NCT06162117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

29 days

First QC Date

November 30, 2023

Last Update Submit

October 16, 2024

Conditions

Keywords

Exercise testMeniscusPhysical fitness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The Pain Self-Efficacy Questionnaire

    0 day

  • Pain Catastrophizing Scale

    0 day

  • Western Ontario Meniscal Evaluation Tool

    0 day

  • Visual Analogue Scale

    0 day

Study Arms (1)

Traumatic meniscus tear

Patients with traumatic meniscus tears will be enrolled in this study

Diagnostic Test: 2- Minute Step Test

Interventions

2- Minute Step TestDIAGNOSTIC_TEST

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

Traumatic meniscus tear

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with traumatic meniscus tear

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

İstanbul Physical Medicine and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, 34147, Turkey (Türkiye)

Location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 35615563BACKGROUND
  • 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 Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

February 21, 2024

Primary Completion

March 21, 2024

Study Completion

March 21, 2024

Last Updated

October 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations