Post-Stroke Osteopathy
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ClinicalTrials.gov Identifier: NCT04845269 |
Recruitment Status :
Active, not recruiting
First Posted : April 14, 2021
Last Update Posted : June 24, 2022
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Tracking Information | |||||
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First Submitted Date | April 7, 2021 | ||||
First Posted Date | April 14, 2021 | ||||
Last Update Posted Date | June 24, 2022 | ||||
Actual Study Start Date | March 31, 2021 | ||||
Estimated Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Number of patients with and without fractures [ Time Frame: 12 months ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title | Post-Stroke Osteopathy | ||||
Official Title | Post-Stroke Osteopathy: Characterization of Fractures and Changes in the Bone Microstructure After Ischemic Stroke or TIA | ||||
Brief Summary | The sudden biomechanical inactivation, direct neuro-humoral effects and sustained systemic stress reaction, which commonly occur after stroke or TIA, all may be of relevance in triggering alterations in bone metabolism and remodelling of bone microstructure. The objectives of this observational pilot study are to characterize falls and fractures and their circumstances (sex and age specific incidence, time course, risk conditions, localization) in ischemic stroke patients, study changes in the bone microstructure after ischemic stroke supported by high-resolution peripheral quantitative Computer Tomography, unravel a molecular mechanisms underlying the increased fracture risk (focus on Wnt-signaling and ß-adrenergic projection), establish risk factors to estimate the risk of falls based on information from gait analysis as well as construct deep learning algorithms to identify bone microstructure parameters for predicting fractures. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description: CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin, RANKL-OPG-Ratio
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Sampling Method | Non-Probability Sample | ||||
Study Population | As a sub-study of the STROKE-CARD Registry Study the source population will be all patients treated at the Department of Neurology Innsbruck (Austria) for stroke and included in the STROKE-CARD Registry Study. The target study population for the Post-Stroke Osteopathy Study will be all patients included in the STROKE-CARD Registry Study (clinicaltrials.gov ID NCT04582825). | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
127 | ||||
Original Estimated Enrollment |
200 | ||||
Estimated Study Completion Date | May 31, 2023 | ||||
Estimated Primary Completion Date | May 31, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 60 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Austria | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04845269 | ||||
Other Study ID Numbers | VASC-E3-2020-06 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | VASCage GmbH | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | VASCage GmbH | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Medical University Innsbruck | ||||
Investigators |
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PRS Account | VASCage GmbH | ||||
Verification Date | June 2022 |