My Scrivener® - Measuring Effectiveness and Dose Response in Children

Stroke Clinical Trial

Official title: My Scrivener® - Measuring Effectiveness and Dose Response in Children

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT00919906
• Study type: Interventional
• Source: Obslap Research LLC
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2009
• Completion date: September 2010