Developmental DysgraphiaSMLNCT03903614
Sensory Motor Lateralization as Handwriting Intervention in School-Based OT
A study testing SML and CON in people with Developmental Dysgraphia, run by Mary H. Teng.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Developmental Dysgraphia
- What is being tested?
- SML and CON
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2012to 12 Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All are excluded, if the study candidates have any medical condition(s) that would prohibit them from the full physical participation in school.
About this study
Official title: 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".
Read the 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.
- Conditions
- Developmental Dysgraphia
- Being tested
- SML, CON
- Keywords
- Developmental Dysgraphia, Ambidexterity, Outcome study
- Medical subject headings
- Agraphia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMLBehavioural
Also called Cerebral Lateralization Intervention
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.
CONBehavioural
Also called Conventional School-Based OT
CON consists of supervised handwriting practice, fitness exercises, and fine motor speed drills on the participant's dominant hand.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline letters per minute at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start12 Sep 2012
- Primary completion4 Jan 2013
- Study completion12 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Developmental DysgraphiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary H. Teng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary H. Teng, Teng, Mary H.
- Investigators
- Mary H Teng, MS, OTR, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903614
- Sponsor's protocol ID
- TengM
- Other IDs
- Conventional School-Based OT
- Acronym
- SML
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I intend to publish this study. I'll make individual participant data (IPD) available to other researchers afterwards.
Publications
Adi-Japha E, Landau YE, Frenkel L, Teicher M, Gross-Tsur V, Shalev RS. ADHD and dysgraphia: underlying mechanisms. Cortex. 2007 Aug;43(6):700-9. doi: 10.1016/s0010-9452(08)70499-4.
PubMed 17710822Anguera 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.
PubMed 17996854Assmus 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.
PubMed 15857698Bryden 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.
PubMed 16191813Coghill 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.
PubMed 11387404Corbetta 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.
PubMed 11994752Davidson 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.
PubMed 11107881Hirnstein 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.
PubMed 21035475Hirnstein 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.
PubMed 24427151Hoy 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.
PubMed 21395194Hughes CM, Reissig P, Seegelke C. Motor planning and execution in left- and right-handed individuals during a bimanual grasping and placing task. Acta Psychol (Amst). 2011 Sep;138(1):111-8. doi: 10.1016/j.actpsy.2011.05.013. Epub 2011 Jun 12.
PubMed 21663882Dundas 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.
PubMed 22866684Hlustik 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.
PubMed 12027392Jancke 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.
PubMed 8472554Granert 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.
PubMed 20708692
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handwriting Intervention, With vs. Without a Rightward Bias, in a Junior High School-A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03903614
- Acronym / sponsor ID
- SML / TengM
- Conditions
- Developmental Dysgraphia
- Keywords
- Developmental Dysgraphia, Ambidexterity, Outcome study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mary H. TengUniversity, hospital or other
- Study start
- 12 Sep 2012 (actual)
- Primary completion
- 4 Jan 2013 (actual)
- Study completion
- 12 Jun 2013 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory Motor Lateralization (SML) | Experimental | Behavioral: SMLThis 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. |
| Conventional School-Based OT (CON) | Active comparator | Behavioral: CONThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- All are excluded, if the study candidates have any medical condition(s) that would prohibit them from the full physical participation in school.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMLAlso: Cerebral Lateralization InterventionSML 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. | Behavioural | Sensory Motor Lateralization (SML) |
| CONAlso: Conventional School-Based OTCON consists of supervised handwriting practice, fitness exercises, and fine motor speed drills on the participant's dominant hand. | Behavioural | Conventional School-Based OT (CON) |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Background: PubMed 17710822Adi-Japha E, Landau YE, Frenkel L, Teicher M, Gross-Tsur V, Shalev RS. ADHD and dysgraphia: underlying mechanisms. Cortex. 2007 Aug;43(6):700-9. doi: 10.1016/s0010-9452(08)70499-4.
- Background: PubMed 17996854Anguera 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.
- Background: PubMed 15857698Assmus 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.
- Background: PubMed 16191813Bryden 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.
- Background: PubMed 11387404Coghill 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.
- Background: PubMed 11994752Corbetta 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.
- Background: PubMed 11107881Davidson 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.
- Background: PubMed 21035475Hirnstein 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.
- Background: PubMed 24427151Hirnstein 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.
- Background: PubMed 21395194Hoy 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.
- Background: PubMed 21663882Hughes CM, Reissig P, Seegelke C. Motor planning and execution in left- and right-handed individuals during a bimanual grasping and placing task. Acta Psychol (Amst). 2011 Sep;138(1):111-8. doi: 10.1016/j.actpsy.2011.05.013. Epub 2011 Jun 12.
- Background: PubMed 22866684Dundas 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.
- Bédard, P., Wu, M., \& Sanes, J. N. (2011). Brain Activation Related to Combinations of Gaze Position, Visual Input, and Goal-Directed Hand Movements. Cerebral Cortex, 21(6), 1273-1282.Link provided by the sponsor.
- Corballis, M. C. (2014). Left brain, right brain: facts and fantasies. PLoS Biology, 12(1), e1001767.Link provided by the sponsor.
- Frey, S. H. (2008). Tool use, communicative gesture and cerebral asymmetries in the modern human brain. Archives of Philosophical Transactions of the Royal Society of London Biological Sciences, 363, 1951-7.Link provided by the sponsor.
- Guerraz, M., Blouin, J., \& Vercher, J. L. (2003). From head orientation to head control: evidence of both neck and vestibular involvement in hand drawing. Experimental Brain research, 150, 40-9.Link provided by the sponsor.
- Heilman, K. M., Howell, G., Valenstein, E., \& Rothi, L. (1980). Mirror-reading and writing in association with right-left spatial disorientation. Journal of Neurology, Neurosurgery, and Psychiatry, 43(9), 774-80.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. I intend to publish this study. I'll make individual participant data (IPD) available to other researchers afterwards.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary H Teng, MS, OTR principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing SML and CON in people with Developmental Dysgraphia, run by Mary H. Teng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SML excels CON in manuscript letter legibility (time frame: Change from Baseline percent accuracy score at 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903614, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.