NCT05403892

Brief 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 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.

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 28, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
27 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 13, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

May 31, 2022

Last Update Submit

June 8, 2022

Conditions

Keywords

level laserdorsiflexion lunge testankle

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    2 days

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 heel pain, metatarsalgias, etc); * athletes who have undergone surgery on their lower limb.

Diagnostic Test: level laser lunge testDiagnostic Test: dorsiflexion Lunge test

Interventions

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).

Participant

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.

Also known as: weight bearing lunge test
Participant

Eligibility Criteria

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

Male teenagers basketball players from Bologna competitive sports clubs.

You may qualify if:

  • male teenagers 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 heel pain, 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)

Bologna, 40138, Italy

RECRUITING

Related Publications (10)

  • 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.

    PMID: 28108266BACKGROUND
  • Kang 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.

    PMID: 28271931BACKGROUND
  • Konor 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.

    PMID: 22666642BACKGROUND
  • Munteanu 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.

    PMID: 17888733BACKGROUND
  • Rose 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.

    PMID: 19671887BACKGROUND
  • Bennell 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.

  • Cejudo 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.

  • Gatt 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.

  • Langarika-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.

  • Powden 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.

Related Links

Study Officials

  • Tommaso Torriglia

    Università degli studi di Bologna

    PRINCIPAL INVESTIGATOR
  • Pillastrini Paolo

    Università degli studi di Bologna

    STUDY DIRECTOR
  • Silvia Pozzan

    Università degli studi di Bologna

    STUDY CHAIR

Central Study Contacts

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 31, 2022

First Posted

June 3, 2022

Study Start

May 28, 2022

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06

Locations