Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-03 @ 7:40 AM
Study NCT ID:
NCT03937492
Status:
UNKNOWN
Last Update Posted:
2019-05-03
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range Of Motion', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change in active and passive range of motion about hand and wrist'}], 'secondaryOutcomes': [{'measure': 'Patient-rated wrist/hand evaluation (prwhe)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Decrease in difficulty of doing activities of daily living and decrease pain'}, {'measure': 'Jamar hand dynamometer', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Improve strength'}, {'measure': 'McGill pain questionnaire', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Decrease pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GMI', 'CRPS', 'Distal radius fracture'], 'conditions': ['Wrist Fracture', 'CRPS (Complex Regional Pain Syndromes)', 'Distal Radius Fracture', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The study would like show that patients who follow a protocol with GMI are less probability to develop CRPS', 'detailedDescription': 'Distal radius fractures (DRF) has a high frequency in adults. Studies show that the upper limb is frequently affected by CRPS, especially if is preceded by a fracture.\n\nRecent studies suggest that changes in cortical structures can contribute to the onset of CRPS.\n\nGMI is a approved and efficacy method in CRPS rehabilitation, because it trains modified cortical areas throught 3 stadies: left-right discrimination, visual motor imagery and mirror therapy.\n\nLiterature shows that there are any studies about GMI efficacy on prevention CRPS in DRF after surgery.\n\nThis study would like to demostrate that, appling GMI in the early stages of rehabilitation plus standard rehabilitation protocol of DRF after surgery, CRPS cases are reducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with distal radius fracture after surgery\n* 18 to 75 years old\n* Male and female\n\nExclusion Criteria:\n\n* uncompliants patients\n* patients with neurological disorders or cognitive impairment\n* patients with TFCC injury or both ulna and radius fractures\n* patients with visually impairment\n* patients who don't speak or understand oral and written italian language"}, 'identificationModule': {'nctId': 'NCT03937492', 'briefTitle': 'EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY', 'organization': {'class': 'OTHER', 'fullName': 'Ergoterapia Manoegomito Sagl'}, 'officialTitle': 'EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL', 'orgStudyIdInfo': {'id': 'Ergoterapia manoegomito'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A group', 'description': 'In this group patients follow standard treatment after radius fracture plus GMI procol', 'interventionNames': ['Other: GMI protocol', 'Other: Standard Rehabilitation Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B group', 'description': 'In this group patients follow standard treatment after radius fracture', 'interventionNames': ['Other: Standard Rehabilitation Protocol']}], 'interventions': [{'name': 'GMI protocol', 'type': 'OTHER', 'description': 'This group follow GMI program split in 3 step:\n\n1. left/right descrimination\n2. visual motor imagery\n3. mirror therapy\n\nPatients perform this exercises 3 times every day and they have checks in therapy al least twice a week.', 'armGroupLabels': ['A group']}, {'name': 'Standard Rehabilitation Protocol', 'type': 'OTHER', 'description': 'This group follow standard rehabilitation protocol, with active and passive motion of upper limb structure, including hand, wrist, elbow, shoulder.\n\nPatients perform this exercises 3 times every day and they have checks in therapy al least twice a week.', 'armGroupLabels': ['A group', 'B group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Susanna Pagella', 'role': 'CONTACT', 'email': 'pagella87@gmail.com', 'phone': '00393283092462'}, {'name': 'Alessandra Viola', 'role': 'CONTACT', 'email': 'alessandra.viola92@gmail.com', 'phone': '00393482437807'}], 'overallOfficials': [{'name': 'Susanna Pagella', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ergoterapia Manoegomito Sagl'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ergoterapia Manoegomito Sagl', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pagella Susanna', 'investigatorAffiliation': 'Ergoterapia Manoegomito Sagl'}}}}