Clinical trial NCT05207748: The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients
Official title: The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Patients
Keywords: stroke
osteoporosis
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 44 patients

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.

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

Primary outcomes:
measure: Bone mineral density
timeFrame: baseline
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: baseline
measure: Functional Ambulation Classification
timeFrame: baseline
measure: Timed up and go test
timeFrame: baseline
measure: Falls Self-Efficacy Scale
timeFrame: baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
References: