StrokeNCT06646003
Reference Values and Determinants of 6-minute Walk Test
An observational study of Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The first aim of this study was to investigate the reference values of 6-minute walk test (6MWT) distance in patients with chronic stroke. The second aim was to determine the factors predicting 6MWT distance in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Evaluation of 6-minute walking distance and related factors in patients with chronic stroke
- How many people
- 341 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 25 Nov 2025
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: patients with chronic stroke
Who may be able to join
- Having first ever stroke
- The time elapsed after the stroke is more than 6 months and less than 10 years
- 18-80 years old
- Those who could walk independently with no assistance or device and who could walk with an intermittent or continuous light touch to assist balance or coordination
Who cannot join
- A history of severe musculoskeletal, cardiopulmonary, or psychiatric disease that can inhibit measurements
- Patients who had received a neurologic diagnosis other than stroke, such as Parkinson's disease or multiple sclerosis
- Patients with impaired level of consciousness and evidence of gross cognitive impairment (Scored below 10 points in the Mini-Mental State Examination
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: Reference Values and Determinants of 6-minute Walk Test Distance in Turkish Patients With Chronic Stroke: A Multicenter Cross-sectional Study
The first aim of this study was to investigate the reference values of 6-minute walk test (6MWT) distance in patients with chronic stroke. The second aim was to determine the factors predicting 6MWT distance in patients with chronic stroke.
Read the detailed description
There may be large variations in the distance of 6MWT according to the stroke severity. Investigation of factors related to 6MWT may be helpful in determining and targeting appropriate strategies for gait rehabilitation. Accordingly, the first aim of this study was to investigate the reference values of 6-minute walk test (6MWT) distance in patients with chronic stroke. The second aim was to determine the factors predicting 6MWT distance in patients with chronic stroke.
- Conditions
- Stroke
- Being tested
- Evaluation of 6-minute walking distance and related factors in patients with chronic stroke
- Keywords
- walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of 6-minute walking distance and related factors in patients with chronic strokeOther
Evaluation of 6-minute walking distance and related factors in patients with chronic stroke.
| Study group | Role | What they receive |
|---|---|---|
| stroke group | patients with chronic stroke Receives: Other: Evaluation of 6-minute walking distance and related factors in patients with chronic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test (6MWT)
6MWT will be used to evaluate the walking endurance. A 30-m indoor walkway will be used to conduct the test. The maximal distance covered at the end of the 6MWT will be recorded.
Measured: through study completion, an average of one month
Secondary outcomes (8)
Functional ambulation scale (FAC)
Patients will be classified by walking ability using FAC has six levels (0 to 5) that are classified according to the walking ability on the basis of the amount of physical support required, which are as follows: nonfunctional ambulatory(FAC 0); ambulatory, continuous manual contact to support body weight as well as to maintain balance or to assist coordination (FAC 1); ambulatory [level I], intermittent or continuous light touch to assist balance or coordination (FAC 2); ambulatory, dependent on supervision (FAC 3); ambulatory, independent, level surface only (FAC 4); and ambulatory, independent (FAC 5).
Measured: through study completion, an average of one month
Brunnstrom motor recovery staging
Upper extremity, hand and lower extremity motor recovery will be assessed using the Brunnstrom 6 sequential stages of motor recovery.
Measured: through study completion, an average of one month
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale will be used to measure the severity of knee extensor, knee flexor and ankle plantar flexor spasticity. MAS scores will be added together to give a total MAS score. MAS is graded from 0 to 4. A score of 0 indicates no increase at all in muscle tone, and 4 indicates that the joint is rigid in flexion or extension.
Measured: through study completion, an average of one month
Beck depression inventory (BDI)
The beck depression inventory (BDI) will be used to evaluate depression. The BDI consists of 21 questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answers, ranging in intensity. A value of 0-3 is assigned for each answer, and the total score is compared with a key to determine the severity of depression .The standard cut off values are as follows: 0-9, minimal depression; 10-18, mild depression; 19-29, moderate depression; and 30-63, severe depression.
Measured: through study completion, an average of one month
Mini-mental state examination (MMSE)
The mini-mental state examination will be used to describe mental and cognitive functions.
Measured: through study completion, an average of one month
Star cancellation test
Star cancellation test will be used to describe neglect phenomenon.
Measured: through study completion, an average of one month
Barthel Index
Activities of daily living (ADL) will be assessed using the Barthel Index. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically ADL and mobility. The items include feeding, bathing, grooming, dressing, toileting, transferring, walking on a level surface, going up and down stairs, and continence of bowel and bladder. A patient with a maximum score of 100 points is defined as continent, able to eat and dress independently, able to walk at least a block, and able to go up and down stairs.
Measured: through study completion, an average of one month
Berg Balance Scale (BBS)
Balance ability will be tested using the Berg Balance Scale (BBS), which includes 14 functional balance items, with scores ranging from 0 to 56 points; better balance is indicated by a higher score.
Measured: through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start30 Nov 2024
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 341 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, Merve Örücü Atar, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646003
- Sponsor's protocol ID
- 1-24-599
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values and Determinants of 6-minute Walk Test Distance in Turkish Patients With Chronic Stroke: A Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06646003
- Acronym / sponsor ID
- 1-24-599
- Conditions
- Stroke
- Keywords
- walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 17 Oct 2024 (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 first aim of this study was to investigate the reference values of 6-minute walk test (6MWT) distance in patients with chronic stroke. The second aim was to determine the factors predicting 6MWT distance in patients with chronic stroke.
Detailed description
There may be large variations in the distance of 6MWT according to the stroke severity. Investigation of factors related to 6MWT may be helpful in determining and targeting appropriate strategies for gait rehabilitation. Accordingly, the first aim of this study was to investigate the reference values of 6-minute walk test (6MWT) distance in patients with chronic stroke. The second aim was to determine the factors predicting 6MWT distance in patients with chronic stroke.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke group | – | Other: Evaluation of 6-minute walking distance and related factors in patients with chronic strokepatients with chronic stroke |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with chronic stroke
Key inclusion criteria (4 listed)
- Having first ever stroke
- The time elapsed after the stroke is more than 6 months and less than 10 years
- 18-80 years old
- Those who could walk independently with no assistance or device and who could walk with an intermittent or continuous light touch to assist balance or coordination
Key exclusion criteria (3 listed)
- A history of severe musculoskeletal, cardiopulmonary, or psychiatric disease that can inhibit measurements
- Patients who had received a neurologic diagnosis other than stroke, such as Parkinson's disease or multiple sclerosis
- Patients with impaired level of consciousness and evidence of gross cognitive impairment (Scored below 10 points in the Mini-Mental State Examination
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 |
|---|---|---|
| Evaluation of 6-minute walking distance and related factors in patients with chronic strokeEvaluation of 6-minute walking distance and related factors in patients with chronic stroke. | Other | stroke group |
Primary outcome
6-minute walk test (6MWT)
Time frame: through study completion, an average of one month
6MWT will be used to evaluate the walking endurance. A 30-m indoor walkway will be used to conduct the test. The maximal distance covered at the end of the 6MWT will be recorded.
8 secondary outcomes
Functional ambulation scale (FAC)
Time frame: through study completion, an average of one month
Brunnstrom motor recovery staging
Time frame: through study completion, an average of one month
Modified Ashworth Scale (MAS)
Time frame: through study completion, an average of one month
Beck depression inventory (BDI)
Time frame: through study completion, an average of one month
Mini-mental state examination (MMSE)
Time frame: through study completion, an average of one month
Star cancellation test
Time frame: through study completion, an average of one month
Barthel Index
Time frame: through study completion, an average of one month
Berg Balance Scale (BBS)
Time frame: through study completion, an average of one month
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 5 Dec 2025.
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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, 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 4 inclusion and 3 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 5 Dec 2025. 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?
6-minute walk test (6MWT) (time frame: through study completion, an average of one month). 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 5 Dec 2025.