Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT05459766
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2022-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2022-07-12', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in functional mobility', 'timeFrame': 'At baseline, at 1 day and 3 days after surgery', 'description': 'It will be assessed using the Timed Up and Go test'}], 'secondaryOutcomes': [{'measure': 'Changes in active and passive knee range of motion', 'timeFrame': 'At baseline, at 1 day and 3 days after surgery', 'description': 'It will be assessed using an inertial measurement unit'}, {'measure': 'Changes in perceived pain', 'timeFrame': 'At baseline and 3 days after surgery', 'description': 'It will be assessed using Numerical Rating Scale (0-10 points), where 0 means no pain and 10 means maximum pain.'}, {'measure': 'Changes in body pain representation at the level of the knee joint', 'timeFrame': 'At baseline and 3 days after surgery', 'description': 'It will be assessed using the Pain Drawing Body Chart'}, {'measure': 'Changes in quadriceps activation failure', 'timeFrame': 'At baseline, at 1 day and 3 days after surgery', 'description': 'It will be assessed using the Quadricpes Activation Battery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Arthoplasty']}, 'descriptionModule': {'briefSummary': "The study is aimed at investigating the effects of action observation and motor imagery training in patients undergoing total knee arthroplasty. Fifty participants will be enrolled during hospital admission and randomized into 2 groups (AO+MI and CTRL groups). AO+MI will undergo 12-minute AO+MI intervention for 3 days (preoperative day, first and second postoperartive days), whereas CTRL group will undergo usual care. At baseline, first and third postoperative days, participants will be assessed for mobility, pain, range of motion, quadriceps acrivation failure and patient's bady-pain representation by a blinded operator."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for total knee arthroplasty\n* age greater or equal to 18 years old\n* ability to walk independently.\n\nExclusion Criteria:\n\n* previous total knee arthoplasty on the contralateral side\n* revision surgery\n* dementia\n* musculoskeletal and neurological disorders influencing functional recovery\n* visual or auditory deficits.\n* postoperative complications\n* weight bearing restrictions\n* lack of walking independency within the second postoperative day.'}, 'identificationModule': {'nctId': 'NCT05459766', 'briefTitle': 'Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Effects of a Perioperative Action Observation and Motor Imagery Training in Patients Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'CLF22/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AO+MI', 'description': 'Video-clips observation representing motor contents, followed by motor imagery (12 minutes a day per 3 days).', 'interventionNames': ['Behavioral: Action observation and motor imagery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CTRL', 'description': 'Usual care, consisting of preoperative education.', 'interventionNames': ['Behavioral: Usual care']}], 'interventions': [{'name': 'Action observation and motor imagery', 'type': 'BEHAVIORAL', 'description': 'Observation and imagination of functional tasks that will be performed during the postoperative rehabilitation program.', 'armGroupLabels': ['AO+MI']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Participants will be educated about the postoperative rehabilitation program', 'armGroupLabels': ['CTRL']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}