Post-Stroke Osteopathy

VASCage

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04845269

VASC-E3-2020-06

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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