NCT04103437

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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

November 3, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
Last Updated

February 24, 2021

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

November 27, 2018

Last Update Submit

February 23, 2021

Conditions

Keywords

running harmonicityrunning related injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation between running gait harmonicity and spatio-temporal running parameters

    1 year

  • Correlation between running gait harmonicity and metabolic parameters

    1 year

  • Correlation between running related injuries (RRI) and running gait harmonicity

    1 year

Study Arms (1)

recreational runners

Recreational runners (minimum of 2 running session and 20km of total mileage per week), with seasonal best on half-marathon comprised between 1h20' and 2h00'. Age \> 18 and \< 60 years. Free from musculoskeletal injuries from at least three months.

Diagnostic Test: Maximal incremental running testDiagnostic Test: Metabolic and movement analysis of runningOther: Questionnaires

Interventions

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

recreational runners

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

recreational runners

Monthly follow-up questionnaire (12 months) about training habits and injuries

recreational runners

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

recreational runners

You may qualify if:

  • 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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Don Carlo Gnocchi

Florence, Tuscany, 50100, Italy

Location

Related Publications (15)

  • Huijben B, van Schooten KS, van Dieen 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.

    PMID: 30558916BACKGROUND
  • 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.

  • 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: 10.1177/0363546509347985. Epub 2009 Dec 4.

  • Videbaek 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.

  • 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. doi: 10.1136/bjsm.2006.033548. Epub 2007 May 1.

  • 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. doi: 10.1016/j.pmr.2005.02.002.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Iosa M, Bini F, Marinozzi F, Fusco A, Morone G, Koch G, Martino Cinnera A, Bonni S, Paolucci S. Stability and Harmony of Gait in Patients with Subacute Stroke. J Med Biol Eng. 2016;36(5):635-643. doi: 10.1007/s40846-016-0178-0. Epub 2016 Oct 7.

  • 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.

  • 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. doi: 10.1177/0363546506288753. Epub 2006 May 30.

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Metabolic Networks and PathwaysSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

MetabolismData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Guido Pasquini, Bs

    IRCCS Fondazione Don Carlo Gnocchi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2018

First Posted

September 25, 2019

Study Start

November 3, 2018

Primary Completion

October 3, 2019

Study Completion

December 3, 2019

Last Updated

February 24, 2021

Record last verified: 2018-10

Locations