My Scrivener® - Measuring Effectiveness and Dose Response in Children

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.

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.

Inclusion Criteria:

• Meet the following base prerequisites for writing: orientation to written language; eye-hand coordination, single handed utensil or tool manipulation (BAMF score >= 6), recognize all letters of the alphabet (unless the child has dyslexia).
• 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:

• Unable to pass the informed assent screener.
• 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