Metric Charcteristics of Sit-to-stand Tests in Patients After Lower-limb Amputation (STST)

The aim of the study is to assess various aspects of reliability and validity of two sit-to-stand tests, the Five Times Sit to Stand Test (5TSTS) and the 30-Second Sit to Stand Test (30SSTS). The tests will be performed by patients after lower-limb amputation who have been newly fitted with a prosthesis. Each test will be performed with and without the prosthesis on two occasions: on the first day when the patients will be able to walk independently with their prosthesis and two weeks later. On the same two occasions, the patients will also perform three walking tests (in randomised order): the L-test, the 10-Metre Walk Test and the 6-Minute Walk Test. In addition, the patients will repeat the 5TSTS and the 30SSTS one day after the first assessment. The results will be used to detect the presence of a floor effect, assess repeatability and concurrent validity, as well as estimate minimal detectable change and effects size for the effect of rehabilitation.

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation

Detailed Description

All the tests will be performed using standardised protocols and technical aids. The assessments will be performed in the afternoon (after the daily rehabilitation program). The patients who will be able to perform the 5TSTS will perform that test first. If those patients will bill able to stand up within 30 seconds on each of the five trials, the 30SSTS will be performed next; otherwise, the number of times that the patient was able to complete the transition to the standing position will be recorded and taken as the 30SSTS result. Repetition of the outcome measurements will not serve to simply use the differences as the actual outcomes, but will serve to assess floor effect (the percentage of patients attaining the minimum possible score) on each occasion, to assess repeatability (intra-class correlation between the measurements on two consecutive days), minimal detectable change (calculated from the standard error of measurement, which will be estimated from the correlation between the measurements at the start and after two weeks) and effect size (difference between the mean measurements at the start and after two weeks, divided by the standard deviation at the start). In addition, the repeated measurements will be used to assess concurrent validity in terms of the correlation between the sit-to-stand tests and the walking tests on two occasions (at the start and after two weeks).

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Rehabilitation Institute, Republic of Slovenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to impatient rehabilitation at the Department for Rehabilitation of Patients after Amputation of the University Rehabilitation Institute in Ljubljana, Slovenia, who will meet the inclusion criteria and not meet any of the exclusion criteria will be consecutively recruited until the planned sample size is reached

Description

Inclusion Criteria:

• unilateral trans-femoral or trans-tibial amputation
• fitted with a prosthesis for the first time
• being able to walk with the prosthesis independently (without walking aids or using a cane, crutch or walker)

Exclusion Criteria:

• balance disorder beacuse of neurological disease
• other muskuloskeletal impairments affecting the outcome measurements
• cardio-vascular disease that could be worsened by prforming the outcome measurements
• general ill health

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Times Sit to Stand Test (5TSTS) - Start	The 5TSTS assesses functional lower extremity strength, transitional movements and balance. The outcome is the tame required by the participant to complete the task.	At the start of the study
Five Times Sit to Stand Test (5TSTS) - After one day	The 5TSTS assesses functional lower extremity strength, transitional movements and balance. The outcome is the tame required by the participant to complete the task.	One day after the start of the study
Five Times Sit to Stand Test (5TSTS) - After two weeks	The 5TSTS assesses functional lower extremity strength, transitional movements and balance. The outcome is the tame required by the participant to complete the task.	Two weeks after the start of the study
30-Second Sit to Stand Test (30SSTS) - Start	The 30SSTS assesses leg strength and endurance. The outcome is the number of times that the participant is able to completely stand up from the chair within 30 secons.	At the start of the study
30-Second Sit to Stand Test (30SSTS) - After one day	The 30SSTS assesses leg strength and endurance. The outcome is the number of times that the participant is able to completely stand up from the chair within 30 secons.	One day after the start of the study
30-Second Sit to Stand Test (30SSTS) - After two weeks	The 30SSTS assesses leg strength and endurance. The outcome is the number of times that the participant is able to completely stand up from the chair within 30 secons.	Two weeks after the start of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
L-test	The L-test is a performance-based measure of functional mobility. It is a modification of the Timed Up and Go test that overcomes the ceiling effect in higher-functioning patients. The participant must stand up from the chair, walk 7 m, turn 90 degrees, walk 3 m, then turn 180 degrees, and return along the same path to sit in the chair.	At the start of the study and after two weeks
10-Metre Walk Test (10mWT)	The 10mWT assesses walking speed over a short duration.	At the start of the study and after two weeks
6-Minute Walk Test (6mWT)	The 6mWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome.	At the start of the study and after two weeks

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia
• Investigators: Principal Investigator: Veronika Podlogar, MPT, University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): May 9, 2020
• Study Completion (Actual): May 9, 2020

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: unilateral lower-limb amputation; sit-to-stand tests; walking tests; psychometric characteristics
• Other Study ID Numbers: URIS202002

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