Total Knee ArthroplastyNCT06344182
Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to measure the validity and reliability of the StUD test in patients with TKA. Forty-seven patients with primary TKA included in this study. The test-retest reliability of the StUD test was measured with 1-hour interval. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Step Up and Down Test
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 15 May 2021
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary TKA who were operated on by the same surgeon using the paramedian approach were contacted by phone and volunteered to participate in this study. Patients with primary TKA who are at least six months post-surgery were included. Patients were selected and invited to the study by the surgeon and physiotherapist
Who may be able to join
- Patients with primary TKA who are at least six months post-surgery
- Patients over 40 years of age
Who cannot join
- having a body mass index (BMI) greater than 40 kg/m2,
- having had other surgery on a leg with TKA,
- having symptomatic hip OA,
- having a history of knee or hip fracture,
- having a previous orthopedic or neurological disease that prevents stepping
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to measure the validity and reliability of the StUD test in patients with TKA. Forty-seven patients with primary TKA included in this study. The test-retest reliability of the StUD test was measured with 1-hour interval. Validity was assessed that the 30s Chair Stand Test (30sCS), the Hospital for Special Surgery score (HSS) and Short Form-12 Quality Life Questionnaire (SF-12) were used as comparator instruments.
Read the detailed description
The study was designed as test-retest research. This study was approved by the ethics committee of Dokuz Eylul University, Izmir, Turkey. This study was conducted between 2021 and 2022 at the Dokuz Eylul University Hospital Orthopedics Department, Izmir, Turkey. Informed consent was obtained from all participants in accordance with the Declaration of Helsinki.
Sample Size The NCSS Trial and PASS 14 software (NCSS, LLC, Kaysville, Utah USA) was used to conduct the sample size. Power of 0.8 and an alpha level of 0.05 were used. Previous research on StUD in patients with knee Osteoarthritis was noted good test-retest reliability (ICC= 0.87) (G. P. L. Almeida et al., 2021). The test-retest reliability of the current study was thus hypothesized to be excellent. Assuming a %10 attrition rate, a null reliability with ICC=0.75 and expected reliability with ICC=0.90, 47 subjects would be needed.
Participant Forty-seven patients with primary TKA who were operated on by the same surgeon using the paramedian approach were contacted by phone and volunteered to participate in this study. Patients with primary TKA who are at least six months post-surgery were included. Patients were selected and invited to the study by the surgeon and physiotherapist.
Statistical Analysis All data were analyzed using the IBM SPSS Statistics (Version 23.0) software. The Kolmogorov-Smirnov/Shapiro-Wilk tests were used for the determination of the normal distribution. The difference between the pain levels before and after the trials was compared using the Paired Samples T test. The level of significance was determined p < .05. The correlations between the StUD and 30 CST, HSS, PCS12, and MCS12 were calculated to determine convergent validity. The convergent validity was analyzed based on the Spearman's correlation and was interpreted as follows: 0-0.09 = no correlation; 0.1-0.39 = weak correlation; 0.4-0.59 = moderate correlation; 0.7-0.89 = strong correlation; and 0.9-1 = perfect correlation. Paired samples' t test was used for comparing the difference between the first and second trials of StUD test. The intraclass correlation coefficient (ICC2,1) was used assess the test-retest reliability. The ICC values were interpreted as follows: poor, <0.5; moderate, 0.5-0.75; good, 0.75-0.9; excellent reliability, >0.9 (Koo \& Li, 2016). The standard error of measurement (SEM) was calculated as SD×√(1-ICC) , where SD is the pooled standard deviation from the first session. Minimal detectable change (MDC) was calculated at a 95% confidence level (MDC95). MDC95 was calculated according to following formula: MDC95=SEM×1.95×√2. All data were analyzed using the IBM SPSS Statistics (Version 23.0) software
- Conditions
- Total Knee Arthroplasty
- Being tested
- Step Up and Down Test
- Keywords
- Total Knee Arthroplasty, stair climbing, reliability, validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Up and Down TestOther
Step Up and Down Test In the StUD test, the patient completes maximum number of step-up-down repetitions in 15 seconds. Starting from a standing position, the participant took a full step up, leading with the test leg, then the non-testing leg, until both knees were fully extended and both hips were at least in neutral extension. In order to stress the testing limb concentrically and eccentrically, the participant stepped off the step first with the non-testing limb, then the testing limb. The patient was asked to repeat for 15 seconds as quickly as possible. The physical therapist stood to the side of the step for safety and so that he/she could observe the technique and ensure that the participant came to a full step up and down during the test.
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Up and Down Test
In the StUD test, the patient completes maximum number of step-up-down repetitions in 15 seconds.
Measured: 2021
Secondary outcomes (1)
30 Seconds Chair Stand Test
The 30 CST is a valid and reliable performance-based test to assess lower extremity muscle strength in patients with TKA.
Measured: 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Feb 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumeyya Tarkan, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344182
- Sponsor's protocol ID
- STarkan
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Almeida GJ, Schroeder CA, Gil AB, Fitzgerald GK, Piva SR. Interrater reliability and validity of the stair ascend/descend test in subjects with total knee arthroplasty. Arch Phys Med Rehabil. 2010 Jun;91(6):932-8. doi: 10.1016/j.apmr.2010.02.003.
PubMed 20510986Almeida GPL, Monteiro IO, Dantas RGO, Tavares MLA, Lima POP. Reliability, validity and responsiveness of the Step Up and Down (StUD) test for individuals with symptomatic knee osteoarthritis. Musculoskelet Sci Pract. 2021 Dec;56:102454. doi: 10.1016/j.msksp.2021.102454. Epub 2021 Sep 1.
PubMed 34482195Eymir M, Yuksel E, Unver B, Karatosun V. Reliability, validity, and minimal detectable change of the Step Test in patients with total knee arthroplasty. Ir J Med Sci. 2022 Dec;191(6):2651-2656. doi: 10.1007/s11845-021-02888-6. Epub 2022 Jan 13.
PubMed 35022951Narin S, Unver B, Bakirhan S, Bozan O, Karatosun V. Cross-cultural adaptation, reliability and validity of the Turkish version of the Hospital for Special Surgery (HSS) Knee Score. Acta Orthop Traumatol Turc. 2014;48(3):241-8. doi: 10.3944/AOTT.2014.3109.
PubMed 24901911
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06344182
- Acronym / sponsor ID
- STarkan
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, stair climbing, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 3 Apr 2024 (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.
The aim of the study is to measure the validity and reliability of the StUD test in patients with TKA. Forty-seven patients with primary TKA included in this study. The test-retest reliability of the StUD test was measured with 1-hour interval. Validity was assessed that the 30s Chair Stand Test (30sCS), the Hospital for Special Surgery score (HSS) and Short Form-12 Quality Life Questionnaire (SF-12) were used as comparator instruments.
Detailed description
The study was designed as test-retest research. This study was approved by the ethics committee of Dokuz Eylul University, Izmir, Turkey. This study was conducted between 2021 and 2022 at the Dokuz Eylul University Hospital Orthopedics Department, Izmir, Turkey. Informed consent was obtained from all participants in accordance with the Declaration of Helsinki.
Sample Size The NCSS Trial and PASS 14 software (NCSS, LLC, Kaysville, Utah USA) was used to conduct the sample size. Power of 0.8 and an alpha level of 0.05 were used. Previous research on StUD in patients with knee Osteoarthritis was noted good test-retest reliability (ICC= 0.87) (G. P. L. Almeida et al., 2021). The test-retest reliability of the current study was thus hypothesized to be excellent. Assuming a %10 attrition rate, a null reliability with ICC=0.75 and expected reliability with ICC=0.90, 47 subjects would be needed.
Participant Forty-seven patients with primary TKA who were operated on by the same surgeon using the paramedian approach were contacted by phone and volunteered to participate in this study. Patients with primary TKA who are at least six months post-surgery were included. Patients were selected and invited to the study by the surgeon and physiotherapist.
Statistical Analysis All data were analyzed using the IBM SPSS Statistics (Version 23.0) software. The Kolmogorov-Smirnov/Shapiro-Wilk tests were used for the determination of the normal distribution. The difference between the pain levels before and after the trials was compared using the Paired Samples T test. The level of significance was determined p < .05. The correlations between the StUD and 30 CST, HSS, PCS12, and MCS12 were calculated to determine convergent validity. The convergent validity was analyzed based on the Spearman's correlation and was interpreted as follows: 0-0.09 = no correlation; 0.1-0.39 = weak correlation; 0.4-0.59 = moderate correlation; 0.7-0.89 = strong correlation; and 0.9-1 = perfect correlation. Paired samples' t test was used for comparing the difference between the first and second trials of StUD test. The intraclass correlation coefficient (ICC2,1) was used assess the test-retest reliability. The ICC values were interpreted as follows: poor, <0.5; moderate, 0.5-0.75; good, 0.75-0.9; excellent reliability, >0.9 (Koo \& Li, 2016). The standard error of measurement (SEM) was calculated as SD×√(1-ICC) , where SD is the pooled standard deviation from the first session. Minimal detectable change (MDC) was calculated at a 95% confidence level (MDC95). MDC95 was calculated according to following formula: MDC95=SEM×1.95×√2. All data were analyzed using the IBM SPSS Statistics (Version 23.0) software
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary TKA who were operated on by the same surgeon using the paramedian approach were contacted by phone and volunteered to participate in this study. Patients with primary TKA who are at least six months post-surgery were included. Patients were selected and invited to the study by the surgeon and physiotherapist
Key inclusion criteria (2 listed)
- Patients with primary TKA who are at least six months post-surgery
- Patients over 40 years of age
Key exclusion criteria (5 listed)
- having a body mass index (BMI) greater than 40 kg/m2,
- having had other surgery on a leg with TKA,
- having symptomatic hip OA,
- having a history of knee or hip fracture,
- having a previous orthopedic or neurological disease that prevents stepping
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 |
|---|---|---|
| Step Up and Down TestStep Up and Down Test In the StUD test, the patient completes maximum number of step-up-down repetitions in 15 seconds. Starting from a standing position, the participant took a full step up, leading with the test leg, then the non-testing leg, until both knees were fully extended and both hips were at least in neutral extension. In order to stress the testing limb concentrically and eccentrically, the participant stepped off the step first with the non-testing limb, then the testing limb. The patient was asked to repeat for 15 seconds as quickly as possible. The physical therapist stood to the side of the step for safety and so that he/she could observe the technique and ensure that the participant came to a full step up and down during the test. | Other | – |
Primary outcome
Step Up and Down Test
Time frame: 2021
In the StUD test, the patient completes maximum number of step-up-down repetitions in 15 seconds.
1 secondary outcome
30 Seconds Chair Stand Test
Time frame: 2021
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 3 Apr 2024.
- Background: PubMed 20510986Almeida GJ, Schroeder CA, Gil AB, Fitzgerald GK, Piva SR. Interrater reliability and validity of the stair ascend/descend test in subjects with total knee arthroplasty. Arch Phys Med Rehabil. 2010 Jun;91(6):932-8. doi: 10.1016/j.apmr.2010.02.003.
- Background: PubMed 34482195Almeida GPL, Monteiro IO, Dantas RGO, Tavares MLA, Lima POP. Reliability, validity and responsiveness of the Step Up and Down (StUD) test for individuals with symptomatic knee osteoarthritis. Musculoskelet Sci Pract. 2021 Dec;56:102454. doi: 10.1016/j.msksp.2021.102454. Epub 2021 Sep 1.
- Background: PubMed 35022951Eymir M, Yuksel E, Unver B, Karatosun V. Reliability, validity, and minimal detectable change of the Step Test in patients with total knee arthroplasty. Ir J Med Sci. 2022 Dec;191(6):2651-2656. doi: 10.1007/s11845-021-02888-6. Epub 2022 Jan 13.
- Background: PubMed 24901911Narin S, Unver B, Bakirhan S, Bozan O, Karatosun V. Cross-cultural adaptation, reliability and validity of the Turkish version of the Hospital for Special Surgery (HSS) Knee Score. Acta Orthop Traumatol Turc. 2014;48(3):241-8. doi: 10.3944/AOTT.2014.3109.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by Dokuz Eylul University at 1 site 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 2 inclusion and 5 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Step Up and Down Test (time frame: 2021). 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 NCT06344182, which also lists 4 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 3 Apr 2024.