- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06001229
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
Not yet recruiting
Conditions
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
Observational
Enrollment (Estimated)
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
- Name: Aynur Demirel
- Phone Number: +903123051576
- Email: aynur.demirel@hacettepe.edu.tr
Study Contact Backup
- Name: Cansu Akkuş
- Phone Number: +905426582390
- Email: cansu.akkus@hacettepe.edu.tr
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
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
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
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
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)
August 18, 2023
Primary Completion (Estimated)
June 22, 2024
Study Completion (Estimated)
June 22, 2024
Study Registration Dates
First Submitted
August 14, 2023
First Submitted That Met QC Criteria
August 14, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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