My Scrivener® - Measuring Effectiveness and Dose Response in Children
NCT ID: NCT00919906
Last Updated: 2010-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
176 participants
INTERVENTIONAL
2009-04-30
2010-09-30
Brief Summary
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Detailed Description
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In our study, we want to see if 3-dimensional robotic-assisted repetitive motion training can be a safe and effective intervention for school-age children with fine motor deficits arising from several different impairment origins. Our research construct is: Legible handwriting = function of (tactile feedback, visual feedback, duration, and fine-motor control).
Independent variables:
* Tactile feedback is a continuous variable of force-feedback measured in pounds of force.
* Duration is a continuous variable measured in seconds and number of repetitions.
* Visual feedback is the letter scribed on the paper.
Dependent variable:
* Legible handwriting will be measured by scoring on the Test of Handwriting Skills and the Print Tool™ evaluation.
* Fine motor deficit/control will be measured directly and objectively by quantifying the error between the desired scribing task and the actual scribing task.
The robotic device is an affordable (\<$200) computer haptic (the Falcon(R)) that currently is approved by the FCC for home and office. It is \*not\* approved for medical use. This is an investigational, nonsignificant risk device.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Handwriting without Tears
Standard practice
No interventions assigned to this group
Haptic guidance
My Scrivener(R)
Twenty 20-minute sessions of the Handwriting Without Tears(R) instructional handwriting program, with substitution of hand-over-hand or self-generated repetitive motion writing by computer guided repetitive motion.
Interventions
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My Scrivener(R)
Twenty 20-minute sessions of the Handwriting Without Tears(R) instructional handwriting program, with substitution of hand-over-hand or self-generated repetitive motion writing by computer guided repetitive motion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Children have illegible printing for their grade, or legible printing but a speed less than the norms for their grade and sex.
* Be able to grasp a pen.
* Be able to speak and understand English.
* Be able to follow instructions.
* Be able to devote at least 20 minutes to the assigned tasks (short breaks will be allowed).
* Be enrolled in school at grade K or above.
* A score lower than 80% on the Print Tool™ or the Cursive Tool.
Exclusion Criteria
* Unwilling to sign or mark the informed assent documents.
* Uncontrolled spasticity.
* A BAMF score lower than 6 (includes severe paralysis of the upper extremity).
* Cerebral palsy other than hemiplegia cerebral palsy
* Severe autism or intellectual disabilities that prevent productive interactions with the investigator
5 Years
19 Years
ALL
No
Sponsors
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Obslap Research LLC
INDUSTRY
Responsible Party
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Obslap Research LLC
Principal Investigators
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Susan E Palsbo, PhD
Role: PRINCIPAL_INVESTIGATOR
Obslap Research LLC
Locations
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Susan Palsbo
Eugene, Oregon, United States
Countries
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References
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Bluteau J, Coquillart S, Payan Y, Gentaz E. Haptic guidance improves the visuo-manual tracking of trajectories. PLoS One. 2008 Mar 12;3(3):e1775. doi: 10.1371/journal.pone.0001775.
O'Malley MK, Ro T, Levin HS. Assessing and inducing neuroplasticity with transcranial magnetic stimulation and robotics for motor function. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S59-66. doi: 10.1016/j.apmr.2006.08.332.
Volman MJ, van Schendel BM, Jongmans MJ. Handwriting difficulties in primary school children: a search for underlying mechanisms. Am J Occup Ther. 2006 Jul-Aug;60(4):451-60. doi: 10.5014/ajot.60.4.451.
Denton PL, Cope S, Moser C. The effects of sensorimotor-based intervention versus therapeutic practice on improving handwriting performance in 6- to 11-year-old children. Am J Occup Ther. 2006 Jan-Feb;60(1):16-27. doi: 10.5014/ajot.60.1.16.
Palluel-Germain R, Bara F, Hillairet de Boisferon A, Hennion B, Gouagout P, Gentaz E. 2007. A visuo-haptic device - Telemaque - increases kindergarten children's handwriting acquisition. In proceedings of IEEE World Haptics 2007, pp72-77.
Marr D, Dimeo SB. Outcomes associated with a summer handwriting course for elementary students. Am J Occup Ther. 2006 Jan-Feb;60(1):10-5. doi: 10.5014/ajot.60.1.10.
Palsbo SE, Hood-Szivek P. Effect of robotic-assisted three-dimensional repetitive motion to improve hand motor function and control in children with handwriting deficits: a nonrandomized phase 2 device trial. Am J Occup Ther. 2012 Nov-Dec;66(6):682-90. doi: 10.5014/ajot.2012.004556.
Related Links
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3-minute video of the My Scrivener device
Other Identifiers
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#H133S070082
Identifier Type: -
Identifier Source: secondary_id
002
Identifier Type: -
Identifier Source: org_study_id