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CompletedNCT033213575RSTS-2Updated Jul 13, 2018

Retest-reliability and At-home-assessment Feasibility of the 5R-STS

An observational study in Degenerative Disc Disease, Spondylolisthesis and Spondylosis, sponsored by Bergman Clinics. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2018-07-13.

Sponsored by Bergman Clinics · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Intervertebral Disc Degeneration with a site in Netherlands — none open to participants now, none under way, none of them phase 3. Intervertebral Disc Degeneration · Netherlands.

Started
2017
with 1 other
Observational
5 of 10
none open now
Registered
8th of 10
by date
Lead sponsor
1 of 10
Bergman Clinics

Among the 10 studies in Intervertebral Disc Degeneration with a site in Netherlands, this one is one of 2 that started in 2017, is one of 5 observational ones, and was the 8th registered.

Intervertebral Disc Degeneration

462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.

Browse Intervertebral Disc Degeneration studies →

Open to participants now

None of the 10 studies in Intervertebral Disc Degeneration with a site in Netherlands is open now.

Who these studies take

Of the 60 Intervertebral Disc Degeneration studies recruiting now, 29 (48%) set no upper age limit and 16 (27%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 10 studies in Intervertebral Disc Degeneration with a site in Netherlands as a file.
02

Study 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.

Read the 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)
03

Conditions studied

  • Degenerative Disc Disease
  • Spondylolisthesis
  • Spondylosis
  • Herniated Nucleus Pulposus
  • Spinal Stenosis Lumbar
  • Spinal Diseases
  • Spinal Instability
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with symptomatic degenerative diseases of the lumbar spine that come in for surgical treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Hip or Knee prosthetics
  • Walking aides
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testfive-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.

    Also known as: 5R-STS

06

What researchers measure

Primary outcomes

  1. 5R-STS

    Objective functional test measuring the amount of functional impairment.

    Time frame: 0 months

Secondary outcomes

  1. EQ-5D-3L

    Validated questionnaire measuring quality of life

    Time frame: 0 months

  2. Oswestry Disability Index

    Validated questionnaire measuring functional disability

    Time frame: 0 months

  3. VAS leg pain severity

    Validated questionnaire measuring pain

    Time frame: 0 months

  4. VAS back pain severity

    Validated questionnaire measuring pain

    Time frame: 0 months

  5. Roland Morris Disability Questionnaire

    Validated questionnaire measuring functional disability

    Time frame: 0 months

07

Study locations

1 site
  • Bergman Clinics
    Naarden, 1411 GE, Netherlands
08

References and documents

Publications

  • 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. PubMed 23783372 ↗
  • 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. PubMed 31451936 ↗
  • 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. PubMed 30680635 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jun 2018, 5 months.

Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2017
First posted
Oct 25, 2017
StartActual
Dec 8, 2017
Primary completionActual
Jun 1, 2018
CompletionActual
Jun 21, 2018
Last update
Jul 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03321357
Lead sponsor
Bergman Clinics
Responsible party
Marc Schröder (MD, PhD, Bergman Clinics) — Principal investigator
First posted
Oct 25, 2017
Start date
Dec 8, 2017
Primary completion
Jun 1, 2018
Completion
Jun 21, 2018
Last update
Jul 13, 2018

Study contacts

Victor E. Staartjes, MSIII
principal investigator · Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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