Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-07 @ 9:54 PM
Study NCT ID:
NCT00991692
Status:
COMPLETED
Last Update Posted:
2009-10-08
First Post:
2009-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multisite Trial of ACQUIREc Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D010291', 'term': 'Paresis'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009788', 'term': 'Occupational Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-07', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatric CI Therapy', 'ACQUIREc Therapy', 'Dosage', 'Occupational Therapy', 'Physical Therapy', 'Cerebral Palsy', 'Hemiparesis'], 'conditions': ['Hemiparetic Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '22699104', 'type': 'DERIVED', 'citation': 'DeLuca SC, Case-Smith J, Stevenson R, Ramey SL. Constraint-induced movement therapy (CIMT) for young children with cerebral palsy: effects of therapeutic dosage. J Pediatr Rehabil Med. 2012;5(2):133-42. doi: 10.3233/PRM-2012-0206.'}]}, 'descriptionModule': {'briefSummary': 'A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 3-6 years of age\n* Hemiparetic CP\n\nExclusion Criteria:\n\n* No prior CI therapy treatments\n* No Botox for 6-months'}, 'identificationModule': {'nctId': 'NCT00991692', 'briefTitle': 'A Multisite Trial of ACQUIREc Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Multisite Trial of ACQUIREc Therapy', 'orgStudyIdInfo': {'id': 'deluca-ms1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment dosage levels examined', 'interventionNames': ['Other: Therapy services (ACQUIREc Therapy)']}], 'interventions': [{'name': 'Therapy services (ACQUIREc Therapy)', 'type': 'OTHER', 'otherNames': ['Occupational Therapy', 'Physical Therapy', 'Pediatric CI Therapy', 'ACQUIREc Therapy'], 'description': 'Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.', 'armGroupLabels': ['Treatment dosage levels examined']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35124', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Stephanie C DeLuca, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Stephanie C. DeLuca, PhD', 'oldOrganization': 'UAB'}}}}