Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06344182
• Other study ID #: STarkan
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: May 15, 2021

Study information

• Verified date: March 2024
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with primary TKA who are at least six months post-surgery
• Patients over 40 years of age

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Other:
• Step Up and Down Test
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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Almeida 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. — View Citation

Eymir 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. — View Citation

Narin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital for Special Surgery (HSS) Knee Score	The HSS knee score criteria are based on a total of 100 points. The score consists of seven categories: Pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions.	2021
Other	12-Item Short-Form Health Survey	Health-related quality of life (HRQOL) was assessed with the Short Form Health Survey-12 (SF-12).	2021
Primary	Step Up and Down Test	In the StUD test, the patient completes maximum number of step-up-down repetitions in 15 seconds.	2021
Secondary	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.	2021