Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-28 @ 9:47 PM
Study NCT ID:
NCT00281359
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2006-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], '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': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-04', 'studyFirstSubmitDate': '2006-01-23', 'studyFirstSubmitQcDate': '2006-01-23', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': '12 weeks', 'description': '15 degree change in RoM'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'dynamic splinting', 'contractures', 'heat therapy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.', 'detailedDescription': 'When using active orthoses to treat contractures, is the effectiveness of treatment improved by heating the contracted tissue prior to treatment?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nchildren with cerebral palsy -\n\nExclusion Criteria:\n\nabsent thermal sensation -'}, 'identificationModule': {'nctId': 'NCT00281359', 'briefTitle': 'A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust'}, 'officialTitle': 'A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.', 'orgStudyIdInfo': {'id': 'RL1 230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With heat', 'description': 'heat applied to contracted tissues prior to using the active stretching orthosis.', 'interventionNames': ['Device: With heat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Without heat', 'description': 'No heat applied to the contracted tissues prior to using the stretching orthosis', 'interventionNames': ['Device: No heat']}], 'interventions': [{'name': 'With heat', 'type': 'DEVICE', 'otherNames': ['heat pad followed by dynamic splinting'], 'description': 'heat pad followed by dynamic splinting', 'armGroupLabels': ['With heat']}, {'name': 'No heat', 'type': 'DEVICE', 'description': 'No heat added to tissue prior to dynamic splinting', 'armGroupLabels': ['Without heat']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SY10 7AG', 'city': 'Oswestry', 'state': 'Shropshire', 'country': 'United Kingdom', 'facility': 'Robert Jones and Agnes Hunt Orthopaedic and District Hospital NHS Trust', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}], 'overallOfficials': [{'name': 'John Patrick', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert Jones and Agnes Hunt Orthopaedic Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Action Medical Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}