Lumbar Spinal Stenosis Clinical Trial
— 6MWT-DDDOfficial title:
The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
NCT number | NCT03977961 |
Other study ID # | 6MWT DDD - 1.0 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | May 1, 2020 |
Verified date | July 2022 |
Source | Cantonal Hospital of St. Gallen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).
Status | Completed |
Enrollment | 50 |
Est. completion date | May 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient scheduled for spine surgery with one of the following diagnosis (1) lumbar disc herniation (LDH), (2) lumbar spinal stenosis lumbar (LSS) or lumbar DDD with or without instability requiring lumbar fusion (transforaminal lumbar interbody fusion, posterior lumbar interbody fusion, or extreme lateral interbody fusion) - Male and Female subjects = 18 years - Written informed consent Exclusion Criteria: - Pregnancy - Inability to walk (extreme pain or severe neurological deficits) - Severe Chronic Obstructive Lung Disease (COPD) corresponding to = Gold III - Severe heart failure corresponding to = New York Heart Association (NYHA) III - Lung cancer and diffuse parenchymal lung disease - Other medical reasons interfering with the patient's ability to walk and perform the 6MWT (e.g., osteoarthritis disease of the lower extremities, Parkinson's disease, heart failure, hip or knee prosthesis etc.) - Unavailability for follow up and/or inability to complete assessment (planning to move, no smartphone, etc.). |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kantonsspital St. Gallen / Department of Neurosurgery | St. Gallen | Saint Gallen |
Lead Sponsor | Collaborator |
---|---|
Cantonal Hospital of St. Gallen | Dr. med. Peter Prömmel, Klinik für Neurochirurgie, Kantonsspital St. Gallen, med. pract. Markéta Sosnová, Klinik für Neurochirurgie, Kantonsspital St. Gallen, PD Dr. med. Martin Stienen, Klinik für Neurochirurgie, Universitätsspital Zürich, PD Dr. med. Oliver Gautschi, Neuro- und Wirbelsäulen Zentrum Zentral-schweiz, Luzern, Prof. Dr. Astrid Weyerbrock, Klinik für Neurochirurgie, Kantonsspital St. Gallen |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | DTFS | Difference in Distance to First Symptoms (DTFS, in m), as measured by the 6MWT, between the baseline- and follow-up assessment | 4-12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | TTFS/ZCQ baseline | Correlation of TTFS/DTFS in the 6MWT with the ZCQ score at baseline | 4-12 weeks | |
Secondary | TTFS/ZCQ follow-up | Correlation of TTFS in the 6MWT with the ZCQ score at follow-up | 4-12 weeks | |
Secondary | TTFS/COMI baseline | Correlation of TTFS/DTFS in the 6MWT with the COMI score at baseline | 4-12 weeks | |
Secondary | TTFS/COMI follow-up | Correlation of TTFS/DTFS in the 6MWT with the COMI score at follow-up | 4-12 weeks | |
Secondary | TTFS/TUG baseline | Correlation of TTFS/DTFS in the 6MWT with the Timed up go Test (TUG) at baseline | 4-12 weeks | |
Secondary | TTFS/TUG follow-up | Correlation of TTFS/DTFS in the 6MWT with the TUG at follow-up | 4-12 weeks | |
Secondary | 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 |
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