Ankle JointNCT05403892
Reliability and Validity of a New Ankle Dorsiflexion Lunge Test Using a Level Laser.
An observational study of Ankle Joint and Range of Motion, Articular, run by University of Bologna at 1 site in Italy.
Trial summary
The study aims to find validity and intra-inter examiner reliability of the Lever Laser Lunge Test (LLLT). This is a new way to measure ankle range of motion during weight bearing, instead of classical dorsiflexion lunge test The study wants to assume that LLLT is comparable to the traditional test but more efficient… Read more about this study
- Who is it for?
- Ages 12 to 17 years, men only
- Conditions the study is for
- Ankle Joint, Range of Motion, Articular, Reliability and Validity
- What is being tested?
- level laser lunge test and dorsiflexion Lunge test
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 28 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 teenagers basketball players from Bologna competitive sports clubs.
Who may be able to join
- male teenagers 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 heel pain, metatarsalgias, etc);
- athletes who have undergone surgery on their lower limb.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento di Scienze Biomediche e Neuromotorie (DIBINEM)
Bologna, 40138
Pillastrini Paolo, +39/0512142496, paolo.pillastrini@unibo.it
About this study
Official title: Inter and Intra-observer Reliability and Validity of the Ankle Dorsiflexion Lunge Test With a Level Laser in Healthy Teenage Athletes: a Novel Way of Measuring.
The study aims to find validity and intra-inter examiner reliability of the Lever Laser Lunge Test (LLLT). This is a new way to measure ankle range of motion during weight bearing, instead of classical dorsiflexion lunge test The study wants to assume that LLLT is comparable to the traditional test but more efficient because it could be used in different settings.
To reach this goal, these two non-invasive tests will be performed to measure the amount of movement of the ankle joint in healthy teenage basketball players.
Data will be statistically compared and studied.
Read the detailed description
The dorsiflexion lunge test or knee-to-wall test (DLT) measure the range of movement of weight bearing ankle dorsiflexion. This test is frequently used in sport setting, in order to identify ankle limitations which could lead to possible injuries or joint overloads.
DLT is a cheap and simple measurement method to assess the ankle dorsiflexion, however clinicians find possible bias that reduce the usability of this test.
In order to remove this bias, this study suggests a new measurement method carried out by a level laser to create a virtual wall (the vertical red line produced by the laser).
The study aims therefore to estimate the validity and intra-inter examiner reliability of this method, in comparison to the DLT.
The instruments used are a professional level laser and a rigid ruler. A group of male teenager basketball players from Bologna competitive sports clubs will be recruited.
In order to assess the validity of this new test the clinicians will compare statistically the outcome of both test In order to assess the intra and inter examiner reliability the clinicians will compare repeated measurements of the LLLT.
It is assumed that both measurement methods (traditional and laser method) have comparable validity but LLLT reliability intra and inter examiner should be higher than the DLT one.
- Being tested
- level laser lunge test, dorsiflexion Lunge test
- Keywords
- level laser, dorsiflexion lunge test, ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level laser lunge testDiagnostic test
In order to perform the Level Laser Test, the operator 1 places a laser lever on the ground one metre aside and 50 cm forward the ankle to be examined. This laser (a 2-class laser not harmful to the eyes) maintains a linear laser light beam perpendicular to the floor. The examined leg is placed further forward to the other one, as it happens in the DLT. The teenage performs a forward lunge perpendicularly to the laser line, the heel positioning 50 cm from the laser line. Operator 1 has the subject perform a lunge while operator 2 measures the distance from the kneecap to the laser line. The measurement, deducted by 50 cm, leads to the heel-to-wall distance (value used to DLT).
dorsiflexion Lunge testDiagnostic test
Also called weight bearing lunge test
The dorsiflexion lunge test (DLT) will be used to measure ankle dorsiflexion. To perform this test, the teenage 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 teenage 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 teenage 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.
| 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 heel pain, metatarsalgias, etc);
* athletes who have undergone surgery on their lower limb. Receives: Diagnostic Test: level laser lunge test; Diagnostic Test: dorsiflexion Lunge test |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of lever laser lunge test
the collected values will be statistically processed to identify a significant validity of the LLLT comparing to the DLT
Measured: 1 day
intra-examiner reliability of lever laser lunge test
the collected values will be statistically processed to identify a significant intra-examiner reliability of the LLLT compared to the DLT values found in the bibliography
Measured: 2 days
inter-examiner reliability of lever laser lunge test
the collected values will be statistically processed to identify a significant inter-examiner reliability of the LLLT compared to the DLT values found in the bibliography
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start28 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 (10)Papers the sponsor has linked to this study.
- Other trials for Ankle JointStudies 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
- Tommaso Torriglia, Principal investigator, Università degli studi di BolognaPillastrini Paolo, Study director, Università degli studi di BolognaSilvia Pozzan, Study chair, Università degli studi di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403892
- Sponsor's protocol ID
- TMUNIBO2022TT
- Status last verified
- Jun 2022
- First submitted
- 31 May 2022
- Last updated
- 13 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
Hall EA, Docherty CL. Validity of clinical outcome measures to evaluate ankle range of motion during the weight-bearing lunge test. J Sci Med Sport. 2017 Jul;20(7):618-621. doi: 10.1016/j.jsams.2016.11.001. Epub 2016 Nov 23.
PubMed 28108266Kang MH, Oh JS. Relationship Between Weightbearing Ankle Dorsiflexion Passive Range of Motion and Ankle Kinematics During Gait. J Am Podiatr Med Assoc. 2017 Jan;107(1):39-45. doi: 10.7547/14-112.
PubMed 28271931Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.
PubMed 22666642Munteanu SE, Strawhorn AB, Landorf KB, Bird AR, Murley GS. A weightbearing technique for the measurement of ankle joint dorsiflexion with the knee extended is reliable. J Sci Med Sport. 2009 Jan;12(1):54-9. doi: 10.1016/j.jsams.2007.06.009. Epub 2007 Sep 20.
PubMed 17888733Rose KJ, Burns J, North KN. Factors associated with foot and ankle strength in healthy preschool-age children and age-matched cases of Charcot-Marie-Tooth disease type 1A. J Child Neurol. 2010 Apr;25(4):463-8. doi: 10.1177/0883073809340698. Epub 2009 Aug 11.
PubMed 19671887Bennell KL, Talbot RC, Wajswelner H, Techovanich W, Kelly DH, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44(3):175-180. doi: 10.1016/s0004-9514(14)60377-9.
PubMed 11676731Cejudo A, Sainz de Baranda P, Ayala F, Santonja F. A simplified version of the weight-bearing ankle lunge test: description and test-retest reliability. Man Ther. 2014 Aug;19(4):355-9. doi: 10.1016/j.math.2014.03.008. Epub 2014 Apr 2.
PubMed 24746162Gatt A, Chockalingam N. Clinical assessment of ankle joint dorsiflexion: a review of measurement techniques. J Am Podiatr Med Assoc. 2011 Jan-Feb;101(1):59-69. doi: 10.7547/1010059.
PubMed 21242472Langarika-Rocafort A, Emparanza JI, Aramendi JF, Castellano J, Calleja-Gonzalez J. Intra-rater reliability and agreement of various methods of measurement to assess dorsiflexion in the Weight Bearing Dorsiflexion Lunge Test (WBLT) among female athletes. Phys Ther Sport. 2017 Jan;23:37-44. doi: 10.1016/j.ptsp.2016.06.010. Epub 2016 Jun 29.
PubMed 27665249Powden CJ, Hoch JM, Hoch MC. Reliability and minimal detectable change of the weight-bearing lunge test: A systematic review. Man Ther. 2015 Aug;20(4):524-32. doi: 10.1016/j.math.2015.01.004. Epub 2015 Jan 29.
PubMed 25704110
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter and Intra-observer Reliability and Validity of the Ankle Dorsiflexion Lunge Test With a Level Laser in Healthy Teenage Athletes: a Novel Way of Measuring.
- ClinicalTrials.gov ID
- NCT05403892
- Acronym / sponsor ID
- TMUNIBO2022TT
- Keywords
- level laser, dorsiflexion lunge test, ankle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 28 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 3 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.
The study aims to find validity and intra-inter examiner reliability of the Lever Laser Lunge Test (LLLT). This is a new way to measure ankle range of motion during weight bearing, instead of classical dorsiflexion lunge test The study wants to assume that LLLT is comparable to the traditional test but more efficient because it could be used in different settings.
To reach this goal, these two non-invasive tests will be performed to measure the amount of movement of the ankle joint in healthy teenage basketball players.
Data will be statistically compared and studied.
Detailed description
The dorsiflexion lunge test or knee-to-wall test (DLT) measure the range of movement of weight bearing ankle dorsiflexion. This test is frequently used in sport setting, in order to identify ankle limitations which could lead to possible injuries or joint overloads.
DLT is a cheap and simple measurement method to assess the ankle dorsiflexion, however clinicians find possible bias that reduce the usability of this test.
In order to remove this bias, this study suggests a new measurement method carried out by a level laser to create a virtual wall (the vertical red line produced by the laser).
The study aims therefore to estimate the validity and intra-inter examiner reliability of this method, in comparison to the DLT.
The instruments used are a professional level laser and a rigid ruler. A group of male teenager basketball players from Bologna competitive sports clubs will be recruited.
In order to assess the validity of this new test the clinicians will compare statistically the outcome of both test In order to assess the intra and inter examiner reliability the clinicians will compare repeated measurements of the LLLT.
It is assumed that both measurement methods (traditional and laser method) have comparable validity but LLLT reliability intra and inter examiner should be higher than the DLT one.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | – | Diagnostic Test: level laser lunge test, Diagnostic Test: dorsiflexion Lunge 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 heel pain, 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 teenagers basketball players from Bologna competitive sports clubs.
Key inclusion criteria (2 listed)
- male teenagers 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 heel pain, 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 |
|---|---|---|
| level laser lunge testIn order to perform the Level Laser Test, the operator 1 places a laser lever on the ground one metre aside and 50 cm forward the ankle to be examined. This laser (a 2-class laser not harmful to the eyes) maintains a linear laser light beam perpendicular to the floor. The examined leg is placed further forward to the other one, as it happens in the DLT. The teenage performs a forward lunge perpendicularly to the laser line, the heel positioning 50 cm from the laser line. Operator 1 has the subject perform a lunge while operator 2 measures the distance from the kneecap to the laser line. The measurement, deducted by 50 cm, leads to the heel-to-wall distance (value used to DLT). | Diagnostic test | Participant |
| dorsiflexion Lunge testAlso: weight bearing lunge testThe dorsiflexion lunge test (DLT) will be used to measure ankle dorsiflexion. To perform this test, the teenage 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 teenage 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 teenage 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 |
Primary outcome
validity of lever laser lunge test
Time frame: 1 day
the collected values will be statistically processed to identify a significant validity of the LLLT comparing to the DLT
intra-examiner reliability of lever laser lunge test
Time frame: 2 days
the collected values will be statistically processed to identify a significant intra-examiner reliability of the LLLT compared to the DLT values found in the bibliography
inter-examiner reliability of lever laser lunge test
Time frame: 2 days
the collected values will be statistically processed to identify a significant inter-examiner reliability of the LLLT compared to the DLT values found in the bibliography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Background: PubMed 28108266Hall EA, Docherty CL. Validity of clinical outcome measures to evaluate ankle range of motion during the weight-bearing lunge test. J Sci Med Sport. 2017 Jul;20(7):618-621. doi: 10.1016/j.jsams.2016.11.001. Epub 2016 Nov 23.
- Background: PubMed 28271931Kang MH, Oh JS. Relationship Between Weightbearing Ankle Dorsiflexion Passive Range of Motion and Ankle Kinematics During Gait. J Am Podiatr Med Assoc. 2017 Jan;107(1):39-45. doi: 10.7547/14-112.
- Background: PubMed 22666642Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.
- Background: PubMed 17888733Munteanu SE, Strawhorn AB, Landorf KB, Bird AR, Murley GS. A weightbearing technique for the measurement of ankle joint dorsiflexion with the knee extended is reliable. J Sci Med Sport. 2009 Jan;12(1):54-9. doi: 10.1016/j.jsams.2007.06.009. Epub 2007 Sep 20.
- Background: PubMed 19671887Rose KJ, Burns J, North KN. Factors associated with foot and ankle strength in healthy preschool-age children and age-matched cases of Charcot-Marie-Tooth disease type 1A. J Child Neurol. 2010 Apr;25(4):463-8. doi: 10.1177/0883073809340698. Epub 2009 Aug 11.
- Results publication: PubMed 11676731Bennell KL, Talbot RC, Wajswelner H, Techovanich W, Kelly DH, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44(3):175-180. doi: 10.1016/s0004-9514(14)60377-9.
- Results publication: PubMed 24746162Cejudo A, Sainz de Baranda P, Ayala F, Santonja F. A simplified version of the weight-bearing ankle lunge test: description and test-retest reliability. Man Ther. 2014 Aug;19(4):355-9. doi: 10.1016/j.math.2014.03.008. Epub 2014 Apr 2.
- Results publication: PubMed 21242472Gatt A, Chockalingam N. Clinical assessment of ankle joint dorsiflexion: a review of measurement techniques. J Am Podiatr Med Assoc. 2011 Jan-Feb;101(1):59-69. doi: 10.7547/1010059.
- Results publication: PubMed 27665249Langarika-Rocafort A, Emparanza JI, Aramendi JF, Castellano J, Calleja-Gonzalez J. Intra-rater reliability and agreement of various methods of measurement to assess dorsiflexion in the Weight Bearing Dorsiflexion Lunge Test (WBLT) among female athletes. Phys Ther Sport. 2017 Jan;23:37-44. doi: 10.1016/j.ptsp.2016.06.010. Epub 2016 Jun 29.
- Results publication: PubMed 25704110Powden CJ, Hoch JM, Hoch MC. Reliability and minimal detectable change of the weight-bearing lunge test: A systematic review. Man Ther. 2015 Aug;20(4):524-32. doi: 10.1016/j.math.2015.01.004. Epub 2015 Jan 29.
- A study to determine the reliability of an ankle dorsiflexion weight-bearing deviceLink provided by the sponsor.
- 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.
Tommaso Torriglia principal investigator
Università degli studi di Bologna
Pillastrini Paolo study director
Università degli studi di Bologna
Silvia Pozzan 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 Ankle Joint and Range of Motion, Articular, 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 13 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?
Contact Carla Vanti (+39/335475464, carla.vanti@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of lever laser lunge test (time frame: 1 day). The study lists 3 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 NCT05403892, which also lists 10 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 13 Jun 2022.