My Scrivener® - Measuring Effectiveness and Dose Response in Children

Sponsor

Obslap Research LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00919906

Collaborator

(none)

176

Enrollment

Location

Arms

Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asperger's Syndrome Dyslexia Cerebral Palsy Attention Deficit Disorder ADHD Traumatic Brain Injury Stroke	Device: My Scrivener(R)	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

My Scrivener® - Measuring Effectiveness and Dose Response in Children

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Handwriting without Tears Standard practice
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. Other Names: My Scrivener Falcon, by Novint Technologies Handwriting Without Tears

Arm

Intervention/Treatment

No Intervention: Handwriting without Tears

Standard practice

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.

Other Names:

My Scrivener

Falcon, by Novint Technologies

Handwriting Without Tears

Outcome Measures

Primary Outcome Measures

Beery Motor Coordination Subtest [after 20 interventions]
Print Tool and Cursive Tool [after 20 interventions]
Deviations from desired 3-D writing path [after 5, 10, 15, 20 interventions]

Secondary Outcome Measures

Brief Assessment of Fine Motor Skills [after 20 interventions]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 19 Years

Sexes Eligible for Study:

All

Accepts 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