My Scrivener® - Measuring Effectiveness and Dose Response in Children

NCT00919906 | Completed Phase 1

• 2 other identifiers: 002#H133S070082
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

haptic; rehabilitation; fine-motor skill; handwriting

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Brief Assessment of Fine Motor Skills

  after 20 interventions

Study Arms (2)

Handwriting without Tears

NO INTERVENTION

Standard practice

Haptic guidance

EXPERIMENTAL

Device: My Scrivener(R)

Interventions

My Scrivener(R) DEVICE

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.

Also known as: My Scrivener, Falcon, by Novint Technologies, Handwriting Without Tears

Haptic guidance

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Obslap Research LLC: lead

Study Sites (1)

Susan Palsbo

Eugene, Oregon, 97405, United States

Location

Related Publications (7)

• 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.

  PMID: 18335049 BACKGROUND

• 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.

  PMID: 17140881 BACKGROUND

• 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.

  PMID: 16915876 BACKGROUND

• 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.

  PMID: 16541981 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16541980 BACKGROUND

• 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.

  PMID: 23106988 DERIVED

Related Links

• 3-minute video of the My Scrivener device

MeSH Terms

Conditions

Asperger Syndrome; Dyslexia; Cerebral Palsy; Attention Deficit Disorder with Hyperactivity; Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Attention Deficit and Disruptive Behavior Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Susan E Palsbo, PhD

  Obslap Research LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 12, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 28, 2010

Record last verified: 2010-10

Locations

US (1)