My Scrivener® - Measuring Effectiveness and Dose Response in Children

This study has been completed.
Sponsor:
Information provided by:
Obslap Research LLC
ClinicalTrials.gov Identifier:
NCT00919906
First received: June 10, 2009
Last updated: October 27, 2010
Last verified: October 2010
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: My Scrivener® - Measuring Effectiveness and Dose Response in Children

Resource links provided by NLM:


Further study details as provided by Obslap Research LLC:

Primary Outcome Measures:
  • Beery Motor Coordination Subtest [ Time Frame: after 20 interventions ] [ Designated as safety issue: No ]
  • Print Tool and Cursive Tool [ Time Frame: after 20 interventions ] [ Designated as safety issue: No ]
  • Deviations from desired 3-D writing path [ Time Frame: after 5, 10, 15, 20 interventions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief Assessment of Fine Motor Skills [ Time Frame: after 20 interventions ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919906

Locations
United States, Oregon
Susan Palsbo
Eugene, Oregon, United States, 97405
Sponsors and Collaborators
Obslap Research LLC
Investigators
Principal Investigator: Susan E Palsbo, PhD Obslap Research LLC
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sue Palsbo, Obslap Research LLC
ClinicalTrials.gov Identifier: NCT00919906     History of Changes
Other Study ID Numbers: 002, #H133S070082
Study First Received: June 10, 2009
Last Updated: October 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Obslap Research LLC:
haptic
rehabilitation
fine-motor skill
handwriting

Additional relevant MeSH terms:
Dyslexia
Cerebral Palsy
Stroke
Attention Deficit Disorder with Hyperactivity
Asperger Syndrome
Brain Injuries
Wounds and Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Child Development Disorders, Pervasive
Craniocerebral Trauma
Trauma, Nervous System
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Learning Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014