NCT00919906

My Scrivener® - Measuring Effectiveness and Dose Response in Children

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Obslap Research LLC · Industry
• Sex: All
• Age: 5 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

This study will assess whether a computer haptic peripheral device programmed to provide repetitive motion training is as effective as the same repetitive motion training provided by a human being.

Detailed description

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). 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

• Asperger's Syndrome
• Dyslexia
• Cerebral Palsy
• Attention Deficit Disorder
• ADHD
• Traumatic Brain Injury
• Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-06-12
• Last updated: 2010-10-28

Locations

1 site across 1 country: United States