InjuriesNCT04103437
Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis
An observational study of Injuries, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries
- What is being tested?
- Maximal incremental running test, Metabolic and movement analysis of running and Questionnaires
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2018to 3 Dec 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: recreational runners
Who may be able to join
- 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
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
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
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 .
Read the 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.
- Conditions
- Injuries
- Being tested
- Maximal incremental running test, Metabolic and movement analysis of running, Questionnaires
- Keywords
- running harmonicity, running related injuries
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal incremental running testDiagnostic 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 runningDiagnostic test
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
QuestionnairesOther
Monthly follow-up questionnaire (12 months) about training habits and injuries
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Maximal incremental running test; Diagnostic Test: Metabolic and movement analysis of running; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 1year
Secondary outcomes (3)
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.
Measured: 1 year
Correlation between running gait harmonicity and metabolic parameters
The association of running gait harmonicity measures with VO2max, ventilation, respiratory exchange ratio and hearth rate.
Measured: 1 year
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start3 Nov 2018
- Primary completion3 Oct 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Microgate Srl, Universita di Verona
- Responsible party
- Sponsor
- Investigators
- Guido Pasquini, Bs, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103437
- Sponsor's protocol ID
- harmrun fdg
- Status last verified
- Oct 2018
- First submitted
- 27 Nov 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30558916Lindsay 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.
PubMed 25495782Buist 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.
PubMed 19966104Videbaek 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.
PubMed 25951917van 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.
PubMed 17473005Hreljac 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.
PubMed 16005398Vannatta 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.
PubMed 25202853Teng 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.
PubMed 25155651Valenzuela 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.
PubMed 25729311Hamill 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.
PubMed 23186012Kiely 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.
PubMed 27148098Bredeweg 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.
PubMed 22921763Iosa 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.
PubMed 27853414Bellanca 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.
PubMed 23317758Stefanyshyn 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.
PubMed 16735584
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04103437
- Acronym / sponsor ID
- harmrun fdg
- Conditions
- Injuries
- Keywords
- running harmonicity, running related injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Microgate Srl, Universita di Verona
- Study start
- 3 Nov 2018 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 25 Sep 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recreational runners | – | Diagnostic Test: Maximal incremental running test, Diagnostic Test: Metabolic and movement analysis of running, Other: QuestionnairesRecreational 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- recreational runners
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.).
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 |
|---|---|---|
| Maximal incremental running testMaximal 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 | recreational runners |
| Metabolic and movement analysis of runningRunning 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 | Diagnostic test | recreational runners |
| QuestionnairesMonthly follow-up questionnaire (12 months) about training habits and injuries | Other | recreational runners |
Primary outcome
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 .
3 secondary outcomes
Correlation between running gait harmonicity and spatio-temporal running parameters
Time frame: 1 year
Correlation between running gait harmonicity and metabolic parameters
Time frame: 1 year
Correlation between running related injuries (RRI) and running gait harmonicity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 30558916Huijben 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.
- Results publication: PubMed 25495782Lindsay 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.
- Results publication: PubMed 19966104Buist 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.
- Results publication: PubMed 25951917Videbaek 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.
- Results publication: PubMed 17473005van 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.
- Results publication: PubMed 16005398Hreljac 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.
- Results publication: PubMed 25202853Vannatta 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.
- Results publication: PubMed 25155651Teng 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.
- Results publication: PubMed 25729311Valenzuela 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.
- Results publication: PubMed 23186012Hamill 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.
- Results publication: PubMed 27148098Kiely 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.
- Results publication: PubMed 22921763Bredeweg 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.
- Individual participant dataSharing planned: Undecided
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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.
Guido Pasquini, Bs principal investigator
IRCCS Fondazione Don Carlo Gnocchi
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 Injuries, run by Fondazione Don Carlo Gnocchi ETS 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between running related injuries (RRI) and running gait harmonicity (time frame: 1year). 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 NCT04103437, which also lists 15 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 24 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.