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Trial record 17 of 41 for:    Developmental Disabilities | ( Map: Oregon, United States )

My Scrivener® - Measuring Effectiveness and Dose Response in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00919906
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
Obslap Research LLC

Tracking Information
First Submitted Date  ICMJE June 10, 2009
First Posted Date  ICMJE June 12, 2009
Last Update Posted Date October 28, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • Beery Motor Coordination Subtest [ Time Frame: after 20 interventions ]
  • Print Tool and Cursive Tool [ Time Frame: after 20 interventions ]
  • Deviations from desired 3-D writing path [ Time Frame: after 5, 10, 15, 20 interventions ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
  • Test of Handwriting Skills-Revised [ Time Frame: after 20 interventions ]
  • Print Tool and Cursive Tool [ Time Frame: after 20 interventions ]
  • Deviations from desired 3-D writing path [ Time Frame: after 5, 10, 15, 20 interventions ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2009)
Brief Assessment of Fine Motor Skills [ Time Frame: after 20 interventions ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE My Scrivener® - Measuring Effectiveness and Dose Response in Children
Official Title  ICMJE My Scrivener® - Measuring Effectiveness and Dose Response in Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Asperger's Syndrome
  • Dyslexia
  • Cerebral Palsy
  • Attention Deficit Disorder
  • ADHD
  • Traumatic Brain Injury
  • Stroke
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: Handwriting without Tears
    Standard practice
  • Experimental: Haptic guidance
    Intervention: Device: My Scrivener(R)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)
176
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00919906
Other Study ID Numbers  ICMJE 002
#H133S070082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sue Palsbo, Obslap Research LLC
Study Sponsor  ICMJE Obslap Research LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan E Palsbo, PhD Obslap Research LLC
PRS Account Obslap Research LLC
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP