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Clinical Trials/NCT05207748
NCT05207748
Completed
Not Applicable

The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 site in 1 country44 target enrollmentJanuary 27, 2022
ConditionsStroke Patients

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Patients
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Enrollment
44
Locations
1
Primary Endpoint
Bone mineral density
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

Detailed Description

Improving balance function is considered as an important method for reducing the risk of falling after stroke and protecting bone health. Bone mineral density, a measure of bone health, has been reported to decrease after stroke, consistent with increased bone resorption and decreased bone formation. The aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

Registry
clinicaltrials.gov
Start Date
January 27, 2022
End Date
November 20, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tuğba Atan, MD

Assoc. Prof

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients ≥ 50 and ≤ 75 years old
  • Patients with a 10-year risk of hip fracture ≥3%, major osteoporotic fracture risk ≥20% according to the Fracture Risk Assessment Tool, FRAX, scoring
  • Patients with unilateral hemiplegia as a result of first-time stroke (onset time \> 3 months)
  • Patients who can stand for at least 2 minutes independently/under supervision for measurements while standing, and who can walk at least 10 meters independently/under supervision with or without walking aid for measurements taken while walking
  • Patients whose cognitive status is able to understand the study instructions (Mini-Mental State Assessment score ≥ 23)
  • Patients with stable medical and psychological status
  • Patients willing to participate in the study

Exclusion Criteria

  • Patients with serious cardiovascular or musculoskeletal problems that prevent walking
  • Patients with severe vision, hearing and language problems
  • Patients with other neurological (Parkinson's, epilepsy, meningitis, cerebellar disease, vertigo, dizziness, polyneuropathy, etc.) or musculoskeletal (severe low back pain, knee problems) diseases that may affect balance performance other than stroke.
  • Patients with peripheral vascular disease

Outcomes

Primary Outcomes

Bone mineral density

Time Frame: baseline

Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method.

Secondary Outcomes

  • Berg Balance Scale(baseline)
  • Timed up and go test(baseline)
  • Falls Self-Efficacy Scale(baseline)
  • Functional Ambulation Classification(baseline)

Study Sites (1)

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