Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05256420
Status:
UNKNOWN
Last Update Posted:
2022-02-25
First Post:
2022-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Kinesiotape on Postural Control in Non-operated Anterior Cruciate Ligament Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055052', 'term': 'Athletic Tape'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Control Test (MCT)', 'timeFrame': '10 minutes', 'description': "The MCT assesses the responsiveness of the automatic motor system and recovery from unexpected perturbations of the support surface quickly and efficiently. The MCT provides latencies (time in milliseconds between the onset of translation during the MCT and the onset of the participants' response to the translational movement of the support surface). Latencies were the average of the performance of both feet."}, {'measure': 'Unilateral Stance (US).', 'timeFrame': '10 minutes', 'description': 'The US balance check is a test commonly used in clinical practice to assess balance. This assessment quantifies the ability to maintain postural stability while standing on US with EO and closed. The duration of each test is 10 s. The length of each trial is 10 s. Mean center of gravity (COG) sway velocity (º/s), the ratio of the distance travelled by the COG to the time of the trial, was calculated on each leg with EO and with eyes closed (EC).'}, {'measure': 'Star Excursión Balance Test (SEBT).', 'timeFrame': '10 minutes', 'description': 'The SEBT is a test that provides a significant challenge to the postural control system. SEBT involves the participant maintaining a base of support with one leg while reaching maximally in different directions with the opposite leg, without compromising the base of support of the supporting leg \\[Gribble PA, Hertel J. Considerations for normalizing measures of the Star Excursion Balance Test. Measurement in physical education and exercise science, 2003;7(2),89-100\\]. This test has demonstrated high reliability of measurements, showing sensitivity in screening for functional deficits related to musculoskeletal injuries'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Injuries', 'Cruciate Ligament Rupture', 'Anterior Cruciate Ligament Injuries', 'Motor Control', 'Balance']}, 'descriptionModule': {'briefSummary': "Anterior cruciate ligament (ACL) injuries are the most common traumatic knee ligament injuries. This lesion has a devastating influence on patients' activity levels and quality of life. ACL injuries are most frequent between the ages of 15 and 45 years. Individuals who choose conservative treatment must undergo physical therapy to strengthen muscles around the knee, notably the quadriceps femoris and hamstring muscles. It had been described that in absence of surgical treatment, the knee remains unstable and vulnerable to injury having a much poorer prognosis. This study aims to analyze the effectiveness of neuromuscular taping (kinesiotape) compared to placebo in patients with non-operated anterior cruciate ligament rupture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes, diagnosed with ACL rupture (clinical and imaging) between 18 and 60 years old and not yet operated.\n* Rupture isolated or combined with meniscopathy including bucket-handle.\n* Partial or complete ACL rupture.\n\nExclusion Criteria:\n\n* Cognitive impairment that prevents understanding of simple commands.\n* Unhealed wounds in the knee complex.\n* Severe skin diseases and alterations.\n* Previous history of allergy to any type of bandage.\n* Neurological disease with impaired balance.\n* Manifest deformity of the musculoskeletal system'}, 'identificationModule': {'nctId': 'NCT05256420', 'briefTitle': 'Effect of Kinesiotape on Postural Control in Non-operated Anterior Cruciate Ligament Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Effect of Kinesiotape on Postural Control in Subjects With Non-operated Anterior Cruciate Ligament (ACL) Injuries: a Randomized, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': 'KTBALANCE080222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinesiotape', 'description': 'Application of a kinesiotape bandage on the knee.', 'interventionNames': ['Device: Kinesiotape']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Bandage', 'description': 'Application of a sham bandage on the knee.', 'interventionNames': ['Device: Sham Bandage']}], 'interventions': [{'name': 'Kinesiotape', 'type': 'DEVICE', 'description': 'Application of a kinesiotape bandage on the knee.', 'armGroupLabels': ['Kinesiotape']}, {'name': 'Sham Bandage', 'type': 'DEVICE', 'description': 'Application of a sham bandage on the knee.', 'armGroupLabels': ['Sham Bandage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Víctor Navarro López, PhD student', 'role': 'CONTACT', 'email': 'victor.navarro@urjc.es', 'phone': '697371075'}, {'name': 'Isabel María Alguacil Diego, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francisco Molina Rueda, PT PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universidad Rey Juan Carlos', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}], 'centralContacts': [{'name': 'Víctor Navarro López, PhD student', 'role': 'CONTACT', 'email': 'victor.navarro@urjc.es', 'phone': '697371075'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Josue Fernandez Carnero', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}