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Completed

NCT Number: NCT03321357

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

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Herniated Nucleus Pulposus Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spinal Instability Spinal Stenosis Lumbar Spondylolisthesis Spondylolysis Spondylosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Bergman Clinics

Naarden, 1411 GE, Netherlands

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

five-repetition sit-to-stand test

Diagnostic 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 names: 5R-STS

Primary outcomes

  1. 5R-STS

    Time frame: 0 months

    Objective functional test measuring the amount of functional impairment.

Secondary outcomes

  1. EQ-5D-3L

    Time frame: 0 months

    Validated questionnaire measuring quality of life

  2. Oswestry Disability Index

    Time frame: 0 months

    Validated questionnaire measuring functional disability

  3. VAS leg pain severity

    Time frame: 0 months

    Validated questionnaire measuring pain

  4. VAS back pain severity

    Time frame: 0 months

    Validated questionnaire measuring pain

  5. Roland Morris Disability Questionnaire

    Time frame: 0 months

    Validated questionnaire measuring functional disability

Sponsors and collaborators

Lead sponsor

Bergman Clinics

Other

Registry information

Official study title

Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)

Acronym: 5RSTS-2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2017
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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