My Scrivener® - Measuring Effectiveness and Dose Response in Children
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.
Attention Deficit Disorder
Traumatic Brain Injury
Device: My Scrivener(R)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||My Scrivener® - Measuring Effectiveness and Dose Response in Children|
- Beery Motor Coordination Subtest [ Time Frame: after 20 interventions ] [ Designated as safety issue: No ]
- Print Tool and Cursive Tool [ Time Frame: after 20 interventions ] [ Designated as safety issue: No ]
- Deviations from desired 3-D writing path [ Time Frame: after 5, 10, 15, 20 interventions ] [ Designated as safety issue: No ]
- Brief Assessment of Fine Motor Skills [ Time Frame: after 20 interventions ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919906
|United States, Oregon|
|Eugene, Oregon, United States, 97405|
|Principal Investigator:||Susan E Palsbo, PhD||Obslap Research LLC|