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Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103437
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Microgate Srl
Universita di Verona
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus

Tracking Information
First Submitted Date November 27, 2018
First Posted Date September 25, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date November 3, 2018
Estimated Primary Completion Date October 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2019)
Correlation between running related injuries (RRI) and running gait harmonicity [ Time Frame: 1year ]
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 .
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 24, 2019)
  • Correlation between running gait harmonicity and spatio-temporal running parameters [ Time Frame: 1 year ]
    The association of running gait harmonicity measures with contact time, flight time, stride length and cadence will be evaluated at each running velocity.
  • Correlation between running gait harmonicity and metabolic parameters [ Time Frame: 1 year ]
    The association of running gait harmonicity measures with VO2max, ventilation, respiratory exchange ratio and hearth rate.
  • Correlation between running related injuries (RRI) and running gait harmonicity [ Time Frame: 1 year ]
    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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis
Official Title Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis: Effects on Metabolic Consumption and Running Injuries Risk
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 .

Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population recreational runners
Condition Injuries
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

  • Diagnostic Test: 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
Study Groups/Cohorts 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.
Interventions:
  • Diagnostic Test: Maximal incremental running test
  • Diagnostic Test: Metabolic and movement analysis of running
  • Other: Questionnaires
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Actual Enrollment
 (submitted: September 24, 2019)
112
Original Actual Enrollment Same as current
Estimated Study Completion Date December 3, 2019
Estimated Primary Completion Date October 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04103437
Other Study ID Numbers harmrun fdg
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fondazione Don Carlo Gnocchi Onlus
Study Sponsor Fondazione Don Carlo Gnocchi Onlus
Collaborators
  • Microgate Srl
  • Universita di Verona
Investigators
Principal Investigator: Guido Pasquini, Bs IRCCS Fondazione Don Carlo Gnocchi
PRS Account Fondazione Don Carlo Gnocchi Onlus
Verification Date October 2018