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| Name | Class |
|---|---|
| PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich | UNKNOWN |
| PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentral-schweiz, Luzern | UNKNOWN |
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The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).
The purposes of the study is to assess the ability of the 6-Minute Walking Test (6MWT) as a reliable and standardized objective outcome assessment and its relation to already established subjective patient reported outcome measures in patients suffering from lumbar degenerative disc disease. We want to use an existing smartphone-application that uses global positioning system (GPS) coordinates to measure walking distance. Applying self- measurement of the 6MWT before and after a therapeutic intervention, we determine objective functional impairment (OFI) in patients. The results of this study add to the understanding of achievable objective outcomes after therapeutic interventions applied to patients with DDD and examines patients acceptance for smartphone based self-measurement.
Primary Objectives The primary objective is to determine the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD)
Secondary objectives are
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDD Patients | All patients presenting to the neurosurgical department of the Kantonsspital St. Gallen (KSSG) with a diagnosed DDD fulfilling the inclusion criteria and scheduled for surgery will be considered for this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Raw walking distance | Raw walking distance (in m), as measured with the 6MWT, between the baseline- (before surgery) and follow-up assessment | 4-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| TTFS | Difference in Time to First Symptoms (TTFS; in sec) as measured by the 6MWT, between the baseline- and follow-up assessment | 4-12 weeks |
| DTFS | Difference in Distance to First Symptoms (DTFS, in m), as measured by the 6MWT, between the baseline- and follow-up assessment |
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Inclusion Criteria:
Exclusion Criteria:
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All patients presenting to the neurosurgical department of the Kantonsspital St. Gallen (KSSG) with a diagnosed DDD fulfilling the inclusion criteria and scheduled for surgery will be considered for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Nicolai Maldaner, MD | Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital St. Gallen / Department of Neurosurgery | Sankt Gallen | Canton of St. Gallen | 9000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37182704 | Derived | Ziga M, Sosnova M, Zeitlberger AM, Regli L, Bozinov O, Weyerbrock A, Ratliff JK, Stienen MN, Maldaner N. Objective outcome measures may demonstrate continued change in functional recovery in patients with ceiling effects of subjective patient-reported outcome measures after surgery for lumbar degenerative disorders. Spine J. 2023 Sep;23(9):1314-1322. doi: 10.1016/j.spinee.2023.05.002. Epub 2023 May 13. | |
| 35015137 |
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| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 4-12 weeks |
| Zurich Claudication Questionnaire (ZCQ) | Difference in PROM, as measured by the Zurich Claudication Questionnaire (ZCQ average score, range 0 (best) - 4,5 (worst), between the baseline- and follow-up assessment. | 4-12 weeks |
| Core Outcome Measures Index (COMI) | Difference in health-related quality of life (hrQoL), as measured by the Core Outcome Measures Index (COMI average score, range 0 (best) - 10 (worst)), between the baseline- and follow-up assessment | 4-12 weeks |
| TTFS/ZCQ baseline | Correlation of TTFS/DTFS in the 6MWT with the ZCQ score at baseline | 4-12 weeks |
| TTFS/ZCQ follow-up | Correlation of TTFS in the 6MWT with the ZCQ score at follow-up | 4-12 weeks |
| TTFS/COMI baseline | Correlation of TTFS/DTFS in the 6MWT with the COMI score at baseline | 4-12 weeks |
| TTFS/COMI follow-up | Correlation of TTFS/DTFS in the 6MWT with the COMI score at follow-up | 4-12 weeks |
| TTFS/TUG baseline | Correlation of TTFS/DTFS in the 6MWT with the Timed up go Test (TUG) at baseline | 4-12 weeks |
| TTFS/TUG follow-up | Correlation of TTFS/DTFS in the 6MWT with the TUG at follow-up | 4-12 weeks |
| Test-retest reliability of the 6MWT | Test-retest reliability of the 6MWT in patients with lumbar degenerate disc disease, tested two consecutive times with the 6MWT App (within 3 days) before as well as after surgery. | 6 weeks to 1 day before surgery as well as 4-12 weeks after surgery |
| Derived |
| Zeitlberger AM, Sosnova M, Ziga M, Gautschi OP, Regli L, Bozinov O, Weyerbrock A, Stienen MN, Maldaner N. Distance to first symptoms measured by the 6-min walking test differentiates between treatment success and failure in patients with degenerative lumbar disorders. Eur Spine J. 2022 Mar;31(3):596-603. doi: 10.1007/s00586-021-07103-9. Epub 2022 Jan 11. |
| 34042414 | Derived | Zeitlberger AM, Sosnova M, Ziga M, Regli L, Bozinov O, Weyerbrock A, Stienen MN, Maldaner N. Assessment of the Minimum Clinically Important Difference in the Smartphone-based 6-minute Walking Test After Surgery for Lumbar Degenerative Disc Disease. Spine (Phila Pa 1976). 2021 Sep 15;46(18):E959-E965. doi: 10.1097/BRS.0000000000003991. |
| 34033596 | Derived | Maldaner N, Sosnova M, Ziga M, Zeitlberger AM, Bozinov O, Gautschi OP, Weyerbrock A, Regli L, Stienen MN. External Validation of the Minimum Clinically Important Difference in the Timed-up-and-go Test After Surgery for Lumbar Degenerative Disc Disease. Spine (Phila Pa 1976). 2022 Feb 15;47(4):337-342. doi: 10.1097/BRS.0000000000004128. |
| 33974372 | Derived | Maldaner N, Sosnova M, Zeitlberger AM, Ziga M, Gautschi OP, Regli L, Bozinov O, Weyerbrock A, Stienen MN. Responsiveness of the self-measured 6-minute walking test and the Timed Up and Go test in patients with degenerative lumbar disorders. J Neurosurg Spine. 2021 May 7;35(1):52-59. doi: 10.3171/2020.11.SPINE201621. Epub 2021 May 7. |