Post-Stroke Osteopathy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04845269

Enrollment

127

Registered

2021-04-14

Start date

2021-03-31

Completion date

2023-05-31

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall, Fracture, Stroke (CVA) or TIA

Keywords

high-resolution peripheral quantitative Computer Tomography, Bone microstructure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Number of patients with and without fractures	12 months

Other

Measure	Time frame	Description
Changes in imaging bone structure between the baseline and follow-up in all extremities as measured by quantitative CT imaging	12 months	—
Number and circumstances (housing situation, concomitant medication, level of immobility,...) of falls between baseline and one-year follow-up	12 months	Due to the observational nature of the study, these outcome parameters will be published with descriptive statistics
Change in blood bone biomarkers (as mentioned before) between baseline and follow-up	12 months	CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin, RANKL-OPG-Ratio
Circumstances (housing situation, concomitant medication, level of immobility,...) of fractures during the twelve-month follow up	12 months	—

Countries

Austria

Outcome results