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Clinical Trials/NCT06842758
NCT06842758
Active, not recruiting
Not Applicable

Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures

University of Palermo1 site in 1 country40 target enrollmentStarted: May 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
40
Locations
1
Primary Endpoint
Degree of Hyperkyphosis

Overview

Brief Summary

Multiple vertebral fragility fractures, one of the main complications of osteoporosis, are frequently associated with thoracic hyperkyphosis, which in turn leads to significant postural alterations.

These biomechanical changes may increase fall risk, posing a critical clinical issue for elderly patients. However, the results of studies investigating the association between hyperkyphosis and fall risk are conflicting, highlighting the need for further research.

This study aims to explore the correlation between the severity of thoracic kyphotic curvature and fall risk in patients with multiple fragility fractures undergoing osteoporosis treatment.

Additionally, the study seeks to evaluate the role of physiotherapy in improving patients' functional and postural outcomes.

A retrospective observational study was conducted, supplemented by a narrative literature review to contextualize the findings. Forty patients undergoing treatment at the Functional Recovery and Rehabilitation Unit (UOC) of P. Giaccone University Hospital in Palermo were enrolled and followed up via biannual phone interviews. Data were collected between May 2023 and May 2024, with a longitudinal assessment of outcomes from T0 (baseline) to T1 (12 months).

The severity of the kyphotic curve was quantified using the Cobb method, while fall risk was assessed through the Berg Balance Scale. Participation in physiotherapy programs was analyzed to evaluate their impact on clinical and functional outcomes.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women aged ≥65 years.
  • Presence of at least three documented vertebral fragility fractures.
  • Diagnosis of thoracic hyperkyphosis

Exclusion Criteria

  • History of orthopedic surgeries involving the spine or lower limbs.
  • Treatments for cerebrovascular diseases.
  • Presence of balance disorders.
  • Active oncological diseases.
  • Use of walking aids

Outcomes

Primary Outcomes

Degree of Hyperkyphosis

Time Frame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Cobb's method by 2p radiographic examination of the whole spine

Number of falls in the last year

Time Frame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Evaluation of the number of falls in the last year

Balance

Time Frame: At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);

Assessment of balance by means of the Berg Scale

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof.ssa Giulia Letizia Mauro

Professor

University of Palermo

Study Sites (1)

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