NCT05399472

Brief 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.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 25, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

May 26, 2022

Last Update Submit

June 6, 2022

Conditions

Keywords

Functional hallux limitusAnkle dorsiflexion

Outcome Measures

Primary Outcomes (2)

  • Dorsiflexion Lunge Test

    Measurement in centimeters taken from the heel of the examined leg to the wall.

    T1: first day

  • 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

Study Arms (1)

Participant

The participants must be teenage basketball players (12-17 years old). The exclusion criteria are: * 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.

Diagnostic Test: Dorsiflexion lunge testDiagnostic Test: Jack Test

Interventions

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.

Participant
Jack TestDIAGNOSTIC_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.

Participant

Eligibility Criteria

Age12 Years - 17 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Male teenager basketball players from Bologna competitive sports clubs.

You may qualify if:

  • male teenages basketball players enrolled in a competitive sports club
  • teenagers whose parents have signed the privacy and consent forms

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di scienze biomediche e Neuromotorie (DIBINEM) - Università di Bologna (MED/48)

Bologna, 40130, Italy

Location

Related Publications (8)

  • 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. doi: 10.7547/87507315-92-5-269.

    PMID: 12015407BACKGROUND
  • 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. doi: 10.7547/0960428.

    PMID: 16988174BACKGROUND
  • 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. doi: 10.7547/1010467.

    PMID: 22106194BACKGROUND
  • Durrant B, Chockalingam N. Functional hallux limitus: a review. J Am Podiatr Med Assoc. 2009 May-Jun;99(3):236-43. doi: 10.7547/0980236.

    PMID: 19448175BACKGROUND
  • 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.

    PMID: 24901585BACKGROUND
  • Sanchez-Gomez R, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Calvo-Lobo C, Navarro-Flores E, Palomo-Lopez P, Romero-Morales C, Lopez-Lopez D. Reliability Study of Diagnostic Tests for Functional Hallux Limitus. Foot Ankle Int. 2020 Apr;41(4):457-462. doi: 10.1177/1071100719901116. Epub 2020 Jan 29.

  • Tregouet 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.

  • 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. doi: 10.7547/0940269.

MeSH Terms

Conditions

Hallux Limitus

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint DiseasesFoot InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Paolo Pillastrini

    Università degli studi di Bologna

    STUDY DIRECTOR
  • Silvia Pozzan

    Università degli studi di Bologna

    PRINCIPAL INVESTIGATOR
  • Tommaso Torriglia

    Università degli studi di Bologna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 1, 2022

Study Start

May 25, 2022

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Locations