Teenage Functional Hallux Limitus and Ankle Dorsiflexion Study

June 6, 2022 updated by: Ballardin Francesco, University of Bologna

Regional Interdependence Between Functional Hallux Limitus and Ankle Dorsiflexion in Healthy Adolescent Athletes

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40130
        • Dipartimento di scienze biomediche e Neuromotorie (DIBINEM) - Università di Bologna (MED/48)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male teenager basketball players from Bologna competitive sports clubs.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dorsiflexion Lunge Test
Time Frame: T1: first day
Measurement in centimeters taken from the heel of the examined leg to the wall.
T1: first day
Jack test
Time Frame: T1: first day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Study Director: Paolo Pillastrini, Università degli studi di Bologna
  • Principal Investigator: Silvia Pozzan, Università degli studi di Bologna
  • Study Chair: Tommaso Torriglia, Università degli studi di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMUNIBO2022PS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD will be sharing by a publication and will be stored and shared with those who request it while maintaining the anonymity of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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