Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-06 @ 7:04 AM
Study NCT ID:
NCT03358160
Status:
UNKNOWN
Last Update Posted:
2017-11-30
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Representations in Orthopedic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000068079', 'term': 'Motor Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-24', 'studyFirstSubmitDate': '2017-11-21', 'studyFirstSubmitQcDate': '2017-11-24', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Group Differences in action discrimination performance.', 'timeFrame': 'End 2018.', 'description': 'Group Differences in action discrimination performance depending on the impairment in movement execution.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder', 'Motor Disorder', 'Perceptual Disorders']}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate the possible effects that a motor limitation at the peripheral level might have on the ability to visually discriminate others' actions.\n\nPrevious literature has shown that specific motor skills (motor expertise) facilitate the visual discrimination of domain-specific actions, and that these motor experts' superior abilities might be mediated by areas not only responsible for the visual recognition of movements (as it happens in non-expert subjects) but also involved in motor planning. Similarly, impairment in the motor system due to neurological damage modulates not only the ability to perform movements but also the ability to discriminate and predict the temporal course of observed actions.\n\nBased on these findings, it has been hypothesized that the motor representations of gait, despite being a hyper-learned motor pattern, might be subjected to modification as a result of an impairment of walking caused by a peripheral functional limitation in the lower limbs as the one characterizing orthopaedic patients who underwent a surgical operation for total knee arthroprosthesis. In this protocol, patients are thus required to perform visual discrimination tasks based on the observation of movements performed with either the upper or lower limbs, and their performance is expected to correlated with their functional impairments in movement execution.\n\nThese results would indicate that the (in)ability to perform a movement might have an impact on its representation at the central level and on internal motion simulation capabilities, which also influence the ability to visual discriminate others' actions through action-perception transfer: this would suggest that rehabilitation in orthopaedic patients should take into account (and restore) such a central impairment in motor representations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Orthopaedic patients and age-matched healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be able to understand instructions and have no history of neurological or psychiatric disorders.\n\nExclusion Criteria:\n\n* History of neurological or psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT03358160', 'briefTitle': 'Motor Representations in Orthopedic Patients', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Motor Representations in Orthopedic Patients: Pilot Studies', 'orgStudyIdInfo': {'id': 'RMPO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TKA', 'description': 'Orthopaedic patients who underwent surgical operation for total knee arthroprothesis.', 'interventionNames': ['Behavioral: Action discrimination tasks.']}, {'label': 'Rizoarthrosis', 'description': 'Orthopaedic patients who underwent surgical operation to treat chronic arthrosis of the thumb.', 'interventionNames': ['Behavioral: Action discrimination tasks.']}, {'label': 'Healthy Controls', 'description': 'Healthy age-matched controls.', 'interventionNames': ['Behavioral: Action discrimination tasks.']}], 'interventions': [{'name': 'Action discrimination tasks.', 'type': 'BEHAVIORAL', 'description': "The investigators will compare the groups' performance during action discrimination tasks related to movements of the upper vs. lower limbs.", 'armGroupLabels': ['Healthy Controls', 'Rizoarthrosis', 'TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Zacchetti', 'role': 'CONTACT', 'email': 'sara.zacchetti@grupposandonato.it', 'phone': '+390266214057'}, {'name': 'Eraldo Paulesu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Galeazzi Orthopedic Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}