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Trial record 12 of 148 for:    "Spondylolysis"

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
Sponsor:
Information provided by (Responsible Party):
Marc Schröder, Bergman Clinics

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.


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

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)

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 5R-STS [ Time Frame: 0 months ]
    Objective functional test measuring the amount of functional impairment.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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
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

Information from the National Library of Medicine

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


Locations
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Netherlands
Bergman Clinics
Naarden, Netherlands, 1411 GE
Sponsors and Collaborators
Bergman Clinics
Investigators
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Principal Investigator: Victor E. Staartjes, MSIII Department of Neurosurgery, Bergman Clinics, Naarden, The Netherlands

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marc Schröder, MD, PhD, Bergman Clinics
ClinicalTrials.gov Identifier: NCT03321357     History of Changes
Other Study ID Numbers: 5R-STS-2
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis