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

Lower Limb Amputation Clinical Trial

— STST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293237
• Other study ID #: URIS202002
• Status: Completed
• Start date: February 26, 2020
• Est. completion date: May 9, 2020

Study information

• Verified date: February 2021
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 9, 2020
• Est. primary completion date: May 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	10-Metre Walk Test (10mWT)	The 10mWT assesses walking speed over a short duration.	At the start of the study and after two weeks
Secondary	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