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

NCT04293237 | Completed

• 1 other identifier: URIS202002
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Limb Amputation

Keywords

unilateral lower-limb amputation; sit-to-stand tests; walking tests; psychometric characteristics

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• L-test

  At the start of the study and after two weeks

• 10-Metre Walk Test (10mWT)

  At the start of the study and after two weeks

• 6-Minute Walk Test (6mWT)

  At the start of the study and after two weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Study Officials

• Veronika Podlogar, MPT

  University Rehabilitation Institute, Republic of Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 3, 2020
• Study Start: February 26, 2020
• Primary Completion: May 9, 2020
• Study Completion: May 9, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)