My Scrivener® - Measuring Effectiveness and Dose Response in Children

Obslap Research

Status and phase

Completed

Phase 2

Phase 1

Conditions

Attention Deficit Disorder

Asperger's Syndrome

Traumatic Brain Injury

Stroke

Cerebral Palsy

Dyslexia

ADHD

Treatments

Device: My Scrivener(R)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00919906

#H133S070082 (Other Identifier)

002

Details and patient eligibility

About

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.

Full 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.

Enrollment

176 estimated patients

Sex

All

Ages

5 to 19 years old

Volunteers

No Healthy Volunteers

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