The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method.
|
|
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. |
Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: 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.
|
baseline
|
|
Functional Ambulation Classification
Time Frame: 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.
|
baseline
|
|
Timed up and go test
Time Frame: baseline
|
The timed up and go test is a test used to evaluate mobility, balance, and walking in people with balance disorders.
|
baseline
|
|
Falls Self-Efficacy Scale
Time Frame: 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.
|
baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1/1026/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.