NCT06448832

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 3, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

muscle agenesisthin plantarforceinjuriesmusculoskeletal palmar longperformance

Outcome Measures

Primary Outcomes (1)

  • Presence of injury

    Presence of injury related to the upper and lower limb.

    At the start of the study (at baseline, 0 week).

Secondary Outcomes (1)

  • Strength

    At the start of the study (at baseline, 0 week)

Study Arms (2)

Agenesis Group

Subjects with the presence of muscular agenesis of the plantar muscle and palmaris longus.

Diagnostic Test: Ultrasound

Non-agenesis Group

Subjects without the presence of muscular agenesis of the plantar muscle and palmaris longus.

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

An ultrasound examination of the musculature of the plantar muscle and long palmar muscle is performed to determine their presence or absence.

Agenesis GroupNon-agenesis Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with and without muscle agenesis.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Científico-Tecnológico UAH. Av. de León, 3A, Alcalá de Henares, Madrid

Alcalá de Henares, Madrid, 28804, Spain

Location

Related Publications (11)

  • 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: 25555023BACKGROUND
  • 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: 26491493BACKGROUND
  • 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: 29791956BACKGROUND
  • 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: 20486022BACKGROUND
  • 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: 21107568BACKGROUND
  • 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: 30150961BACKGROUND
  • 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: 27682306BACKGROUND
  • 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: 22801514BACKGROUND
  • 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: 29071305BACKGROUND
  • 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: 18503813BACKGROUND
  • 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.

    PMID: 19661831BACKGROUND

MeSH Terms

Conditions

Congenital AbnormalitiesWounds and Injuries

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alvaro Garcia-Luna, MSc

    University of Alcala

    PRINCIPAL INVESTIGATOR
  • Jose-Jesus Jimenez-Rejano, PhD

    University of Seville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro Garcia-Luna, MSc

CONTACT

Jose-Jesus Jimenez-Rejano, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations