My Scrivener® - Measuring Effectiveness and Dose Response in Children

Stroke Clinical Trial

Official title:

My Scrivener® - Measuring Effectiveness and Dose Response in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919906
• Other study ID #: 002
• Secondary ID: #H133S070082
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 10, 2009
• Last updated: October 27, 2010
• Start date: April 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: Obslap Research LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Asperger Syndrome
• Asperger's Syndrome
• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Cerebral Palsy
• Dyslexia
• Stroke
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
United States	Susan Palsbo	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Obslap Research LLC

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beery Motor Coordination Subtest		after 20 interventions	No
Primary	Print Tool and Cursive Tool		after 20 interventions	No
Primary	Deviations from desired 3-D writing path		after 5, 10, 15, 20 interventions	No
Secondary	Brief Assessment of Fine Motor Skills		after 20 interventions	No

External Links

•   3-minute video of the My Scrivener device