Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 8:50 AM
Study NCT ID:
NCT05188560
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2021-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in functional mobility using Timed Up and Go test (TUG).', 'timeFrame': 'Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.', 'description': 'The primary outcome is to investigate whether a single administration consisting of two sessions of AOT and MI performed the day before the total hip arthroplasty may impact on functional recovery in the immediate post-operative period. Functional mobility will be evaluated with Timed Up and Go test.'}], 'secondaryOutcomes': [{'measure': 'Changes in maximum gait speed', 'timeFrame': 'Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.', 'description': 'Changes in maximum gait speed between and within groups will be evaluated with 10 meters-walking test (10 MWT).'}, {'measure': 'Changes in pain using Visual Analogue Scale (VAS)', 'timeFrame': 'Both groups will be evaluated the day before (T0) and 4 days after (T1) surgery.', 'description': 'Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Action observation therapy', 'motor imagery', 'Hip arthroplasty', 'functional recovery'], 'conditions': ['Hip Osteoarthritis', 'Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': 'Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Previous studies reported that functional recovery is facilitated by asking patient observing videos with motor content (AOT) and after imagining (MI) the gestures observed. These rehabilitative apporach have been used in particular to promote functional recovery in patients with neuromotor problems, in particular in patients with stroke. To date, few studies have investigated the effectiveness of this therapeutic approach in functional recovery after orthopedic surgery and none of these applied AOT and MI in a single pre-operative session. The objective of the study is to verify whether a single administration consisting of two pre-operative sessions of AOT associated with MI can lead to an improvement of functional recovery in hip arthroplasty patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Total hip arthroplasty (THA) monolateral, first implant\n* Locomotor autonomy with or without aids before surgery\n* BMI (regular, overweight, Grade I obesity)\n* No complications in surgery\n* Orthopaedic prescription of tolerance load on the limb\n* Autonomy with aids within the third post-operative day\n\nExclusion Criteria:\n\n* Previous total hip replacement on contralateral hip\n* Dementia or other conditions affecting patient's collaboration\n* Unresolved clinical complications in the first two post-operative days\n* Neurological, musculoskeletal or other disorders able to impact on functional recovery\n* Visual or auditory deficits\n* Total or partial revisions of THA\n* Patients assigned to different groups hospitalized in the same room"}, 'identificationModule': {'nctId': 'NCT05188560', 'briefTitle': 'Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Efficacy of a Single Preoperative Administration of Action Observation Therapy Associated With Motor Imagery in Patients Undergoing Total Hip Arthroplasty.', 'orgStudyIdInfo': {'id': '750'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AOT+MI', 'description': 'participants who, in addiction to standard rehabilitation program after surgery, underwent a single pre-operative training session of action observation therapy associated with motor imagery.', 'interventionNames': ['Other: Action observation therapy', 'Other: motor imagery']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants who was not subjected to any pre-operative activity. They received standard rehabilitation program after surgery too.'}], 'interventions': [{'name': 'Action observation therapy', 'type': 'OTHER', 'description': 'Subject is asked to observe videos with motor contents', 'armGroupLabels': ['AOT+MI']}, {'name': 'motor imagery', 'type': 'OTHER', 'description': 'mental simulation of a motor task', 'armGroupLabels': ['AOT+MI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}