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

Meniscus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162117
• Other study ID #: IstPRMTRH7
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: March 21, 2024

Study information

• Verified date: February 2024
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: Büsra Sirin Ahisha, MD
• Phone: (0212) 856 27 40
• Email: bsrn080[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to explore the validity and reliability of the two-minute walk 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 walk 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.

Description:

The study is planned as a prospective 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 two different evaluators, requires the patient to have rested for at least 30 minutes before starting, and there will be a minimum of 30 minutes of rest between the tests conducted by the two evaluators. 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. One week after the assessment, the 2-Minute Step Test will be repeated by the same two evaluators."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients aged between 18 and 45 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 45
• 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

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

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

Locations

Country	Name	City	State
Turkey	Beylikdüzü State Hospital	Istanbul	Beylikdüzü
Turkey	Istanbul Physical Medicine and Rehabilitation Research and Training Hospital	Istanbul	Bahcelievler

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 Muscul — View 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/s12891-022-05 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-Minute Step Test	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	The Pain Self-Efficacy Questionnaire	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
Secondary	Pain Catastrophizing Scale	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
Secondary	Western Ontario Meniscal Evaluation Tool	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
Secondary	Visual Analogue Scale	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