Post-Stroke Osteopathy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04845269 |
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Recruitment Status :
Active, not recruiting
First Posted : April 14, 2021
Last Update Posted : June 24, 2022
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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.
| Condition or disease |
|---|
| Stroke (CVA) or TIA Fracture Fall |
| Study Type : | Observational |
| Actual Enrollment : | 127 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Post-Stroke Osteopathy: Characterization of Fractures and Changes in the Bone Microstructure After Ischemic Stroke or TIA |
| Actual Study Start Date : | March 31, 2021 |
| Estimated Primary Completion Date : | May 31, 2023 |
| Estimated Study Completion Date : | May 31, 2023 |
- Number of patients with and without fractures [ Time Frame: 12 months ]
- Changes in imaging bone structure between the baseline and follow-up in all extremities as measured by quantitative CT imaging [ Time Frame: 12 months ]
- Number and circumstances (housing situation, concomitant medication, level of immobility,...) of falls between baseline and one-year follow-up [ Time Frame: 12 months ]Due to the observational nature of the study, these outcome parameters will be published with descriptive statistics
- Change in blood bone biomarkers (as mentioned before) between baseline and follow-up [ Time Frame: 12 months ]CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin, RANKL-OPG-Ratio
- Circumstances (housing situation, concomitant medication, level of immobility,...) of fractures during the twelve-month follow up [ Time Frame: 12 months ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Inclusion in the STROKE-CARD Registry Study
- Modified Rankin Scale (mRS) < 5
- Provision of signed and dated informed consent form
- Willingness to comply with all study procedures and ability to participate in the study over the complete study duration
Exclusion Criteria:
- Persistent motor deficit before the onset event
- Not able to walk without walking aid or not able to put the full bodyweight on either leg before the onset event
- Medical history of stroke
- Premedication with Corticosteroids for more than 6 Weeks or Pioglitazone or Bisphosphonate within the last 12 months
- Limb amputation
- BMI < 18,5 kg/m2 or > 35 kg/m2
- Present or previous fracture in the distal Radius or Tibia interfering with HR-pQCT
- Movement disorder interfering with HR-pQCT imaging
- Women of childbearing potential
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): NCT04845269
| Austria | |
| Medical University of Innsbruck, Department of Neurology | |
| Innsbruck, Austria, 6020 | |
| Principal Investigator: | Michael Knoflach, Assoz.Prof. Priv.-Doz. Dr. | Medical University of Innsbruck, Department of Neurology |
Publications:
| Responsible Party: | VASCage GmbH |
| ClinicalTrials.gov Identifier: | NCT04845269 |
| Other Study ID Numbers: |
VASC-E3-2020-06 |
| First Posted: | April 14, 2021 Key Record Dates |
| Last Update Posted: | June 24, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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high-resolution peripheral quantitative Computer Tomography Bone microstructure |
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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |