Lower Limb AmputationSTSTNCT04293237
Metric Charcteristics of Sit-to-stand Tests in Patients After Lower-limb Amputation
An observational study of Lower Limb Amputation, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- How many people
- 36 participants
- Where
- 1 siteSlovenia
- Study dates
- 26 Feb 2020to 9 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, 1000
About this study
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.
Read the 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).
- Conditions
- Lower Limb Amputation
- Keywords
- unilateral lower-limb amputation, sit-to-stand tests, walking tests, psychometric characteristics
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two weeks after the start of the study
Secondary outcomes (3)
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.
Measured: At the start of the study and after two weeks
10-Metre Walk Test (10mWT)
The 10mWT assesses walking speed over a short duration.
Measured: 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.
Measured: At the start of the study and after two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start26 Feb 2020
- Primary completion9 May 2020
- Study completion9 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies 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
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronika Podlogar, MPT, Principal investigator, University Rehabilitation Institute, Republic of Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293237
- Sponsor's protocol ID
- URIS202002
- Acronym
- STST
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metric Charcteristics of Sit-to-stand Tests in Patients After Lower-limb Amputation
- ClinicalTrials.gov ID
- NCT04293237
- Acronym / sponsor ID
- STST / URIS202002
- Conditions
- Lower Limb Amputation
- Keywords
- unilateral lower-limb amputation, sit-to-stand tests, walking tests, psychometric characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 9 May 2020 (actual)
- Study completion
- 9 May 2020 (actual)
- First posted
- 3 Mar 2020 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Five Times Sit to Stand Test (5TSTS) - Start
Time frame: At the start of the study
The 5TSTS assesses functional lower extremity strength, transitional movements and balance. The outcome is the tame required by the participant to complete the task.
Five Times Sit to Stand Test (5TSTS) - After one day
Time frame: One day after the start of the study
The 5TSTS assesses functional lower extremity strength, transitional movements and balance. The outcome is the tame required by the participant to complete the task.
Five Times Sit to Stand Test (5TSTS) - After two weeks
Time frame: Two weeks after the start of the study
The 5TSTS assesses functional lower extremity strength, transitional movements and balance. The outcome is the tame required by the participant to complete the task.
30-Second Sit to Stand Test (30SSTS) - Start
Time frame: At the start of the study
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.
30-Second Sit to Stand Test (30SSTS) - After one day
Time frame: One day after the start of the study
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.
30-Second Sit to Stand Test (30SSTS) - After two weeks
Time frame: Two weeks after the start of the study
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.
3 secondary outcomes
L-test
Time frame: At the start of the study and after two weeks
10-Metre Walk Test (10mWT)
Time frame: At the start of the study and after two weeks
6-Minute Walk Test (6mWT)
Time frame: At the start of the study and after two weeks
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 15 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Veronika Podlogar, MPT principal investigator
University Rehabilitation Institute, Republic of Slovenia
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 Lower Limb Amputation, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
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 3 inclusion and 4 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 15 Feb 2021. 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 Slovenia. 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?
Five Times Sit to Stand Test (5TSTS) - Start (time frame: At the start of the study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.