My Scrivener® - Measuring Effectiveness and Dose Response in Children

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cerebral Palsy; ADHD; Traumatic Brain Injury; Dyslexia; Attention Deficit Disorder; Asperger's Syndrome
• Intervention / Treatment: Device: My Scrivener(R)

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: Interventional
• Enrollment (Anticipated): 176
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97405
      • Susan Palsbo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Brief Assessment of Fine Motor Skills	after 20 interventions

Collaborators and Investigators

• Sponsor: Obslap Research LLC
• Investigators: Principal Investigator: Susan E Palsbo, PhD, Obslap Research LLC

Publications and helpful links

General Publications

• Bluteau J, Coquillart S, Payan Y, Gentaz E. Haptic guidance improves the visuo-manual tracking of trajectories. PLoS One. 2008 Mar 12;3(3):e1775. doi: 10.1371/journal.pone.0001775.
• O'Malley MK, Ro T, Levin HS. Assessing and inducing neuroplasticity with transcranial magnetic stimulation and robotics for motor function. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S59-66. doi: 10.1016/j.apmr.2006.08.332.
• Volman MJ, van Schendel BM, Jongmans MJ. Handwriting difficulties in primary school children: a search for underlying mechanisms. Am J Occup Ther. 2006 Jul-Aug;60(4):451-60. doi: 10.5014/ajot.60.4.451.
• Denton PL, Cope S, Moser C. The effects of sensorimotor-based intervention versus therapeutic practice on improving handwriting performance in 6- to 11-year-old children. Am J Occup Ther. 2006 Jan-Feb;60(1):16-27. doi: 10.5014/ajot.60.1.16.
• Palluel-Germain R, Bara F, Hillairet de Boisferon A, Hennion B, Gouagout P, Gentaz E. 2007. A visuo-haptic device - Telemaque - increases kindergarten children's handwriting acquisition. In proceedings of IEEE World Haptics 2007, pp72-77.
• Marr D, Dimeo SB. Outcomes associated with a summer handwriting course for elementary students. Am J Occup Ther. 2006 Jan-Feb;60(1):10-5. doi: 10.5014/ajot.60.1.10.
• Palsbo SE, Hood-Szivek P. Effect of robotic-assisted three-dimensional repetitive motion to improve hand motor function and control in children with handwriting deficits: a nonrandomized phase 2 device trial. Am J Occup Ther. 2012 Nov-Dec;66(6):682-90. doi: 10.5014/ajot.2012.004556.

Helpful Links

• 3-minute video of the My Scrivener device

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 11, 2009
• First Posted (Estimate): June 12, 2009

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 27, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: rehabilitation; haptic; fine-motor skill; handwriting
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Language Disorders; Communication Disorders; Learning Disabilities; Autism Spectrum Disorder; Cerebral Palsy; Brain Injuries; Brain Injuries, Traumatic; Attention Deficit Disorder with Hyperactivity; Dyslexia; Asperger Syndrome
• Other Study ID Numbers: 002 (University of CT Health Center); #H133S070082 (Other Identifier: NIDRR)