Skip to content

My Scrivener® - Measuring Effectiveness and Dose Response in Children

My Scrivener® - Measuring Effectiveness and Dose Response in Children

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00919906
Enrollment
176
Registered
2009-06-12
Start date
2009-04-30
Completion date
2010-09-30
Last updated
2010-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Asperger's Syndrome, Attention Deficit Disorder, Cerebral Palsy, Dyslexia, Stroke, Traumatic Brain Injury

Keywords

haptic, rehabilitation, fine-motor skill, handwriting

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.

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.

Interventions

DEVICEMy 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.

Sponsors

Obslap Research LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Print Tool and Cursive Toolafter 20 interventions
Deviations from desired 3-D writing pathafter 5, 10, 15, 20 interventions
Beery Motor Coordination Subtestafter 20 interventions

Secondary

MeasureTime frame
Brief Assessment of Fine Motor Skillsafter 20 interventions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026