My Scrivener® - Measuring Effectiveness and Dose Response in Children
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|ClinicalTrials.gov Identifier: NCT00919906|
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : October 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Asperger's Syndrome Dyslexia Cerebral Palsy Attention Deficit Disorder ADHD Traumatic Brain Injury Stroke||Device: My Scrivener(R)||Phase 1 Phase 2|
This study builds on a large body of neurological research that uses robot-guided repetitive motion training to induce neuroplasticity and improvements in upper extremity motor skills in adults and children. This research study is looking at handwriting, a fine-motor task that is used daily.
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).
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||My Scrivener® - Measuring Effectiveness and Dose Response in Children|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
No Intervention: Handwriting without Tears
|Experimental: Haptic guidance||
Device: 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.
- Beery Motor Coordination Subtest [ Time Frame: after 20 interventions ]
- Print Tool and Cursive Tool [ Time Frame: after 20 interventions ]
- Deviations from desired 3-D writing path [ Time Frame: after 5, 10, 15, 20 interventions ]
- Brief Assessment of Fine Motor Skills [ Time Frame: after 20 interventions ]
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): NCT00919906
|United States, Oregon|
|Eugene, Oregon, United States, 97405|
|Principal Investigator:||Susan E Palsbo, PhD||Obslap Research LLC|