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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04103437
Other study ID # harmrun fdg
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 3, 2018
Est. completion date December 3, 2019

Study information

Verified date October 2018
Source Fondazione Don Carlo Gnocchi Onlus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to demonstrate the use of a digital video analysis method to evaluate harmonicity of running gait, through an holistic approach. Furthermore, it explores the association of running gait harmonicity with running velocity and level of training and with running injuries risk .


Description:

Aetiology of running related injuries is reported to be multifactorial but still not fully understood. Factors that impede the understanding of the mechanisms and aetiology of injury are the traditional segmental approach to the analysis of running gait and the lack of prospective studies. A more holistic approach to analysis of movement could permit a more in depth comprehension of the injured state, trough a changing of point of view. This holistic approach is based on the harmonic nature of running gait. Despite the everyday use of the term "harmonicity" within sporting domains, methods to measure running gait harmonicity is a theme still vaguely explored. Traditional methods evaluate the movement quality of the whole body based on the motion analysis of specific segments, that are supposed to sufficiently represent the entire body. The search for a method to analyse harmonicity of cyclic movements with a real holistic approach, is therefore still open. With these aims, an innovative video analysis method has been proposed, based on the measure of the frequency variation of the pixel brightness in the digital video of a cyclic movement.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date December 3, 2019
Est. primary completion date October 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - at least one year of running practice - minimum two day of running/week - minimum 20 km running/week - seasonal best on half marathon comprised between 1h20' and 2h00' - experienced in treadmill running practice - sport medical certificate Exclusion Criteria: - have suffered in the last three months of musculoskeletal disease - regular practice of sport activities different from running - acute or chronic osteoarticular diseases or, in general, other pathology limiting physical activities - use of drugs altering physical activity performance (hypnotic, psychoactive, non-steroidal anti-inflammatory drugs e.g.).

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Maximal incremental running test
Maximal incremental running test with measures of metabolic, spatio-temporal parameters and video recording with camera in the frontal plane. video recording of frontal view, metabolic and spatio-temporal measures of three (self-selected speed, + and - 20 percentage of self-selected speed) 6 minutes running test monthly (12 months) follow-up questionnaire
Metabolic and movement analysis of running
Running analysis of three six minutes running test (self-selected speed, + and - 20% of the self-selected speed) by video recording with camera in the frontal plane, and acquisition of the metabolic and spatio-temporal parameters
Other:
Questionnaires
Monthly follow-up questionnaire (12 months) about training habits and injuries

Locations

Country Name City State
Italy IRCCS Don Carlo Gnocchi Florence Tuscany

Sponsors (3)

Lead Sponsor Collaborator
Fondazione Don Carlo Gnocchi Onlus Microgate Srl, Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (15)

Bellanca JL, Lowry KA, Vanswearingen JM, Brach JS, Redfern MS. Harmonic ratios: a quantification of step to step symmetry. J Biomech. 2013 Feb 22;46(4):828-31. doi: 10.1016/j.jbiomech.2012.12.008. Epub 2013 Jan 12. — View Citation

Bredeweg SW, Kluitenberg B, Bessem B, Buist I. Differences in kinetic variables between injured and noninjured novice runners: a prospective cohort study. J Sci Med Sport. 2013 May;16(3):205-10. doi: 10.1016/j.jsams.2012.08.002. Epub 2012 Aug 24. — View Citation

Buist I, Bredeweg SW, Lemmink KA, van Mechelen W, Diercks RL. Predictors of running-related injuries in novice runners enrolled in a systematic training program: a prospective cohort study. Am J Sports Med. 2010 Feb;38(2):273-80. doi: 10.1177/036354650934 — View Citation

Hamill J, Palmer C, Van Emmerik RE. Coordinative variability and overuse injury. Sports Med Arthrosc Rehabil Ther Technol. 2012 Nov 27;4(1):45. doi: 10.1186/1758-2555-4-45. — View Citation

Hreljac A. Etiology, prevention, and early intervention of overuse injuries in runners: a biomechanical perspective. Phys Med Rehabil Clin N Am. 2005 Aug;16(3):651-67, vi. Review. — View Citation

Huijben B, van Schooten KS, van Dieën JH, Pijnappels M. The effect of walking speed on quality of gait in older adults. Gait Posture. 2018 Sep;65:112-116. doi: 10.1016/j.gaitpost.2018.07.004. Epub 2018 Jul 10. — View Citation

Iosa M, Bini F, Marinozzi F, Fusco A, Morone G, Koch G, Martino Cinnera A, Bonnì S, Paolucci S. Stability and Harmony of Gait in Patients with Subacute Stroke. J Med Biol Eng. 2016;36(5):635-643. Epub 2016 Oct 7. — View Citation

Kiely J, Collins DJ. Uniqueness of Human Running Coordination: The Integration of Modern and Ancient Evolutionary Innovations. Front Psychol. 2016 Apr 11;7:262. doi: 10.3389/fpsyg.2016.00262. eCollection 2016. Review. — View Citation

Lindsay TR, Yaggie JA, McGregor SJ. Contributions of lower extremity kinematics to trunk accelerations during moderate treadmill running. J Neuroeng Rehabil. 2014 Dec 12;11:162. doi: 10.1186/1743-0003-11-162. — View Citation

Stefanyshyn DJ, Stergiou P, Lun VM, Meeuwisse WH, Worobets JT. Knee angular impulse as a predictor of patellofemoral pain in runners. Am J Sports Med. 2006 Nov;34(11):1844-51. Epub 2006 May 30. — View Citation

Teng HL, Powers CM. Sagittal plane trunk posture influences patellofemoral joint stress during running. J Orthop Sports Phys Ther. 2014 Oct;44(10):785-92. doi: 10.2519/jospt.2014.5249. Epub 2014 Aug 25. — View Citation

Valenzuela KA, Lynn SK, Mikelson LR, Noffal GJ, Judelson DA. Effect of Acute Alterations in Foot Strike Patterns during Running on Sagittal Plane Lower Limb Kinematics and Kinetics. J Sports Sci Med. 2015 Mar 1;14(1):225-32. eCollection 2015 Mar. — View Citation

van Gent RN, Siem D, van Middelkoop M, van Os AG, Bierma-Zeinstra SM, Koes BW. Incidence and determinants of lower extremity running injuries in long distance runners: a systematic review. Br J Sports Med. 2007 Aug;41(8):469-80; discussion 480. Epub 2007 — View Citation

Vannatta CN, Kernozek TW. Patellofemoral joint stress during running with alterations in foot strike pattern. Med Sci Sports Exerc. 2015 May;47(5):1001-8. doi: 10.1249/MSS.0000000000000503. — View Citation

Videbæk S, Bueno AM, Nielsen RO, Rasmussen S. Incidence of Running-Related Injuries Per 1000 h of running in Different Types of Runners: A Systematic Review and Meta-Analysis. Sports Med. 2015 Jul;45(7):1017-26. doi: 10.1007/s40279-015-0333-8. Review. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between running related injuries (RRI) and running gait harmonicity Verify if RRI risk is correlated with measures of harmonicity derived from Graal software (registered during three six minutes running test at low, self-selected, high speed):
• Number of pixel of the nine principal frequencies RRI are registered by follow-up questionnaires each month .
1year
Secondary Correlation between running gait harmonicity and spatio-temporal running parameters The association of running gait harmonicity measures with contact time, flight time, stride length and cadence will be evaluated at each running velocity. 1 year
Secondary Correlation between running gait harmonicity and metabolic parameters The association of running gait harmonicity measures with VO2max, ventilation, respiratory exchange ratio and hearth rate. 1 year
Secondary Correlation between running related injuries (RRI) and running gait harmonicity Verify if RRI risk is correlated with measures of harmonicity derived from Graal software (registered during three six minutes running test at low, self-selected, high speed): Signal/noise ratio (ratio between values of the principal frequencies and noise) 1 year
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