Clinical trial NCT06162117: Validity and Reliability of the Two-Minute Step Test in Traumatic Meniscal Tear
Official title: Validity and Reliability of the Two-Minute Step Test in Patients With Traumatic Meniscal Tear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meniscus Tear
Keywords: Exercise test
Meniscus
Physical fitness
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with traumatic meniscus tear

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Two-Minute Step Test
timeFrame: 0 day and 1th week
Secondary outcomes:
measure: The Pain Self-Efficacy Questionnaire
timeFrame: 0 day
measure: Pain Catastrophizing Scale
timeFrame: 0 day
measure: Western Ontario Meniscal Evaluation Tool
timeFrame: 0 day
measure: Visual Analogue Scale
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
state: Bahcelievler
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.