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| ID | Type | Description | Link |
|---|---|---|---|
| #H133S070082 |
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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.
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:
Dependent variable:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Handwriting without Tears | No Intervention | Standard practice | |
| Haptic guidance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Assessment of Fine Motor Skills | after 20 interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Palsbo, PhD | Obslap Research LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Susan Palsbo | Eugene | Oregon | 97405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18335049 | Background | 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. | |
| 17140881 | 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. |
| Label | URL |
|---|---|
| 3-minute video of the My Scrivener device | View source |
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| ID | Term |
|---|---|
| D020817 | Asperger Syndrome |
| D004410 | Dyslexia |
| D002547 | Cerebral Palsy |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000070642 | Brain Injuries, Traumatic |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| 16915876 | 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. |
| 16541981 | 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. |
| 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. |
| 16541980 | 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. |
| 23106988 | Derived | 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. |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |