Retest-reliability and At-home-assessment Feasibility of the 5R-STS (5RSTS-2)
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|ClinicalTrials.gov Identifier: NCT03321357|
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : July 13, 2018
The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine.
The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.
|Condition or disease||Intervention/treatment|
|Degenerative Disc Disease Spondylolisthesis Spondylosis Herniated Nucleus Pulposus Spinal Stenosis Lumbar Spinal Diseases Spinal Instability||Diagnostic Test: five-repetition sit-to-stand test|
Patients will perform three 5R-STS measurements:
- During outpatient clinics, time measured by the physician
- At home, time measured by partner/family
- At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)|
|Actual Study Start Date :||December 8, 2017|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 21, 2018|
- Diagnostic Test: five-repetition sit-to-stand test
An armless chair with a hard seat was stabilised by placing it against a wall. Seated participants were asked to come forward on the chair seat until the feet were flat on the floor and to fold their upper limbs across the chest. Participants were then instructed to stand up all the way and sit down once without using the upper limbs. For those unable to complete the initial manoeuvre or who required assistance, the test was terminated. If successful on the initial sit to stand, participants were then asked to stand up all the way and sit down landing firmly, as fast as possible, five times without using the arms. Timing with a stopwatch was started on the command 'go' and stopped at the end of the completed fifth stand; the time taken was recorded as the participant's score.
(1) Jones et al.Other Name: 5R-STS
- 5R-STS [ Time Frame: 0 months ]Objective functional test measuring the amount of functional impairment.
- EQ-5D-3L [ Time Frame: 0 months ]Validated questionnaire measuring quality of life
- Oswestry Disability Index [ Time Frame: 0 months ]Validated questionnaire measuring functional disability
- VAS leg pain severity [ Time Frame: 0 months ]Validated questionnaire measuring pain
- VAS back pain severity [ Time Frame: 0 months ]Validated questionnaire measuring pain
- Roland Morris Disability Questionnaire [ Time Frame: 0 months ]Validated questionnaire measuring functional disability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321357
|Naarden, Netherlands, 1411 GE|
|Principal Investigator:||Victor E. Staartjes, MSIII||Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands|