- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06448832
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 (MA-TP-PL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Objectives. To determine if muscle agenesis influences the development of injuries and its impact on strength and performance.
Material 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alvaro Garcia-Luna, MSc
- Phone Number: +34646777034
- Email: alvaro.garci@edu.uah.es
Study Contact Backup
- Name: Jose-Jesus Jimenez-Rejano, PhD
- Phone Number: +34667309369
- Email: jjjimenez@us.es
Study Locations
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-
Madrid
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Alcalá De Henares, Madrid, Spain, 28804
- Campus Científico-Tecnológico UAH. Av. de León, 3A, Alcalá de Henares, Madrid
-
Contact:
- Alvaro Garcia-Luna, MSc
- Phone Number: +34646777034
- Email: alvaro.garci@edu.uah.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals who lead a sedentary lifestyle or who are not used to doing physical training on a regular basis (more than 2 h/week).
- People between 18 and 80 years old.
Exclusion Criteria:
- Individuals with an ongoing oncological process.
- People with an active infectious process.
- Subjects with psychiatric disorders.
- Individuals with intellectual disorders that prevent understanding of the intervention.
- People with judicial incapacity.
- Patients diagnosed with fibromyalgia.
- Pregnancy or probability of pregnancy.
- Individuals with sensory impairments in the hand that prevent manual pressure.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Agenesis Group
Subjects with the presence of muscular agenesis of the plantar muscle and palmaris longus.
|
An ultrasound examination of the musculature of the plantar muscle and long palmar muscle is performed to determine their presence or absence.
|
|
Non-agenesis Group
Subjects without the presence of muscular agenesis of the plantar muscle and palmaris longus.
|
An ultrasound examination of the musculature of the plantar muscle and long palmar muscle is performed to determine their presence or absence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of injury
Time Frame: At the start of the study (at baseline, 0 week).
|
Presence of injury related to the upper and lower limb.
|
At the start of the study (at baseline, 0 week).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: At the start of the study (at baseline, 0 week)
|
Upper and lower limb strength
|
At the start of the study (at baseline, 0 week)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alvaro Garcia-Luna, MSc, University of Alcala
- Principal Investigator: Jose-Jesus Jimenez-Rejano, PhD, University of Seville
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: J Clin Med Res. 2016 Jan;8(1):62.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Arch Phys Med Rehabil. 2008 Aug;89(8):1628. Wrigley Tim W [corrected to Wrigley, Tim V].
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Muscular Agenesis Thin plantar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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