Meniscus TearNCT06162117
Validity and Reliability of the Two-Minute Step Test in Traumatic Meniscal Tear
An observational study of Meniscus Tear, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- 2- Minute Step Test
- How many people
- 55 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Feb 2024to 21 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with traumatic meniscus tear
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Presence of degenerative diseases affecting lower limb functions
- Peripheral artery disease causing vascular claudication
- Psychiatric illness
- Neuromuscular disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Istanbul, Bahcelievler, 34147
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
Official title: 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.
Read the 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.
- Conditions
- Meniscus Tear
- Being tested
- 2- Minute Step Test
- Keywords
- Exercise test, Meniscus, Physical fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2- Minute Step TestDiagnostic test
2- Minute Step Test will be administered to patients with traumatic meniscus tear
| Study group | Role | What they receive |
|---|---|---|
| Traumatic meniscus tear | Patients with traumatic meniscus tears will be enrolled in this study Receives: Diagnostic Test: 2- Minute Step Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 day and 1th week
Secondary outcomes (4)
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).
Measured: 0 day
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.
Measured: 0 day
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.
Measured: 0 day
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.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start21 Feb 2024
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162117
- Sponsor's protocol ID
- IstPRMTRHmeniscus
- Status last verified
- Oct 2024
- First submitted
- 30 Nov 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35615563de 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.
PubMed 36471309de 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.
PubMed 35177048
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Two-Minute Step Test in Patients With Traumatic Meniscal Tear
- ClinicalTrials.gov ID
- NCT06162117
- Acronym / sponsor ID
- IstPRMTRHmeniscus
- Conditions
- Meniscus Tear
- Keywords
- Exercise test, Meniscus, Physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic meniscus tear | – | Diagnostic Test: 2- Minute Step TestPatients with traumatic meniscus tears will be enrolled in this study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with traumatic meniscus tear
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2- Minute Step Test2- Minute Step Test will be administered to patients with traumatic meniscus tear | Diagnostic test | Traumatic meniscus tear |
Primary outcome
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.
4 secondary outcomes
The Pain Self-Efficacy Questionnaire
Time frame: 0 day
Pain Catastrophizing Scale
Time frame: 0 day
Western Ontario Meniscal Evaluation Tool
Time frame: 0 day
Visual Analogue Scale
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Background: PubMed 35615563Oliveros 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.
- Results publication: PubMed 36471309de 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.
- Results publication: PubMed 35177048de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Tear, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-Minute Step Test (time frame: 0 day and 1th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162117, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.