Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT06448832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship of Muscular Agenesis: Thin Plantar and Palmar Long as a Biomarker of Injury and Performance Marker in the Lower Limb and Upper Limb Respectively
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of injury', 'timeFrame': 'At the start of the study (at baseline, 0 week).', 'description': 'Presence of injury related to the upper and lower limb.'}], 'secondaryOutcomes': [{'measure': 'Strength', 'timeFrame': 'At the start of the study (at baseline, 0 week)', 'description': 'Upper and lower limb strength'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle agenesis', 'thin plantar', 'force', 'injuries', 'musculoskeletal palmar long', 'performance'], 'conditions': ['Abnormality, Congenital']}, 'referencesModule': {'references': [{'pmid': '25555023', 'type': 'BACKGROUND', 'citation': 'Balsalobre-Fernandez C, Glaister M, Lockey RA. The validity and reliability of an iPhone app for measuring vertical jump performance. J Sports Sci. 2015;33(15):1574-9. doi: 10.1080/02640414.2014.996184. Epub 2015 Jan 2.'}, {'pmid': '26491493', 'type': 'BACKGROUND', 'citation': "Ioannis D, Anastasios K, Konstantinos N, Lazaros K, Georgios N. Palmaris Longus Muscle's Prevalence in Different Nations and Interesting Anatomical Variations: Review of the Literature. J Clin Med Res. 2015 Nov;7(11):825-30. doi: 10.14740/jocmr2243w. Epub 2015 Sep 25."}, {'pmid': '29791956', 'type': 'BACKGROUND', 'citation': 'Vanhoenacker FM, Desimpel J, Mespreuve M, Tagliafico A. Accessory Muscles of the Extremities. Semin Musculoskelet Radiol. 2018 Jul;22(3):275-285. doi: 10.1055/s-0038-1641575. Epub 2018 May 23.'}, {'pmid': '20486022', 'type': 'BACKGROUND', 'citation': 'Martinoli C, Perez MM, Padua L, Valle M, Capaccio E, Altafini L, Michaud J, Tagliafico A. Muscle variants of the upper and lower limb (with anatomical correlation). Semin Musculoskelet Radiol. 2010 Jun;14(2):106-21. doi: 10.1055/s-0030-1253155. Epub 2010 May 18.'}, {'pmid': '21107568', 'type': 'BACKGROUND', 'citation': 'Eric M, Koprivcic I, Vucinic N, Radic R, Krivokuca D, Leksan I, Selthofer R. Prevalence of the palmaris longus in relation to the hand dominance. Surg Radiol Anat. 2011 Aug;33(6):481-4. doi: 10.1007/s00276-010-0751-0. Epub 2010 Nov 24.'}, {'pmid': '30150961', 'type': 'BACKGROUND', 'citation': 'Dabrowski K, Stankiewicz-Jozwicka H, Kowalczyk A, Markuszewski M, Ciszek B. Musculus Palmaris Longus: Influence on Playing Capability of Keyboard Musicians - Preliminary Report. Front Psychol. 2018 Aug 13;9:1460. doi: 10.3389/fpsyg.2018.01460. eCollection 2018.'}, {'pmid': '27682306', 'type': 'BACKGROUND', 'citation': 'Vucinic N, Eric M, Savic M. How often absence of palmaris longus and functional deficiencyof flexor digitorum superficialis occurs ? Acta Orthop Belg. 2016 Aug;82(2):405-411.'}, {'pmid': '22801514', 'type': 'BACKGROUND', 'citation': 'Amaral JF, Mancini M, Novo Junior JM. Comparison of three hand dynamometers in relation to the accuracy and precision of the measurements. Rev Bras Fisioter. 2012 Jun;16(3):216-24. doi: 10.1590/s1413-35552012000300007.'}, {'pmid': '29071305', 'type': 'BACKGROUND', 'citation': 'Chamorro C, Armijo-Olivo S, De la Fuente C, Fuentes J, Javier Chirosa L. Absolute Reliability and Concurrent Validity of Hand Held Dynamometry and Isokinetic Dynamometry in the Hip, Knee and Ankle Joint: Systematic Review and Meta-analysis. Open Med (Wars). 2017 Oct 17;12:359-375. doi: 10.1515/med-2017-0052. eCollection 2017.'}, {'pmid': '18503813', 'type': 'BACKGROUND', 'citation': 'Pua YH, Wrigley TV, Cowan SM, Bennell KL. Intrarater test-retest reliability of hip range of motion and hip muscle strength measurements in persons with hip osteoarthritis. Arch Phys Med Rehabil. 2008 Jun;89(6):1146-54. doi: 10.1016/j.apmr.2007.10.028.'}, {'pmid': '19661831', 'type': 'BACKGROUND', 'citation': 'Arnold CM, Warkentin KD, Chilibeck PD, Magnus CR. The reliability and validity of handheld dynamometry for the measurement of lower-extremity muscle strength in older adults. J Strength Cond Res. 2010 Mar;24(3):815-24. doi: 10.1519/JSC.0b013e3181aa36b8.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates muscle agenesis, specifically the absence of the palmaris longus and plantaris muscles, and its effects on injury risk, strength, and performance. Muscle injuries are common in sports, and the presence or absence of certain muscles can impact biomechanics and injury susceptibility. The study involves 132 subjects, divided into those with and without muscle agenesis, assessing injuries with the Nordic and CMDQ questionnaires and measuring strength with dynamometers. Results aim to clarify the controversial impact of muscle agenesis on functional disability and performance adaptation in the scientific literature.', 'detailedDescription': "Background. This study examines muscle agenesis, a congenital condition that involves the absence of a muscle, focusing on the palmaris longus and plantaris muscles. The prevalence of palmaris longus agenesis varies significantly, and there is debate about whether its absence results in functional disability or is a predictor of injuries. Muscle injuries account for one-third of sports injuries and more than 30% of all musculoskeletal system injuries. The presence or absence of certain muscles can influence the body's biomechanics and, therefore, susceptibility to injuries, as muscles play a crucial role in generating force and coordination, hence movement. The absence of certain muscles may require other muscles to compensate, which could affect the efficiency and performance capacity in certain body areas. However, in many cases, the absence of a muscle may not have a significant effect on performance, as other muscles can adapt to perform its function. This study seeks to provide clarity in this area of research due to the existing controversy in the scientific literature.\n\nObjectives. To determine if muscle agenesis influences the development of injuries and its impact on strength and performance.\n\nMaterial and methods. An observational analytical cross-sectional study was conducted with 132 subjects divided into one group of 66 subjects with muscle agenesis and another group of 66 subjects without muscle agenesis. The primary variable is the presence of upper and lower limb injuries measured using the Nordic and CMDQ questionnaires, and the secondary variable is upper limb strength measured with a dynamometer in palmar flexion and hand grip tests; and lower limb strength measured with a dynamometer in plantar flexion and vertical jump tests. The measurements were taken over 1 hour and 30 minutes during two days, with a 48-hour interval between the measurements of the upper and lower limbs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with and without muscle agenesis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who lead a sedentary lifestyle or who are not used to doing physical training on a regular basis (more than 2 h/week).\n* People between 18 and 80 years old.\n\nExclusion Criteria:\n\n* Individuals with an ongoing oncological process.\n* People with an active infectious process.\n* Subjects with psychiatric disorders.\n* Individuals with intellectual disorders that prevent understanding of the intervention.\n* People with judicial incapacity.\n* Patients diagnosed with fibromyalgia.\n* Pregnancy or probability of pregnancy.\n* Individuals with sensory impairments in the hand that prevent manual pressure.'}, 'identificationModule': {'nctId': 'NCT06448832', 'acronym': 'MA-TP-PL', 'briefTitle': 'Relationship of Muscular Agenesis: Thin Plantar and Palmar Long as a Biomarker of Injury and Performance Marker in the Lower Limb and Upper Limb Respectively', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Relationship of Muscular Agenesis: Thin Plantar and Palmar Long as a Biomarker of Injury and Performance Marker in the Lower Limb and Upper Limb Respectively', 'orgStudyIdInfo': {'id': 'Muscular Agenesis Thin plantar'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Agenesis Group', 'description': 'Subjects with the presence of muscular agenesis of the plantar muscle and palmaris longus.', 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'label': 'Non-agenesis Group', 'description': 'Subjects without the presence of muscular agenesis of the plantar muscle and palmaris longus.', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'An ultrasound examination of the musculature of the plantar muscle and long palmar muscle is performed to determine their presence or absence.', 'armGroupLabels': ['Agenesis Group', 'Non-agenesis Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28804', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Alvaro Garcia-Luna, MSc', 'role': 'CONTACT', 'email': 'alvaro.garci@edu.uah.es', 'phone': '+34646777034'}], 'facility': 'Campus Científico-Tecnológico UAH. Av. de León, 3A, Alcalá de Henares, Madrid', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}], 'centralContacts': [{'name': 'Alvaro Garcia-Luna, MSc', 'role': 'CONTACT', 'email': 'alvaro.garci@edu.uah.es', 'phone': '+34646777034'}, {'name': 'Jose-Jesus Jimenez-Rejano, PhD', 'role': 'CONTACT', 'email': 'jjjimenez@us.es', 'phone': '+34667309369'}], 'overallOfficials': [{'name': 'Alvaro Garcia-Luna, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alcala'}, {'name': 'Jose-Jesus Jimenez-Rejano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Seville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'JJ JIMENEZ-REJANO', 'investigatorAffiliation': 'University of Seville'}}}}