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Trial record 1 of 1 for:    post-stroke osteopathy
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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

Tracking Information
First Submitted Date April 7, 2021
First Posted Date April 14, 2021
Last Update Posted Date April 14, 2021
Actual Study Start Date March 31, 2021
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2021)
Number of patients with and without fractures [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 13, 2021)
  • 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 ]
  • Change in blood bone biomarkers (as mentioned before) between baseline and follow-up [ Time Frame: 12 months ]
  • Circumstances (housing situation, concomitant medication, level of immobility,...) of fractures during the twelve-month follow up [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
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
  • Stroke (CVA) or TIA
  • Fracture
  • Fall
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 13, 2021)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Benjamin Dejakum, Dr. +43 512 50 83810 benjamin.dejakum@vascage.at
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party VASCage GmbH
Study Sponsor VASCage GmbH
Collaborators Medical University Innsbruck
Investigators
Principal Investigator: Michael Knoflach, Assoz.Prof. Priv.-Doz. Dr. Medical University of Innsbruck, Department of Neurology
PRS Account VASCage GmbH
Verification Date April 2021