- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06646003
Reference Values and Determinants of 6-minute Walk Test
December 4, 2025 updated by: Merve Örücü Atar, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
341
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey (Türkiye)
- Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
patients with chronic stroke
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
stroke group
patients with chronic stroke
|
Evaluation of 6-minute walking distance and related factors in patients with chronic stroke.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional ambulation scale (FAC)
Time Frame: through study completion, an average of one month
|
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).
|
through study completion, an average of one month
|
|
Brunnstrom motor recovery staging
Time Frame: through study completion, an average of one month
|
Upper extremity, hand and lower extremity motor recovery will be assessed using the Brunnstrom 6 sequential stages of motor recovery.
|
through study completion, an average of one month
|
|
Beck depression inventory (BDI)
Time Frame: through study completion, an average of one month
|
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.
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through study completion, an average of one month
|
|
Mini-mental state examination (MMSE)
Time Frame: through study completion, an average of one month
|
The mini-mental state examination will be used to describe mental and cognitive functions.
|
through study completion, an average of one month
|
|
Star cancellation test
Time Frame: through study completion, an average of one month
|
Star cancellation test will be used to describe neglect phenomenon.
|
through study completion, an average of one month
|
|
Barthel Index
Time Frame: through study completion, an average of one month
|
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.
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through study completion, an average of one month
|
|
Berg Balance Scale (BBS)
Time Frame: through study completion, an average of one month
|
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.
|
through study completion, an average of one month
|
|
Modified Ashworth Scale (MAS)
Time Frame: through study completion, an average of one month
|
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.
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through study completion, an average of one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2024
Primary Completion (Actual)
November 25, 2025
Study Completion (Actual)
November 25, 2025
Study Registration Dates
First Submitted
October 15, 2024
First Submitted That Met QC Criteria
October 15, 2024
First Posted (Actual)
October 17, 2024
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-24-599
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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