Reliability and Validity of the 2-Minute Step Test in Patients With Knee Arthroplasty

September 25, 2023 updated by: Hakan AKKAN, Kutahya Health Sciences University
Total knee arthroplasty (TKA) is a cost-effective treatment for end-stage knee osteoarthritis. It has demonstrable benefits such as reducing pain and improving activity and quality of life. Despite the decrease in pain after surgery, the expectations of patients regarding their physical functions are not fully realized. Physical performance tests and reporting tests are used to objectively evaluate physical function and reveal the patient's condition. It is known that physical performance tests better reflect post-surgical changes. In addition, it has been stated that there may be serious differences between the results of the reports based tests and the actual functional capacities of the patients. The 2-minute walk test and the 6-minute walk test are tests that are used in the evaluation of lower extremity physical performance and have been shown to be valid and reliable in different populations. However, a certain length of corridor is needed in order to carry out these timed walking tests. As an alternative to these, another test used in the evaluation of physical performance is the 2-minute step test. This test, which was developed in 1999, does not require much equipment and space, so the test can be easily applied in any environment. In this test, a height specific to each individual is determined (as high from the ground as the distance between the Spina iliaca anterior superior and the midpoint of the patella), and the participant is asked to raise and lower both knees, respectively, to this height for 2 minutes. These tests used in the evaluation of patients should be valid, reliable and sensitive. In clinical studies, reliability is an important psychometric property. Because stable data are necessary to provide accurate data on treatment effects or the amount of change observed over time. Another important psychometric property is validity. Validity is defined as the degree to which a concept is accurately measured in a quantitative study. Reliability studies of the 2-minute step test in active and sedentary lean adults have been conducted, but the psychometric evaluations necessary for its routine use in patients with TDP have not been performed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a non-experimental, descriptive methodological study. Forty-nine patients who applied to the outpatient clinic of Kütahya Health Sciences University, Evliya Çelebi Training and Research Hospital due to knee osteoarthritis, will included in the study. Pre-study power analysis was performed and the power to detect clinically significant difference was calculated as 90% (5% Type I error level). The smallest sample size to be taken was determined by using the sample size creation section in the G-Power (version 3.0.10) program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kütahya, Turkey
        • Kutahya Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who have undergone total knee replacement surgery with age of older than 18.

Description

Inclusion Criteria:

  • Being 18 years or older
  • Having been diagnosed with knee OA by an orthopedic specialist and having a knee prosthesis applied.

Exclusion Criteria:

  • Those who do not understand verbal and written information in Turkish
  • Patients who underwent complex surgery requiring bone grafting
  • Those with orthopedic or neurological disease causing gait disturbance
  • Those with pain of 5 or more on the numerical pain scale
  • Those with a history of Myocardial Infarction
  • Those who have undergone surgery in the last 6 months
  • Those with concomitant heart failure
  • Those with unstable angina
  • Those with uncontrolled hypertension
  • Those with severe COPD, Asthma and Interstitial Lung Disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Total Knee Replacement
Patients who have undergone total knee replacement
Diagnostic test: 2-minute step test
The participant stands and counts for 2 minutes. The minimum height to raise the knee is determined for each participant by calculating the midpoint between the patella and the anterior superior iliac spine. They are instructed to complete as many steps as possible during the 2-minute period. A verbal command is given every 30 seconds to encourage performance: "You're doing great, keep it up." If the claudication symptom becomes unbearable, the patient can stop during the test, but the time is not stopped. Patients who discontinue testing due to symptoms of claudication are encouraged to return to testing as soon as possible. An evaluator records the number of steps in the right leg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital for Special Surgery Knee-Rating Scale
Time Frame: Baseline
The Hospital for Special Surgery knee-rating scale was developed to be used as a standardized tool to measure outcomes in patients with osteoarthritis and knee arthroplasty. The scale can be used to evaluate the patient before surgery and to monitor knee function after surgery. Hospital for Special Surgery knee rating scale is widely used in the clinic by physiotherapists and orthopaedic surgeons.
Baseline
Numerical Pain Scale
Time Frame: Baseline
The pain levels of the patients will be determined using the Numerical Pain Scale (NPS). This scale is a score containing values between 0-10 on a 10 cm horizontal line. In scoring, 0 points indicates the absence of pain, while 10 points means unbearable pain. Patients are asked to mark the part that is equivalent to their own pain on the 10 cm line. Thus, the pain level of the patients is determined.
Baseline
2-Minute Step Test
Time Frame: Baseline
The participant stands and counts for 2 minutes. The minimum height to raise the knee is determined for each participant by calculating the midpoint between the patella and the anterior superior iliac spine. They are instructed to complete as many steps as possible during the 2-minute period. A verbal command is given every 30 seconds to encourage performance: "You're doing great, keep it up." If the claudication symptom becomes unbearable, the patient can stop during the test, but the time is not stopped. Patients who discontinue testing due to symptoms of claudication are encouraged to return to testing as soon as possible. An evaluator records the number of steps in the right leg.
Baseline
6-Minute Walking Test
Time Frame: Baseline
The participant is asked to walk as far as possible along a 30-meter straight corridor in a 6-minute period. Running is not allowed. The evaluator gives the standard incentive "you are doing well, keep going" every minute during the test. The distance traveled in 6 minutes is recorded in meters.
Baseline
2-Minute Walk Test
Time Frame: Baseline
Participants are asked to walk within 2 minutes along a 30 m indoor corridor. They are not allowed to talk while walking. The distance walked is recorded in meters.
Baseline
2-Minute Step Test
Time Frame: Within same day after the baseline
The participant stands and counts for 2 minutes. The minimum height to raise the knee is determined for each participant by calculating the midpoint between the patella and the anterior superior iliac spine. They are instructed to complete as many steps as possible during the 2-minute period. A verbal command is given every 30 seconds to encourage performance: "You're doing great, keep it up." If the claudication symptom becomes unbearable, the patient can stop during the test, but the time is not stopped. Patients who discontinue testing due to symptoms of claudication are encouraged to return to testing as soon as possible. An evaluator records the number of steps in the right leg.
Within same day after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kutahya Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hakan Akkan, Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KutahyaHSU-AKKAN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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