Clinical trial NCT03321357: Retest-reliability and At-home-assessment Feasibility of the 5R-STS
Official title: Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Spondylolisthesis
Spondylosis
Herniated Nucleus Pulposus
Spinal Stenosis Lumbar
Spinal Diseases
Spinal Instability
Lead sponsor: Bergman Clinics
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic degenerative diseases of the lumbar spine that come in for surgical treatment

Brief summary: 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.

Detailed description: Patients will perform three 5R-STS measurements:

1. During outpatient clinics, time measured by the physician
2. At home, time measured by partner/family
3. At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)

Eligibility criteria: Inclusion Criteria:

* Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
* Symptoms of lower back pain, neurogenic claudication, or radiculopathy

Exclusion Criteria:

* Hip or Knee prosthetics
* Walking aides

Primary outcomes:
measure: 5R-STS
timeFrame: 0 months
Secondary outcomes:
measure: EQ-5D-3L
timeFrame: 0 months
measure: Oswestry Disability Index
timeFrame: 0 months
measure: VAS leg pain severity
timeFrame: 0 months
measure: VAS back pain severity
timeFrame: 0 months
measure: Roland Morris Disability Questionnaire
timeFrame: 0 months
Other outcomes:
Locations:
city: Naarden
country: Netherlands
facility: Bergman Clinics
Study officials:
affiliation: Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands
name: Victor E. Staartjes, MSIII
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19.
citation: Staartjes VE, Klukowska AM, Schroder ML. Association of maximum back and leg pain severity with objective functional impairment as assessed by five-repetition sit-to-stand testing: analysis of two prospective studies. Neurosurg Rev. 2020 Oct;43(5):1331-1338. doi: 10.1007/s10143-019-01168-3. Epub 2019 Aug 26.
citation: Staartjes VE, Beusekamp F, Schroder ML. Can objective functional impairment in lumbar degenerative disease be reliably assessed at home using the five-repetition sit-to-stand test? A prospective study. Eur Spine J. 2019 Apr;28(4):665-673. doi: 10.1007/s00586-019-05897-3. Epub 2019 Jan 24.