Post-Stroke Osteopathy

Completed

• Conditions: Fall; Fracture; Stroke (CVA) or TIA

• Registration Number: NCT04845269
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-31
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with and without fractures	12 months

Trial Locations

Locations (1)

Medical University of Innsbruck, Department of Neurology; 🇦🇹 Innsbruck, Austria