Hallux LimitusNCT05399472
Teenage Functional Hallux Limitus and Ankle Dorsiflexion Study
An observational study of Hallux Limitus and Ankle Joint, run by University of Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years, men only
- Conditions the study is for
- Hallux Limitus, Ankle Joint
- What is being tested?
- Dorsiflexion lunge test and Jack Test
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Men only
- No healthy volunteers
- Child
Study population: Male teenager basketball players from Bologna competitive sports clubs.
Who may be able to join
- male teenages basketball players enrolled in a competitive sports club
- teenagers whose parents have signed the privacy and consent forms
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di scienze biomediche e Neuromotorie (DIBINEM) - Università di Bologna (MED/48)
Bologna, 40130
About this study
Official title: 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.
Read the 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.
- Conditions
- Hallux Limitus, Ankle Joint
- Being tested
- Dorsiflexion lunge test, Jack Test
- Keywords
- Functional hallux limitus, Ankle dorsiflexion
- Medical subject headings
- Hallux Limitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsiflexion lunge testDiagnostic 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Dorsiflexion lunge test; Diagnostic Test: Jack Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsiflexion Lunge Test
Measurement in centimeters taken from the heel of the examined leg to the wall.
Measured: 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.
Measured: T1: first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start25 May 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hallux LimitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ballardin Francesco, University of Bologna
- Investigators
- Paolo Pillastrini, Study director, Università degli studi di BolognaSilvia Pozzan, Principal investigator, Università degli studi di BolognaTommaso Torriglia, Study chair, Università degli studi di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399472
- Sponsor's protocol ID
- TMUNIBO2022PS
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be sharing by a publication and will be stored and shared with those who request it while maintaining the anonymity of participants.
Publications
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.
PubMed 12015407Van 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.
PubMed 16988174Lafuente 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.
PubMed 22106194Durrant B, Chockalingam N. Functional hallux limitus: a review. J Am Podiatr Med Assoc. 2009 May-Jun;99(3):236-43. doi: 10.7547/0980236.
PubMed 19448175Aranda 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.
PubMed 24901585Sanchez-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.
PubMed 31994419Tregouet 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.
PubMed 25275734Hall 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.
PubMed 15153589
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Interdependence Between Functional Hallux Limitus and Ankle Dorsiflexion in Healthy Adolescent Athletes
- ClinicalTrials.gov ID
- NCT05399472
- Acronym / sponsor ID
- TMUNIBO2022PS
- Conditions
- Hallux Limitus, Ankle Joint
- Keywords
- Functional hallux limitus, Ankle dorsiflexion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | – | Diagnostic Test: Dorsiflexion lunge test, Diagnostic Test: Jack TestThe 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Male teenager basketball players from Bologna competitive sports clubs.
Key inclusion criteria (2 listed)
- male teenages basketball players enrolled in a competitive sports club
- teenagers whose parents have signed the privacy and consent forms
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsiflexion lunge testThe 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 | Participant |
| Jack TestThe 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. | Diagnostic test | Participant |
Primary outcome
Dorsiflexion Lunge Test
Time frame: T1: first day
Measurement in centimeters taken from the heel of the examined leg to the wall.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Background: PubMed 12015407Payne 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.
- Background: PubMed 16988174Van 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.
- Background: PubMed 22106194Lafuente 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.
- Background: PubMed 19448175Durrant B, Chockalingam N. Functional hallux limitus: a review. J Am Podiatr Med Assoc. 2009 May-Jun;99(3):236-43. doi: 10.7547/0980236.
- Background: PubMed 24901585Aranda 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.
- Results publication: PubMed 31994419Sanchez-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.
- Results publication: PubMed 25275734Tregouet 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.
- Results publication: PubMed 15153589Hall 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.
- Individual participant dataSharing planned: Undecided. IPD will be sharing by a publication and will be stored and shared with those who request it while maintaining the anonymity of participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Pillastrini study director
Università degli studi di Bologna
Silvia Pozzan principal investigator
Università degli studi di Bologna
Tommaso Torriglia study chair
Università degli studi di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Limitus and Ankle Joint, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dorsiflexion Lunge Test (time frame: T1: first day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399472, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.