Locomotor Pain DisorderNCT05535153
Reproducibility of the Functional Movement Screen Test
An observational study of Locomotor Pain Disorder, run by Pole Sante Grace de Dieu at 1 site in France.
Trial summary
The main objective of the study is to determine the inter-evaluator and intra-evaluator reproducibility of the FMS test as an evaluation tool in amateur rugby players. The secondary objective of the study is to evaluate the abilities of the FMS test as a predictive tool for detecting possible injuries during a sports… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Locomotor Pain Disorder
- What is being tested?
- functional movement screen
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2022to 31 May 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The subjects recruited are rugby players aged 18 to 55, playing or having played in the "Amateur" and "Senior" categories.
Who may be able to join
- Rugby players in the "Amateur" and "Senior" categories
- Must be able to play a match within a week of the FMS test evaluation.
Who cannot join
- players evolving or having evolved beyond the "Federal 3" division for men or "Federal 1" for women
- Pregnant and breastfeeding women
- People in an emergency situation
- People unable to give their consent (including people under guardianship)
- Patients already involved in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproducibility of the Functional Movement Screen Test in the Normandy Amateur Rugby Player
The main objective of the study is to determine the inter-evaluator and intra-evaluator reproducibility of the FMS test as an evaluation tool in amateur rugby players.
The secondary objective of the study is to evaluate the abilities of the FMS test as a predictive tool for detecting possible injuries during a sports season in amateur rugby players.
Read the detailed description
Rugby is a very popular sport in France, since it has more than 300,000 dismissed. The 2023 World Cup will take place in France, and in view of the enthusiasm that is created around the "XV de France" team, there will be a great number of new players. Yet there are many injuries in this sport, despite the adaptations of the French Rugby Federation. The injuries of these amateur players will handicap their performance within their club (an injured player will be injured more easily in the future) and have a impact on their personal and professional life. With this in mind, it would be desirable to have a predictive tool for possible wounds. For this, Agullo et al. had in the previous study "Reproducibility of the Functional Movement Screen (FMS) test in the amateur Rugby player" (ID-RCB: 2018-A03490-55) selected this tool already evaluated in the context of prediction injuries in other sports (hockey or American football). The FMS offers an overall assessment of the subject, based on seven so-called movements fundamentals, combining mobility and stability, making it possible to assess the deficiencies of the individual; a prevention plan will then be adapted to the subject.
- Conditions
- Locomotor Pain Disorder
- Being tested
- functional movement screen
- Keywords
- FMS, rugby
- Medical subject headings
- Collagen Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional movement screenOther
The volunteer subjects had to perform the FMS test at the request of the investigator, which is made up of seven movements: the squat, the crossing of the hurdle, the line lunge, the active elevation with the straight leg, a movement concerning the mobility of the shoulders, a rotational stability assessment movement and a core stability assessment movement.
| Study group | Role | What they receive |
|---|---|---|
| Experime | Hurdle steps Deep squats Inline lunges Shoulder Clearing Active straight leg raise Trunk stability pushup Rotary stability Spinal extension exam Spinal flexion exam Receives: Other: functional movement screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Movement Screen
Intraclass correlation coefficient with data : FMS score between rater one and rater two
Measured: 1 year
Secondary outcomes (1)
Functional Movement Screen
Functional Movement Screen (FMS) will be used as a assessment tool to screen the risk of injury in rugby
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Aug 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locomotor Pain DisorderStudies of the same condition, open and under way.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pole Sante Grace de Dieu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume GALLIOU, Pole Sante Grace de Dieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535153
- Sponsor's protocol ID
- 20220101
- Status last verified
- Sep 2023
- First submitted
- 16 Aug 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of the Functional Movement Screen Test in the Normandy Amateur Rugby Player
- ClinicalTrials.gov ID
- NCT05535153
- Acronym / sponsor ID
- 20220101
- Conditions
- Locomotor Pain Disorder
- Keywords
- FMS, rugby
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Pole Sante Grace de DieuUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Sep 2022 (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.
The main objective of the study is to determine the inter-evaluator and intra-evaluator reproducibility of the FMS test as an evaluation tool in amateur rugby players.
The secondary objective of the study is to evaluate the abilities of the FMS test as a predictive tool for detecting possible injuries during a sports season in amateur rugby players.
Detailed description
Rugby is a very popular sport in France, since it has more than 300,000 dismissed. The 2023 World Cup will take place in France, and in view of the enthusiasm that is created around the "XV de France" team, there will be a great number of new players. Yet there are many injuries in this sport, despite the adaptations of the French Rugby Federation. The injuries of these amateur players will handicap their performance within their club (an injured player will be injured more easily in the future) and have a impact on their personal and professional life. With this in mind, it would be desirable to have a predictive tool for possible wounds. For this, Agullo et al. had in the previous study "Reproducibility of the Functional Movement Screen (FMS) test in the amateur Rugby player" (ID-RCB: 2018-A03490-55) selected this tool already evaluated in the context of prediction injuries in other sports (hockey or American football). The FMS offers an overall assessment of the subject, based on seven so-called movements fundamentals, combining mobility and stability, making it possible to assess the deficiencies of the individual; a prevention plan will then be adapted to the subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experime | – | Other: functional movement screenHurdle steps Deep squats Inline lunges Shoulder Clearing Active straight leg raise Trunk stability pushup Rotary stability Spinal extension exam Spinal flexion exam |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The subjects recruited are rugby players aged 18 to 55, playing or having played in the "Amateur" and "Senior" categories.
Key inclusion criteria (2 listed)
- Rugby players in the "Amateur" and "Senior" categories
- Must be able to play a match within a week of the FMS test evaluation.
Key exclusion criteria (5 listed)
- players evolving or having evolved beyond the "Federal 3" division for men or "Federal 1" for women
- Pregnant and breastfeeding women
- People in an emergency situation
- People unable to give their consent (including people under guardianship)
- Patients already involved in another study.
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 |
|---|---|---|
| functional movement screenThe volunteer subjects had to perform the FMS test at the request of the investigator, which is made up of seven movements: the squat, the crossing of the hurdle, the line lunge, the active elevation with the straight leg, a movement concerning the mobility of the shoulders, a rotational stability assessment movement and a core stability assessment movement. | Other | Experime |
Primary outcome
Functional Movement Screen
Time frame: 1 year
Intraclass correlation coefficient with data : FMS score between rater one and rater two
1 secondary outcome
Functional Movement Screen
Time frame: through study completion, an average of 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 6 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Locomotor Pain Disorder, run by Pole Sante Grace de Dieu at 1 site in France.
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 2 inclusion and 5 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 6 Sep 2023. 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 France. 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?
Functional Movement Screen (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2023.