Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT04071002
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patients With Distal Radius Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-24', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-24', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'six month', 'description': 'To evaluate pain severity, patient show a point to indicate her/his pain between 0-10 points on a vertical 100mm line. Severity of pain was assessed with VAS in sleep, rest, and activity.'}, {'measure': 'algometer', 'timeFrame': 'six month', 'description': 'An algometer is used to evaluate pain threshold of the patient for distal radioulnar joint, ulnas styloid, m.pronator quadratus, radial styloid, m. flexor pollicis longus, and triangular fibrocartilage complex.The threshold value of pain was recorded by placing the probe against the points. Then, it was gradually increased and reduced to apply a pressure of 1kg / 0.5cm² with 0.5 cm² probe head .'}, {'measure': 'range of motion', 'timeFrame': 'six month', 'description': "An universal goniometer is used to evaluate patient's active motion of joints for wrist and forearm."}, {'measure': 'grip strength', 'timeFrame': 'six month', 'description': "Grip strength was measured by a hand dynamometer according to the American Association of Hand Therapy Association's standard grip strength measurement method. Right/left extremity and their progression are compared in this evaluation."}, {'measure': 'radiographic evaluations', 'timeFrame': 'six month', 'description': 'The posteroanterior (PA) and lateral (L) radiographic measurements were assessed by an experienced hand surgeon to determine the type of fracture, geometry, and associated pathology. Radial length and radial inclination were assessed by PA radiography. Dorsal or volar angulations of the distal fragment were evaluated on the lateral radiography.'}, {'measure': 'Push-Off Test (POT)', 'timeFrame': 'six month', 'description': 'POT was performed to determine the weight transfer strength of the patient to the injured extremity. The test was performed simultaneously and bilaterally by reversing the hand parts of the two hand dynamometers.'}, {'measure': 'Michigan Hand Outcomes Questionnaire (MHOQ)', 'timeFrame': 'six month', 'description': 'MHOQ was used for evaluating the participation and functional levels of the patients. In the questionnaire consisting of 37 questions under six headings, general hand function, daily life activities, pain, work, aesthetics and satisfaction are evaluated. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.'}, {'measure': 'Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH)', 'timeFrame': 'six month', 'description': "It was used to assess the upper extremity functional status of patients from their perspective. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. It includes 11 item. The score on test ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity."}, {'measure': 'Jebsen-Taylor Hand Function Test (JTHFT)', 'timeFrame': 'six month', 'description': 'The seven individual subtests of JTHFT writing, card turning, picking up small common objects, stacking checkers, stimulated feeding, moving light objects and moving heavy objects, were performed as a standardized procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Distal radius fracture', 'functional status', 'activity participation', 'hand therapy'], 'conditions': ['Physical Disability']}, 'referencesModule': {'references': [{'pmid': '24508093', 'type': 'BACKGROUND', 'citation': 'Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'Surgically and conservatively treated distal radius fractures followed for six month. In this period 12 weeks rehabilitation programme applied for each group. Nine different evaluations were done in the initial, after physical therapy and 6th month. Results were presented.', 'detailedDescription': 'Distal radius fracture (DRF) affects overall health status. The International Classification of Function (ICF) based approach is appropriate in the management of DRF. The purpose of this study was to investigate functional status and activity participation levels of DRF patients.\n\nThe patients were divided into conservative and surgical groups and were admitted to 12-weeks rehabilitation period. The evaluation of the body function and structure were done with Visual Analogue Scale, algometer, range of motion (ROM) and grip strength. Also, radiographic evaluations were done. Activity participation assessments were done with Push-Off Test (POT), Michigan Hand Outcomes Questionnaire (MHOQ), Short Form of Disabilities of Arm-Shoulder and Hand Questionnaire (Q-DASH) and Jebsen-Taylor Hand Function Test (JTHFT). Mann-Whitney U and Wilcoxon Tests were used respectively for intergroup and intra-group comparisons. Statistical significance level was p\\<0,05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18 and 60\n* Diagnosed with distal radius fracture\n* Primary fixation after injury.\n\nExclusion Criteria:\n\n* Bilateral distal radius fracture\n* Concomitant ulna styloid fracture\n* Another orthopaedic, neurological or rheumatologic problem involving the ipsilateral upper limb\n* Patients who underwent surgery that involved ipsilateral upper extremity\n* Associated injuries such as nerve or tendon injuries\n* Secondary procedures at follow-up\n* Un-cooperated patients.'}, 'identificationModule': {'nctId': 'NCT04071002', 'briefTitle': 'Patients With Distal Radius Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Functional Status and Activity Participation Levels in Patients With Distal Radius Fracture', 'orgStudyIdInfo': {'id': '3518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'surgical group', 'description': 'distal radius fractures that treated volar plate', 'interventionNames': ['Other: 12 weeks physical therapy programme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conservative group', 'description': 'distal radius fractures that treated plaster of paris', 'interventionNames': ['Other: 12 weeks physical therapy programme']}], 'interventions': [{'name': '12 weeks physical therapy programme', 'type': 'OTHER', 'description': 'The programme include contrast bath, bandage, massage, active exercises, resistive exercises.', 'armGroupLabels': ['conservative group', 'surgical group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Denizli', 'state': 'Kinikli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'HANDE USTA, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale University'}, {'name': 'ALI KITIS, PROF', 'role': 'STUDY_CHAIR', 'affiliation': 'Pamukkale University'}, {'name': 'AHMET FAHIR DEMIRKAN, PROF', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Research Assistant', 'investigatorFullName': 'HANDE USTA', 'investigatorAffiliation': 'Pamukkale University'}}}}