Stroke PatientsNCT05207748
The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients
An observational study of Stroke Patients, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- Bone mineral density
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2022to 20 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 44 patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
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.
Read the 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.
- Conditions
- Stroke Patients
- Being tested
- Bone mineral density
- Keywords
- stroke, osteoporosis
- Medical subject headings
- Stroke, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone mineral densityDiagnostic test
Bone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Bone mineral density |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (4)
Berg Balance Scale
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.
Measured: baseline
Functional Ambulation Classification
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.
Measured: baseline
Timed up and go test
The timed up and go test is a test used to evaluate mobility, balance, and walking in people with balance disorders.
Measured: baseline
Falls Self-Efficacy Scale
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start27 Jan 2022
- Primary completion20 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207748
- Sponsor's protocol ID
- E1/1026/2020
- Status last verified
- May 2024
- First submitted
- 29 Dec 2021
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Bone Mineral Density With Balance, Functional Ambulation and Falls in Stroke Patients
- ClinicalTrials.gov ID
- NCT05207748
- Acronym / sponsor ID
- E1/1026/2020
- Conditions
- Stroke Patients
- Keywords
- stroke, osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with a history of falls | – | Diagnostic Test: Bone mineral densityDemographic 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 | – | Diagnostic Test: Bone mineral densityDemographic 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 44 patients
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone mineral densityBone mineral density (BMD) will be measured on the lumbar spine (L1-L4) and femoral neck by dual X-ray absorptiometry (DXA) method. | Diagnostic test | patients with a history of falls, patients without a history of falls |
Primary outcome
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.
4 secondary outcomes
Berg Balance Scale
Time frame: baseline
Functional Ambulation Classification
Time frame: baseline
Timed up and go test
Time frame: baseline
Falls Self-Efficacy Scale
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Patients, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.