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NCT Number: NCT04845269

Post-Stroke Osteopathy

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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Key information

Conditions

Stroke (CVA) or TIA Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Fall Fracture Fractures, Bone Nervous System Diseases Stroke Vascular Diseases Wounds and Injuries

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck, Department of Neurology

Innsbruck, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with and without fractures

    Time frame: 12 months

Other outcomes

  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

    Due to the observational nature of the study, these outcome parameters will be published with descriptive statistics

  3. 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

  4. Circumstances (housing situation, concomitant medication, level of immobility,...) of fractures during the twelve-month follow up

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

VASCage GmbH

Other

Collaborators

  • Medical University Innsbruck

Registry information

Official study title

Post-Stroke Osteopathy: Characterization of Fractures and Changes in the Bone Microstructure After Ischemic Stroke or TIA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2021
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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