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NCT Number: NCT06162117

Validity and Reliability of the Two-Minute Step Test in 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.

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Key information

Conditions

Meniscus Tear

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Physical Medicine and Rehabilitation Research and Training Hospital, Istanbul, Bahcelievler, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2- Minute Step Test

Diagnostic Test

2- Minute Step Test will be administered to patients with traumatic meniscus tear

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

Validity and Reliability of the Two-Minute Step Test in Patients With Traumatic Meniscal Tear

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2023
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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