Neural correlates associated with intermanual transfer of sensorimotor adaptation. Brain Res. 2007 Dec 14;1185:136-51. doi: 10.1016/j.brainres.2007.09.088. Epub 2007 Oct 11.

    PMID: 17996854BACKGROUND
  • Assmus A, Marshall JC, Noth J, Zilles K, Fink GR. Difficulty of perceptual spatiotemporal integration modulates the neural activity of left inferior parietal cortex. Neuroscience. 2005;132(4):923-7. doi: 10.1016/j.neuroscience.2005.01.047.

    PMID: 15857698BACKGROUND
  • Bryden PJ, Bruyn J, Fletcher P. Handedness and health: an examination of the association between different handedness classifications and health disorders. Laterality. 2005 Sep;10(5):429-40. doi: 10.1080/13576500442000193.

    PMID: 16191813BACKGROUND
  • Coghill RC, Gilron I, Iadarola MJ. Hemispheric lateralization of somatosensory processing. J Neurophysiol. 2001 Jun;85(6):2602-12. doi: 10.1152/jn.2001.85.6.2602.

    PMID: 11387404BACKGROUND
  • Corbetta M, Shulman GL. Control of goal-directed and stimulus-driven attention in the brain. Nat Rev Neurosci. 2002 Mar;3(3):201-15. doi: 10.1038/nrn755.

    PMID: 11994752BACKGROUND
  • Davidson RJ, Jackson DC, Kalin NH. Emotion, plasticity, context, and regulation: perspectives from affective neuroscience. Psychol Bull. 2000 Nov;126(6):890-909. doi: 10.1037/0033-2909.126.6.890.

    PMID: 11107881BACKGROUND
  • Hirnstein M, Bayer U, Ellison A, Hausmann M. TMS over the left angular gyrus impairs the ability to discriminate left from right. Neuropsychologia. 2011 Jan;49(1):29-33. doi: 10.1016/j.neuropsychologia.2010.10.028. Epub 2010 Oct 28.

    PMID: 21035475BACKGROUND
  • Hirnstein M, Hugdahl K, Hausmann M. How brain asymmetry relates to performance - a large-scale dichotic listening study. Front Psychol. 2014 Jan 2;4:997. doi: 10.3389/fpsyg.2013.00997. eCollection 2014.

    PMID: 24427151BACKGROUND
  • Hoy MM, Egan MY, Feder KP. A systematic review of interventions to improve handwriting. Can J Occup Ther. 2011 Feb;78(1):13-25. doi: 10.2182/cjot.2011.78.1.3.

    PMID: 21395194BACKGROUND
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    PMID: 21663882BACKGROUND
  • Dundas EM, Plaut DC, Behrmann M. The joint development of hemispheric lateralization for words and faces. J Exp Psychol Gen. 2013 May;142(2):348-58. doi: 10.1037/a0029503. Epub 2012 Aug 6.

    PMID: 22866684BACKGROUND
  • Hlustik P, Solodkin A, Gullapalli RP, Noll DC, Small SL. Functional lateralization of the human premotor cortex during sequential movements. Brain Cogn. 2002 Jun;49(1):54-62. doi: 10.1006/brcg.2001.1483.

    PMID: 12027392BACKGROUND
  • Jancke L. A differential effect of concurrent verbal activity on right arm movements rightwards and leftwards. Cortex. 1993 Mar;29(1):161-6. doi: 10.1016/s0010-9452(13)80221-3.

    PMID: 8472554BACKGROUND
  • Granert O, Peller M, Gaser C, Groppa S, Hallett M, Knutzen A, Deuschl G, Zeuner KE, Siebner HR. Manual activity shapes structure and function in contralateral human motor hand area. Neuroimage. 2011 Jan 1;54(1):32-41. doi: 10.1016/j.neuroimage.2010.08.013. Epub 2010 Aug 12.

    PMID: 20708692BACKGROUND
  • Schott GD. Mirror writing: neurological reflections on an unusual phenomenon. J Neurol Neurosurg Psychiatry. 2007 Jan;78(1):5-13. doi: 10.1136/jnnp.2006.094870. Epub 2006 Sep 8.

    PMID: 16963501BACKGROUND
  • Sabate M, Gonzalez B, Rodriguez M. Brain lateralization of motor imagery: motor planning asymmetry as a cause of movement lateralization. Neuropsychologia. 2004;42(8):1041-9. doi: 10.1016/j.neuropsychologia.2003.12.015.

    PMID: 15093143BACKGROUND
  • Saugstad LF. Cerebral lateralisation and rate of maturation. Int J Psychophysiol. 1998 Jan;28(1):37-62. doi: 10.1016/s0167-8760(97)00063-9.

    PMID: 9506310BACKGROUND
  • Lee DR, Kim YH, Kim DA, Lee JA, Hwang PW, Lee MJ, You SH. Innovative strength training-induced neuroplasticity and increased muscle size and strength in children with spastic cerebral palsy: an experimenter-blind case study--three-month follow-up. NeuroRehabilitation. 2014;35(1):131-6. doi: 10.3233/NRE-131036.

    PMID: 24419014BACKGROUND
  • Mazziotta JC, Phelps ME. Human sensory stimulation and deprivation: positron emission tomographic results and strategies. Ann Neurol. 1984;15 Suppl:S50-60. doi: 10.1002/ana.410150711.

    PMID: 6611127BACKGROUND
  • Peters M, Reimers S, Manning JT. Hand preference for writing and associations with selected demographic and behavioral variables in 255,100 subjects: the BBC internet study. Brain Cogn. 2006 Nov;62(2):177-89. doi: 10.1016/j.bandc.2006.04.005. Epub 2006 Jun 23.

    PMID: 16797814BACKGROUND
  • Vingerhoets G, Acke F, Alderweireldt AS, Nys J, Vandemaele P, Achten E. Cerebral lateralization of praxis in right- and left-handedness: same pattern, different strength. Hum Brain Mapp. 2012 Apr;33(4):763-77. doi: 10.1002/hbm.21247. Epub 2011 Apr 15.

    PMID: 21500314BACKGROUND
  • Vingerhoets G, Sarrechia I. Individual differences in degree of handedness and somesthetic asymmetry predict individual differences in left-right confusion. Behav Brain Res. 2009 Dec 1;204(1):212-6. doi: 10.1016/j.bbr.2009.06.004. Epub 2009 Jun 10.

    PMID: 19523492BACKGROUND

Related Links

MeSH Terms

Conditions

Agraphia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mary H Teng, MS, OTR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 4, 2019

Study Start

September 12, 2012

Primary Completion

January 4, 2013

Study Completion

June 12, 2013

Last Updated

April 9, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.