Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344182
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2024-03-27
Brief Title:
Reliability Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
Reliability Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 08 and an alpha level of 005 were used Previous research on StUD in patients with knee Osteoarthritis was noted good test-retest reliability ICC 087 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 ICC075 and expected reliability with ICC090 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 230 software The Kolmogorov-SmirnovShapiro-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 Spearmans correlation and was interpreted as follows 0-009 no correlation 01-039 weak correlation 04-059 moderate correlation 07-089 strong correlation and 09-1 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 ICC21 was used assess the test-retest reliability The ICC values were interpreted as follows poor 05 moderate 05-075 good 075-09 excellent reliability 09 Koo Li 2016 The standard error of measurement SEM was calculated as SD1-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 MDC95SEM1952 All data were analyzed using the IBM SPSS Statistics Version 230 software
Sample Size The NCSS Trial and PASS 14 software NCSS LLC Kaysville Utah USA was used to conduct the sample size Power of 08 and an alpha level of 005 were used Previous research on StUD in patients with knee Osteoarthritis was noted good test-retest reliability ICC 087 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 ICC075 and expected reliability with ICC090 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 230 software The Kolmogorov-SmirnovShapiro-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 Spearmans correlation and was interpreted as follows 0-009 no correlation 01-039 weak correlation 04-059 moderate correlation 07-089 strong correlation and 09-1 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 ICC21 was used assess the test-retest reliability The ICC values were interpreted as follows poor 05 moderate 05-075 good 075-09 excellent reliability 09 Koo Li 2016 The standard error of measurement SEM was calculated as SD1-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 MDC95SEM1952 All data were analyzed using the IBM SPSS Statistics Version 230 software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None