The Micheli Functional Scale's Validity and Reliability

August 14, 2023 updated by: Aynur Demirel, Hacettepe University

The Micheli Functional Scale's Validity and Reliability in Turkish Sport Groups

The purpose of this study is to assess the reliability and validity of the "Micheli Functional Scale" in the Turkish context.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The study will include a minimum of 80 individuals who are 16 years old or above, have been engaged in the same sports activity for at least two years, participate in physically demanding activities for at least three days a week, and possess the ability to read and write Turkish. Before participating in the study, athletes will be required to sign an informed consent form. Their demographic information will then be recorded.Before conducting the test, we will gather information about the athletes' history of low back pain using the extended Nordic musculoskeletal questionnaire. We will also use this questionnaire to identify any other musculoskeletal issues that the person may have.Two Turkish translators, fluent in English, will independently translate the original Micheli Functional Scale into Turkish. They will then discuss their translations and create a common one. The resulting translation will be translated back into English by two native English speakers who are also proficient in Turkish. These translations will be reviewed and combined into a single version. A Turkish scientist will evaluate the questionnaire for its suitability in the Turkish language. The final version will be tested on a small pilot group to determine its comprehensibility. After this, the questionnaire will be administered to the entire study group. To assess the validity of the Micheli Functional Scale, we will use the Oswestry Functional Questionnaire and the Ronald Morris Disability Questionnaire. One week after the test, we will repeat these surveys.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

To be eligible for the study, participants must be at least 16 years old, have been practicing the same sport for a minimum of 2 years, and engage in high-effort physical activity for at least 3 days per week. Additionally, those who are able to read and write in Turkish will be included in the study.

Description

Inclusion Criteria:

  • 16 years old and over
  • Having been doing the same sport for at least 2 years,
  • Participating in sports activities or activities that require a high level of effort at least 3 days a week,
  • Able to read and write Turkish

Exclusion Criteria:

  • Has a cognitive problem that prevents him from understanding and answering the questions or is taking a drug that may cause them,
  • Having a history of orthopedic or neurological injury or pain at a level that may prevent training or competition during the evaluation,
  • History of spine/lower and upper extremity surgery,
  • Structural deformities such as scoliosis and kyphosis,
  • Those with trap neuropathy will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Micheli Functional Scale
Time Frame: baseline and 1 week later
Evaluates the function linked to low back pain in athletes.
baseline and 1 week later
Oswestry Disability Index
Time Frame: baseline and 1 week later
Evaluate disability due to low back pain. the index measures perceived low back pain related dysfunction. Whether the total score increaeses, the dyscfunction increases.
baseline and 1 week later
Roland morris disability questionnaire
Time Frame: baseline and 1 week later
It is a questionnaire used to evaluate the disability level of individuals with low back pain. This questionnaire, consisting of 24 items, questions the person's social life, walking, sitting, standing, getting up from a chair, climbing stairs, dressing, personal care, pain, appetite, sleep, and psychological impact. The person answers the questions with yes and no. Yes is scored as 1 point and no as 0 points. The maximum score is "24" and the minimum score is "0". As the total score increases, the level of physical exposure also increases.
baseline and 1 week later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The musculoskeletal system problem
Time Frame: baseline
Nordic Musculoskeletal System Questionnaire
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO 22/540

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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