StrokeNCT06540482
Reliability and Validity of The Figure of 8 Walk Test With and Without Dual-Task
An observational study of Stroke, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Reliability test
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2022to 25 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants consisted of stroke patients aged 50 years and older who were followed up and treated by Pamukkale University Adult Neurological Rehabilitation-Outpatient Unit
Who may be able to join
- 50 years of age or older,
- Having had only one unilateral stroke at least 6 months before the study,
- Being medically stable,
- Being able to walk at least 10 metres with a cane or independently,
- Getting at least 24 points from the Standardised Mini Mental Test,
- Being able to perform the cognitive task (subtraction) given during the assessments.
Who cannot join
- Presence of additional orthopaedic, neurological or cardiovascular diseases that may affect balance and walking,
- Uncorrectable visual and hearing problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar, 03030
About this study
Official title: Reliability and Validity of the Figure of 8 Walk Test With and Without Dual-Task in Individuals With Stroke
For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Assessing a person with stroke walking on a straight path may not be indicative of real-life gait-related performance. The Figure of 8 Walk Test (F8WT) includes a straight and curved gait that may represent the daily gait. To the best of our knowledge, there are no studies evaluating the reliability and validity of the dual-task F8W test in individuals with stroke. Therefore, the aim of this study was to evaluate the validity and reliability of the F8W and dual-task F8W test in individuals with stroke.
Read the detailed description
For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Assessing a person with stroke walking on a straight path may not be indicative of real-life gait-related performance. The Figure of 8 Walk Test (F8WT) includes a straight and curved gait that may represent the daily gait. To the best of our knowledge, there are no studies evaluating the reliability and validity of the dual-task F8W test in individuals with stroke. Therefore, the aim of this study was to evaluate the validity and reliability of the F8W and dual-task F8W test in individuals with stroke.
This prospectively designed study evaluated the demographic and clinical characteristics of the participants. The main outcome measures included the F8WT, dual-task F8WT, Standardised Mini Mental Test, The National Institutes of Health Stroke Scale, Timed-Up and Go Test, 10-metre walk test, Modified Four Square Step Test and Six-Spot Step Test.
- Conditions
- Stroke
- Being tested
- Reliability test
- Keywords
- stroke, validity and reliability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reliability testDiagnostic test
The test was administered two days apart to evaluate the reliability of the retest test.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | The participants consisted of stroke patients aged 50 years and older who were followed up and treated by Pamukkale University Adult Neurological Rehabilitation - Outpatient Unit. Receives: Diagnostic Test: Reliability test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Figure of 8 Walk Test (F8WT)
The test starts from the center of two cones at a certain distance. Participants are asked to walk around the cones in 8 shapes at their normal walking speed. The test ends when the participant reaches the starting point again. The duration of the test is recorded in seconds.
Measured: The test will be administered first and third day.
Dual-task The Figure of 8 Walk Test (F8WT)
The test starts from the center of two cones at a certain distance. Participants were asked to walk around the cones in 8 shapes at their normal walking speed when they conducted the cognitive or motor task. The test ends when the participant reaches the starting point again. The duration of the test is recorded in seconds.
Measured: The test will be administered first and third day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start25 Sep 2022
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
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
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540482
- Sponsor's protocol ID
- 07.05.2022-09
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Figure of 8 Walk Test With and Without Dual-Task in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT06540482
- Acronym / sponsor ID
- 07.05.2022-09
- Conditions
- Stroke
- Keywords
- stroke, validity and reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Sep 2022 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 6 Aug 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.
For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Assessing a person with stroke walking on a straight path may not be indicative of real-life gait-related performance. The Figure of 8 Walk Test (F8WT) includes a straight and curved gait that may represent the daily gait. To the best of our knowledge, there are no studies evaluating the reliability and validity of the dual-task F8W test in individuals with stroke. Therefore, the aim of this study was to evaluate the validity and reliability of the F8W and dual-task F8W test in individuals with stroke.
Detailed description
For people with stroke, walking on a curved path is more difficult than walking on a straight path and can lead to falls. Most of the outcome scales assessing the gait of people with stroke involve walking in a straight line or with one turn. Assessing a person with stroke walking on a straight path may not be indicative of real-life gait-related performance. The Figure of 8 Walk Test (F8WT) includes a straight and curved gait that may represent the daily gait. To the best of our knowledge, there are no studies evaluating the reliability and validity of the dual-task F8W test in individuals with stroke. Therefore, the aim of this study was to evaluate the validity and reliability of the F8W and dual-task F8W test in individuals with stroke.
This prospectively designed study evaluated the demographic and clinical characteristics of the participants. The main outcome measures included the F8WT, dual-task F8WT, Standardised Mini Mental Test, The National Institutes of Health Stroke Scale, Timed-Up and Go Test, 10-metre walk test, Modified Four Square Step Test and Six-Spot Step Test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Diagnostic Test: Reliability testThe participants consisted of stroke patients aged 50 years and older who were followed up and treated by Pamukkale University Adult Neurological Rehabilitation - Outpatient Unit. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants consisted of stroke patients aged 50 years and older who were followed up and treated by Pamukkale University Adult Neurological Rehabilitation-Outpatient Unit
Key inclusion criteria (6 listed)
- 50 years of age or older,
- Having had only one unilateral stroke at least 6 months before the study,
- Being medically stable,
- Being able to walk at least 10 metres with a cane or independently,
- Getting at least 24 points from the Standardised Mini Mental Test,
Key exclusion criteria (2 listed)
- Presence of additional orthopaedic, neurological or cardiovascular diseases that may affect balance and walking,
- Uncorrectable visual and hearing problems
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 |
|---|---|---|
| Reliability testThe test was administered two days apart to evaluate the reliability of the retest test. | Diagnostic test | Stroke patients |
Primary outcome
The Figure of 8 Walk Test (F8WT)
Time frame: The test will be administered first and third day.
The test starts from the center of two cones at a certain distance. Participants are asked to walk around the cones in 8 shapes at their normal walking speed. The test ends when the participant reaches the starting point again. The duration of the test is recorded in seconds.
Dual-task The Figure of 8 Walk Test (F8WT)
Time frame: The test will be administered first and third day.
The test starts from the center of two cones at a certain distance. Participants were asked to walk around the cones in 8 shapes at their normal walking speed when they conducted the cognitive or motor task. The test ends when the participant reaches the starting point again. The duration of the test is recorded in seconds.
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 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
EMEL TAŞVURAN HORATA, PhD principal investigator
Afyonkarahisar Health Sciences University
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 Afyonkarahisar Health Sciences University 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 6 inclusion and 2 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 6 Aug 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?
The Figure of 8 Walk Test (F8WT) (time frame: The test will be administered first and third day.). The study lists 2 primary outcomes in all. 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 6 Aug 2024.