Clinical trial NCT00919906: My Scrivener® - Measuring Effectiveness and Dose Response in Children
Official title: My Scrivener® - Measuring Effectiveness and Dose Response in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Asperger's Syndrome
Dyslexia
Cerebral Palsy
Attention Deficit Disorder
ADHD
Traumatic Brain Injury
Stroke
Keywords: haptic
rehabilitation
fine-motor skill
handwriting
Lead sponsor: Obslap Research LLC
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 176
Sex: ALL
Minimum age (years): 5
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Beery Motor Coordination Subtest
timeFrame: after 20 interventions
measure: Print Tool and Cursive Tool
timeFrame: after 20 interventions
measure: Deviations from desired 3-D writing path
timeFrame: after 5, 10, 15, 20 interventions
Secondary outcomes:
measure: Brief Assessment of Fine Motor Skills
timeFrame: after 20 interventions
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Susan Palsbo
state: Oregon
Study officials:
affiliation: Obslap Research LLC
name: Susan E Palsbo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.apmr.2006.08.332.
citation: 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.
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. doi: 10.5014/ajot.60.1.16.
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.
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. doi: 10.5014/ajot.60.1.10.
citation: 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.