- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06162117
Validity and Reliability of the Two-Minute Step Test in Traumatic Meniscal Tear
Validity and Reliability of the Two-Minute Step Test in Patients With Traumatic Meniscal Tear
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is planned as a cross-sectional clinical study. Fifty-five patients diagnosed with traumatic meniscal tear who apply to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital clinics will be included in the study. Patients must have a previous diagnosis of traumatic meniscal tear based on magnetic resonance imaging.
Sociodemographic data such as age, height, weight, body mass index, marital status, education level, and occupation will be recorded. The level of impairment in daily activities of patients with meniscal tear will be assessed using the Western Ontario Meniscus Evaluation Questionnaire. Pain intensity will be evaluated using the Visual Analog Scale, a linear scale of 10 cm. The Pain Catastrophizing Scale will be used to assess the patient's level of distress due to pain. The patient's confidence level in performing different activities due to pain will be evaluated using the Pain Self-Efficacy Questionnaire.
The patient's physical function will be assessed using the 2-Minute StepTest. This test, to be administered by the same evaluator, requires the patient to have rested for at least 30 minutes before starting, and there will be a minimum of 1 hour of rest between the tests conducted. Before starting the tests, the patient's blood pressure, oxygen saturation, and heart rate will be measured, and if results are outside the normal range, the test will not proceed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bahcelievler
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Istanbul, Bahcelievler, Turkey, 34147
- İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
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Beylikdüzü
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Istanbul, Beylikdüzü, Turkey, 34147
- Beylikdüzü State Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged between 18 and 50 who have previously been diagnosed with traumatic meniscal tear through magnetic resonance imaging will be included in the study
Exclusion Criteria:
- Patients under the age of 18 and over the age of 50
- Patients with accompanying knee osteoarthritis
- Degenerative meniscal tears
- Uncontrolled hypertension
- Decompensated cardiac failure
- Presence of systemic diseases affecting lower limb functions
- Presence of degenerative diseases affecting lower limb functions
- Peripheral artery disease causing vascular claudication
- Psychiatric illness
- Neuromuscular disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Traumatic meniscus tear
Patients with traumatic meniscus tears will be enrolled in this study
|
2- Minute Step Test will be administered to patients with traumatic meniscus tear
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Two-Minute Step Test
Time Frame: 0 day and 1th week
|
During the administration of the Two-Minute Step Test, the midpoint between the anterior superior iliac spine and the patella of the patient is marked.
The patient is then instructed to take steps in place as quickly as possible for a duration of two minutes.
The knee should be lifted at least to the level of the marked point.
The number of steps taken by the patient within the two-minute period is recorded.
|
0 day and 1th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing Scale
Time Frame: 0 day
|
Individuals are required to express the extent to which they experience the thoughts and feelings mentioned above during pain using a scale of 0 (not at all) to 4 (all the time).
The overall score ranges from 0 to 52, and it also provides three subscale scores evaluating rumination, magnification, and helplessness.
|
0 day
|
|
The Pain Self-Efficacy Questionnaire
Time Frame: 0 day
|
The Pain Self-Efficacy Questionnaire comprises 10 items, with patients assigning confidence ratings on a scale from 0 points (indicating no confidence at all) to 6 points (indicating complete confidence).
Total scores are computed by summing up the individual items, resulting in a score range from 0 points (indicating lower self-efficacy) to 60 points (indicating higher self-efficacy).
|
0 day
|
|
Western Ontario Meniscal Evaluation Tool
Time Frame: 0 day
|
The Western Ontario Meniscal Evaluation Tool is a condition-specific instrument created for the assessment of Health-Related Quality of Life (HRQOL) in individuals with meniscal pathology. Comprising 16 items, it encompasses three domains. The physical symptom domain incorporates nine items, the combined domain covering sports, recreation, work, and lifestyle consists of four items, and the emotions domain includes three items. The best or least symptomatic score is 0, and the highest and most symptomatic score possible is 1,600. |
0 day
|
|
Visual Analogue Scale
Time Frame: 0 day
|
The Visual Analog Scale is a simple measurement tool consisting of a line with endpoints representing extreme points of a characteristic, such as "No Pain" to "Worst Pain Imaginable."
Respondents mark a point on the line to indicate their perception or experience of the given characteristic.
The distance from one endpoint to the marked point is then measured to quantify the subjective experience.
It's commonly used to assess various subjective factors like pain, fatigue, or mood.
|
0 day
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Oliveros MJ, Seron P, Roman C, Galvez M, Navarro R, Latin G, Marileo T, Molina JP, Sepulveda P, Marzuca-Nassr GN, Munoz S. Two-Minute Step Test as a Complement to Six-Minute Walk Test in Subjects With Treated Coronary Artery Disease. Front Cardiovasc Med. 2022 May 9;9:848589. doi: 10.3389/fcvm.2022.848589. eCollection 2022.
- de Jesus SFC, Bassi-Dibai D, Pontes-Silva A, da Silva de Araujo A, de Freitas Faria Silva S, Veneroso CE, de Paula Gomes CAF, Dibai-Filho AV. Construct validity and reliability of the 2-Minute Step Test (2MST) in individuals with low back pain. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1062. doi: 10.1186/s12891-022-06050-w.
- de Morais Almeida TF, Dibai-Filho AV, de Freitas Thomaz F, Lima EAA, Cabido CET. Construct validity and reliability of the 2-minute step test in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2022 Feb 17;23(1):159. doi: 10.1186/s12891-022-05114-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IstPRMTRHmeniscus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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