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

NCT05207748 | Completed

• 1 other identifier: E1/1026/2020
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Patients

Keywords

stroke; osteoporosis

Outcome Measures

Primary Outcomes (1)

• Bone mineral density

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

  baseline

Secondary Outcomes (4)

• Berg Balance Scale

  baseline

• Functional Ambulation Classification

  baseline

• Timed up and go test

  baseline

• Falls Self-Efficacy Scale

  baseline

Study Arms (2)

patients with a history of falls

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.

Diagnostic Test: Bone mineral density

patients without a history of falls

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.

Diagnostic Test: Bone mineral density

Interventions

Bone mineral density DIAGNOSTIC_TEST

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

patients with a history of falls; patients without a history of falls

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

44 patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Osteoporosis

Interventions

Bone Density

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 26, 2022
• Study Start: January 27, 2022
• Primary Completion: November 20, 2022
• Study Completion: November 20, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

TU (1)