Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-01-06 @ 10:08 AM
Study NCT ID:
NCT03815734
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2019-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period
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': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-30', 'studyFirstSubmitDate': '2019-01-16', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Preoperative pain to postoperative pain', 'timeFrame': '2 weeks before the surgery/5, 7 and 11 weeks after surgery', 'description': 'Visual Analogue Scale (VAS). "0" (better) to "10" (worse)'}], 'secondaryOutcomes': [{'measure': 'Mobility of hand', 'timeFrame': '2 weeks before the surgery/5, 7 and 11 weeks after surgery', 'description': 'Kapandji test'}, {'measure': 'Joint mobility', 'timeFrame': '2 weeks before the surgery/5, 7 and 11 weeks after surgery', 'description': 'Goniometer'}, {'measure': 'Strength', 'timeFrame': '2 weeks before the surgery/5, 7 and 11 weeks after surgery', 'description': 'Baseline Pinch Gauge, Hydraulic.'}, {'measure': 'Edema/inflammation', 'timeFrame': '2 weeks before the surgery/5, 7 and 11 weeks after surgery', 'description': 'Measuring tape. Centimeter measurement. Wrist and thumb perimeter'}, {'measure': 'Quality of life and function', 'timeFrame': '2 weeks before the surgery/5, 7 and 11 weeks after surgery', 'description': 'The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). 30-item disability/symptom scale, scored 0 (no disability) to 100'}, {'measure': 'Manual function', 'timeFrame': '2 weeks before the surgery/5, 7 and 11 weeks after surgery', 'description': 'The Cochin Hand Functional Scale (CHFS) questionnaire. "0" better to "90" worse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mental practice', 'motor imagery', 'trapeziometacarpal osteoarthritis'], 'conditions': ['Osteoarthritis Thumb', 'Immobilization']}, 'referencesModule': {'references': [{'pmid': '19345768', 'type': 'BACKGROUND', 'citation': 'Stenekes MW, Geertzen JH, Nicolai JP, De Jong BM, Mulder T. Effects of motor imagery on hand function during immobilization after flexor tendon repair. Arch Phys Med Rehabil. 2009 Apr;90(4):553-9. doi: 10.1016/j.apmr.2008.10.029.'}, {'pmid': '40337611', 'type': 'DERIVED', 'citation': 'Prado-Robles E, Delgado-Gil JA, Navarro-Prada SR, Rodriguez-Martin B, Gomez-Martinez M, Seco-Calvo J. The effects of motor imagery on trapeziometacarpal osteoarthritis in women during the post-surgical immobilisation period: A protocol for a randomised clinical trial. Br J Occup Ther. 2023 Aug;86(8):531-539. doi: 10.1177/03080226221137771. Epub 2022 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to verify whether after trapeziometacarpal osteoarthrosis surgery and during the period of immobilization immediately after it, applying motor imagery, improvements are achieved on pain, strength, edema and / or inflammation, function and the joint range, accelerating the recovery process.', 'detailedDescription': 'Motor imagery (IM) consists of a complex cognitive operation by which an action is simulated without doing it physically.\n\nMany studies support the usefulness of motor imaging in rehabilitation after manual surgery.\n\nAn approach based on motor imagery may be useful in trapeziometacarpal osteoarthritis, and may be used to promote motor recovery after surgical treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participants on the surgical waiting list of the Hospital of León\n\nExclusion Criteria:\n\n* Other hand pathologies'}, 'identificationModule': {'nctId': 'NCT03815734', 'briefTitle': 'Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de León'}, 'officialTitle': 'Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period', 'orgStudyIdInfo': {'id': 'SALUDDOCTORADO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Non intervention group'}, {'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'motor imagery group', 'interventionNames': ['Procedure: motor imagery']}], 'interventions': [{'name': 'motor imagery', 'type': 'PROCEDURE', 'description': 'motor imagery during the postoperative immobilization period', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24196', 'city': 'León', 'country': 'Spain', 'facility': 'Eva', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}], 'overallOfficials': [{'name': 'Jesús Seco Calvo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de León'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eva Prado Robles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator. Occupational Therapy', 'investigatorFullName': 'Eva Prado Robles', 'investigatorAffiliation': 'Universidad de León'}}}}