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

Completed

• Conditions: Stroke Patients
• Interventions: Diagnostic Test: Bone mineral density

• Registration Number: NCT05207748
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2022-01-27
• Primary Completion: 2022-11-20
• Study Completion: 2022-11-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with a history of falls	Bone mineral density	Demographic characteristics and medical histories (age, height, weight, smoking, alcohol use, comorbidities, medications, stroke onset date, stroke side, total number of rehabilitation received, assistive device use, history of falls) of all patients participating in the study will be recorded. Detailed physical examinations (mini-mental status assessment, brunstrum stages, spasticity assessments, orthosis use) will be performed. Berg Balance Scale, which will reveal the balance states; Functional ambulation scores and Timed Up and Go test will be applied to determine their functional status. In addition, the International Fall Efficiency Scale questionnaire will be administered. Bone mineral density will be evaluated to assess patients' bone health.
patients without a history of falls	Bone mineral density	Demographic characteristics and medical histories (age, height, weight, smoking, alcohol use, comorbidities, medications, stroke onset date, stroke side, total number of rehabilitation received, assistive device use, history of falls) of all patients participating in the study will be recorded. Detailed physical examinations (mini-mental status assessment, brunstrum stages, spasticity assessments, orthosis use) will be performed. Berg Balance Scale, which will reveal the balance states; Functional ambulation scores and Timed Up and Go test will be applied to determine their functional status. In addition, the International Fall Efficiency Scale questionnaire will be administered. Bone mineral density will be evaluated to assess patients' bone health.

Primary Outcome Measures

Name	Time	Method
Bone mineral density	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 Outcome Measures

Name	Time	Method
Berg Balance Scale	baseline	The Berg Balance Scale is a widely used clinical test that can reveal a person's static and dynamic balance abilities. Total test score range from 0 (lowest balance) to 56 (highest balance) ability.
Timed up and go test	baseline	The timed up and go test is a test used to evaluate mobility, balance, and walking in people with balance disorders.
Falls Self-Efficacy Scale	baseline	The International Fall Activity Scale is a scale that examines an individual's concerns about the possibility of falling during 16 different activities that do not threaten daily life.The response option ranged from 1-4 depicted by 1 for being not at all concerned, 2 for being somewhat concerned, 3 for being fairly concerned and 4 for being very concerned.
Functional Ambulation Classification	baseline	The Functional Ambulation Classification is a functional walking test that evaluates ambulation ability. It includes six different categories and assesses ambulation status by determining how much support the patient needs while walking, regardless of whether they use assistive devices.

Trial Locations

Locations (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey