My Scrivener® - Measuring Effectiveness and Dose Response in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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My Scrivener® - Measuring Effectiveness and Dose Response in Children

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

Intervention / Treatment
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* Device: My Scrivener(R)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Handwriting without Tears<br>Standard practice | |
| Experimental: Haptic guidance<br> | Device: My Scrivener(R)<br>* 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.<br>* Other names: Handwriting Without Tears;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haptic, rehabilitation, fine-motor skill, handwriting