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Post-Stroke Osteopathy

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ClinicalTrials.gov Identifier: NCT04845269
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
VASCage GmbH

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.


Condition or disease
Stroke (CVA) or TIA Fracture Fall

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Study Type : Observational
Estimated Enrollment : 200 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 : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures




Primary Outcome Measures :
  1. Number of patients with and without fractures [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Changes in imaging bone structure between the baseline and follow-up in all extremities as measured by quantitative CT imaging [ Time Frame: 12 months ]
  2. Number and circumstances (housing situation, concomitant medication, level of immobility,...) of falls between baseline and one-year follow-up [ Time Frame: 12 months ]
  3. Change in blood bone biomarkers (as mentioned before) between baseline and follow-up [ Time Frame: 12 months ]
  4. 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
CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin, RANKL-OPG-Ratio


Information from the National Library of Medicine

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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
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).
Criteria

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

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): NCT04845269


Contacts
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Contact: Benjamin Dejakum, Dr. +43 512 50 83810 benjamin.dejakum@vascage.at

Locations
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Austria
Medical University of Innsbruck, Department of Neurology Recruiting
Innsbruck, Austria, 6020
Contact: Benjamin Dejakum, Dr.    +43 512 50 83810    benjamin.dejakum@vascage.at   
Sponsors and Collaborators
VASCage GmbH
Medical University Innsbruck
Investigators
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Principal Investigator: Michael Knoflach, Assoz.Prof. Priv.-Doz. Dr. Medical University of Innsbruck, Department of Neurology
Publications:

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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: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VASCage GmbH:
high-resolution peripheral quantitative Computer Tomography
Bone microstructure
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases