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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05399472
Other study ID # TMUNIBO2022PS
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 25, 2022
Est. completion date July 31, 2022

Study information

Verified date June 2022
Source University of Bologna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to identify a possible correlation between reduced mobility of the first toe under load and reduced mobility of the ankle ROM in healthy adolescent basketball players. To reach this goal, two non-invasive tests will be performed to measure the amount of movement of the ankle joint and the first toe.


Description:

Functional hallux limitus (FHL) is a common condition of the first metatarsophalangeal joint (MTF) characterized by reduced dorsiflexion (DF) under load and has a negative effect on load transfer during toe off. This condition is especially common among athletes, even at a youth age, due to repeated loads that can lead to tissue and/or joint damage. The compensations that occur in athletes with an FHL can negatively affect sports performance and start injuries. Limited ankle dorsiflexion under load is another element that can affect sports performance as well as predisposing to injury. Several studies have investigated its regional interdependence but only a few have hypothesized a correlation between this limitation and FHL. The aim of this study is to understand a possible correlation between reduced ankle DF and reduced MTF dorsiflexion during loading, so that preventive action can be taken to reduce the risk of injury. Participants will fill in a cross-check survey to establish if there are any predisposing factors for FHL or ankle DF reduction. The dorsiflexion lunge test (DLT) will be used to measure ankle dorsiflexion. The Jack Test will be used to measure first toe dorsiflexion under load and the Dorsiflexion Lunge Test will be used to measure ankle DF.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date July 31, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Male
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria: - male teenages basketball players enrolled in a competitive sports club - teenagers whose parents have signed the privacy and consent forms Exclusion Criteria: - athletes who have suffered in the last 3 months of lower limb musculoskeletal disorders such as pain for more than 7 days (ankle distortion outcomes, leg/foot fractures, plantar fasciopathy, metatarsalgias, etc); - athletes who have undergone surgery on their lower limb.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Dorsiflexion lunge test
The dorsiflexion lunge test (DLT) will be used to measure ankle dorsiflexion. To perform this test, the participant stands in front of a wall holding the foot of their limb to be measured perpendicularly to it. The other foot is to be kept behind it. The participant is asked to perform a lunge (to dorsiflex the ankle and bring the knee into flexion) until the front knee touches the wall without the heel lifting off the ground. The participant steps away from the wall as much as possible as long as the knee keeps touching the wall. Measurement in centimeters is taken from the heel of the examined leg to the wall.
Jack Test
The Jack Test will be used to measure the first toe dorsiflexion under load. The examiner pulled the proximal phalanx of the hallux to dorsiflexion with his hand until the maximal amount of mobility was reached with the subject standing. The static arm of the goniometer was placed along the first metatarsal longitudinal axis while the free movable arm followed the proximal phalanx of the hallux axes.

Locations

Country Name City State
Italy Dipartimento di scienze biomediche e Neuromotorie (DIBINEM) - Università di Bologna (MED/48) Bologna

Sponsors (1)

Lead Sponsor Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Aranda Y, Munuera PV. Plantar fasciitis and its relationship with hallux limitus. J Am Podiatr Med Assoc. 2014 May;104(3):263-8. doi: 10.7547/0003-0538-104.3.263. — View Citation

Durrant B, Chockalingam N. Functional hallux limitus: a review. J Am Podiatr Med Assoc. 2009 May-Jun;99(3):236-43. Review. — View Citation

Hall C, Nester CJ. Sagittal plane compensations for artificially induced limitation of the first metatarsophalangeal joint: a preliminary study. J Am Podiatr Med Assoc. 2004 May-Jun;94(3):269-74. — View Citation

Lafuente G, Munuera PV, Dominguez G, Reina M, Lafuente B. Hallux limitus and its relationship with the internal rotational pattern of the lower limb. J Am Podiatr Med Assoc. 2011 Nov-Dec;101(6):467-74. — View Citation

Payne C, Chuter V, Miller K. Sensitivity and specificity of the functional hallux limitus test to predict foot function. J Am Podiatr Med Assoc. 2002 May;92(5):269-71. — View Citation

Sánchez-Gómez R, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Calvo-Lobo C, Navarro-Flores E, Palomo-López P, Romero-Morales C, López-López D. Reliability Study of Diagnostic Tests for Functional Hallux Limitus. Foot Ankle Int. 2020 Apr;41(4):457-462. d — View Citation

Trégouët P. An assessment of hallux limitus in university basketball players compared with noncompetitive individuals. J Am Podiatr Med Assoc. 2014 Sep-Oct;104(5):468-72. doi: 10.7547/0003-0538-104.5.468. — View Citation

Van Gheluwe B, Dananberg HJ, Hagman F, Vanstaen K. Effects of hallux limitus on plantar foot pressure and foot kinematics during walking. J Am Podiatr Med Assoc. 2006 Sep-Oct;96(5):428-36. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dorsiflexion Lunge Test Measurement in centimeters taken from the heel of the examined leg to the wall. T1: first day
Primary Jack test Degrees of movement will be measured with a goniometer. Static arm of the goniometer was placed along the first metatarsal longitudinal axis while the free movable arm followed the proximal phalanx of the hallux axes. T1: first day
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