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

This study is designed to explore the validity and reliability of the two-minute step test as an assessment method for functional capacity in patients diagnosed with traumatic meniscal tear. The objective is to determine the effectiveness of this test in accurately measuring the functional abilities of individuals with traumatic meniscus tears. By focusing on patients who have been diagnosed with such injuries and employing the two-minute step test, the study aims to provide valuable insights into the suitability of this evaluation tool for assessing functional capacity in this specific patient population. The findings of this research have the potential to contribute significantly to the clinical understanding and management of traumatic meniscal tears, offering clinicians a reliable and valid method for evaluating the functional capabilities of affected individuals.

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

    • Bahcelievler
      • Istanbul, Bahcelievler, Turkey, 34147
        • İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
    • Beylikdüzü
      • Istanbul, Beylikdüzü, Turkey, 34147
        • Beylikdüzü State Hospital

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with traumatic meniscus tear

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

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

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

February 21, 2024

Primary Completion (Actual)

March 21, 2024

Study Completion (Actual)

March 21, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IstPRMTRHmeniscus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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