Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00919906
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2009-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
My Scrivener® - Measuring Effectiveness and Dose Response in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020817', 'term': 'Asperger Syndrome'}, {'id': 'D004410', 'term': 'Dyslexia'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-27', 'studyFirstSubmitDate': '2009-06-10', 'studyFirstSubmitQcDate': '2009-06-11', 'lastUpdatePostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Brief Assessment of Fine Motor Skills', 'timeFrame': 'after 20 interventions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['haptic', 'rehabilitation', 'fine-motor skill', 'handwriting'], 'conditions': ["Asperger's Syndrome", 'Dyslexia', 'Cerebral Palsy', 'Attention Deficit Disorder', 'ADHD', 'Traumatic Brain Injury', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '18335049', 'type': 'BACKGROUND', '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.'}, {'pmid': '17140881', 'type': 'BACKGROUND', '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."}, {'pmid': '16915876', 'type': 'BACKGROUND', '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.'}, {'pmid': '16541981', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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."}, {'pmid': '16541980', 'type': 'BACKGROUND', '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.'}, {'pmid': '23106988', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.youtube.com/watch?v=niM5gI26U4o', 'label': '3-minute video of the My Scrivener device'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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).\n\nIndependent variables:\n\n* Tactile feedback is a continuous variable of force-feedback measured in pounds of force.\n* Duration is a continuous variable measured in seconds and number of repetitions.\n* Visual feedback is the letter scribed on the paper.\n\nDependent variable:\n\n* Legible handwriting will be measured by scoring on the Test of Handwriting Skills and the Print Tool™ evaluation.\n* Fine motor deficit/control will be measured directly and objectively by quantifying the error between the desired scribing task and the actual scribing task.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n* Children have illegible printing for their grade, or legible printing but a speed less than the norms for their grade and sex.\n* Be able to grasp a pen.\n* Be able to speak and understand English.\n* Be able to follow instructions.\n* Be able to devote at least 20 minutes to the assigned tasks (short breaks will be allowed).\n* Be enrolled in school at grade K or above.\n* A score lower than 80% on the Print Tool™ or the Cursive Tool.\n\nExclusion Criteria:\n\n* Unable to pass the informed assent screener.\n* Unwilling to sign or mark the informed assent documents.\n* Uncontrolled spasticity.\n* A BAMF score lower than 6 (includes severe paralysis of the upper extremity).\n* Cerebral palsy other than hemiplegia cerebral palsy\n* Severe autism or intellectual disabilities that prevent productive interactions with the investigator'}, 'identificationModule': {'nctId': 'NCT00919906', 'briefTitle': 'My Scrivener® - Measuring Effectiveness and Dose Response in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Obslap Research LLC'}, 'officialTitle': 'My Scrivener® - Measuring Effectiveness and Dose Response in Children', 'orgStudyIdInfo': {'id': '002'}, 'secondaryIdInfos': [{'id': '#H133S070082'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Handwriting without Tears', 'description': 'Standard practice'}, {'type': 'EXPERIMENTAL', 'label': 'Haptic guidance', 'interventionNames': ['Device: My Scrivener(R)']}], 'interventions': [{'name': 'My Scrivener(R)', 'type': 'DEVICE', 'otherNames': ['My Scrivener', 'Falcon, by Novint Technologies', 'Handwriting Without Tears'], 'description': '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.', 'armGroupLabels': ['Haptic guidance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97405', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Susan Palsbo', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Susan E Palsbo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obslap Research LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obslap Research LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Sue Palsbo', 'oldOrganization': 'Obslap Research LLC'}}}}