StrokeNCT05552885
The Reliability and Validity of the Figure of 8 Walk Test and Double Task Figure of 8 Walk Test in Persons With Stroke
An observational study of Stroke, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The validity of the dual-task F8W test in predicting falls in older adults has been confirmed. As far as we know, there are no studies evaluating the validity and reliability of the dual-task F8W test in stroke patients. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Evaluation
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 30 Aug 2023
- How long will I take part?
- 1 Day
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Since the incidence of stroke nearly doubles every ten years after the age of 55 (Feigin, Lawes, Bennett, \& Anderson, 2003), individuals with stroke aged 50 and over will be included in the study.
Who may be able to join
- Being 50 years of age and older,
- Having only one unilateral stroke at least 6 months prior to the study,
- Being medically stable,
- Being able to walk at least 10 meters with a cane or independently,
- Getting 24 points or more from the Standardized Mini-Mental Test',
- Being to be able to perform the cognitive task (subtraction) to be given during the evaluations.
Who cannot join
- The presence of additional orthopedic, neurological or cardiovascular diseases that may affect balance and walking,
- Uncorrected vision and hearing problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Kınıklı/Pamukkale, 20070
About this study
The validity of the dual-task F8W test in predicting falls in older adults has been confirmed. As far as we know, there are no studies evaluating the validity and reliability of the dual-task F8W test in stroke patients. Therefore, the aim of the study is to evaluate the validity and reliability of the F8W and dual-task F8W test in stroke patients.
Read the detailed description
Recently, the validity and reliability of assessment tools in which two tasks are performed simultaneously have been investigated. Although the utility of dual-task assessments in assessing falls in neurological diseases is uncertain, the reliability of dual-task assessments involving walking has shown quite good results. Stroke survivors have decreases in one or both (locomotor and cognitive) performances while walking and simultaneously performing a cognitive task. The tasks selected in dual-task evaluations may affect dual-task interactions, therefore, tasks that are compatible with daily living activities should be used in dual-task evaluations. A previous study confirmed the validity of the dual-task F8W test in predicting falls in older adults. Because of this reaason, stroke patients aged 50 and over will be included in the study.
- Conditions
- Stroke
- Being tested
- Evaluation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
The Standardized Mini Mental Test, The American National Institutes of Health Stroke Scale, the Figure of 8 Walk Test, the double-task octagonal gait test, the timed up-and-go test, the 10-meter walk test, and the modified four-square step test will be applied to the stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | General cognitive level will be evaluated with the Standardized Mini Mental Test to determine the eligibility of the participants for the study. The American National Institutes of Health Stroke Scale will be applied to determine the stroke severity and functional status of the participants. The reliability and validity of the eight-shape gait test and the double-task octagonal gait test will be examined. The reliability of the tests will be evaluated by calculating the test-retest method, standard error measurement and minimum detectable change values. The initial test and retest will be evaluated two days apart. The concurrent validity of the tests will be evaluated by the correlation between the timed get-and-go test, the 10-meter walk test, and the modified four-square step test. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental Test
It is a practical, short and standardized test that evaluates cognition in general. It consists of five subsections and 11 items: orientation, recording memory, attention and calculation, recall and language. A total of 30 points can be obtained from the test. Scores below the 23/24 threshold for the Turkish population indicate dementia (Güngen, Ertan, Eker, Yaşar, \& Engin, 2002).
Measured: six months
National Institutes of Health Stroke Scale Score-NIHSS
The scale used to determine the severity of stroke consists of a total of 11 items. The highest score of the scale is 36. On the scale, >17 points are severe, 8-16 points are moderate, and <8 points indicate mild stroke (Brott et al., 1989).
Measured: six months
Figure of 8 Walk Test (F8WT)
Participants will be instructed to stand in the middle of two cones 1.52 m apart and walk around the cones at their normal walking pace, in the direction of their choice, in a figure eight, and stop when they reach the starting point. The time to complete the test will be recorded. The original F8W test also takes into account the number of steps and gait smoothness required to complete the task (Hess et al., 2010). Only the time to complete F8W will be used in this study, as time is more objective than smoothness and number of steps in evaluating changes in walking performance.
Measured: six months
Timed Up and Go Test (TUG)
It is a valid and reliable tool that evaluates walking performance on flat roads in stroke individuals. The time it takes for an individual to complete 10 meters at normal walking speed at a distance of 14 m (the first and last 2 m distances are not considered) is recorded (Cheng, Nelson, Brooks, \& Salbach, 2020).
Measured: six months
Modified Four Square Step Test
It is a valid and reliable tool that evaluates the ability to take steps, change direction and turn in stroke individuals. Roos et al. It has been modified to reduce the risk of falling during testing. The test is applied by recording the time elapsed during the individual's stepping forward, backward and sideways in the areas marked from 1 to 4, which are glued to the ground in a square shape (Roos, Reisman, Hicks, \& Rudolph, 2016).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start10 Oct 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Kara, Pamukkale University
- Investigators
- Güzin Kara, PhD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552885
- Sponsor's protocol ID
- E-60116787-020-217378
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hess RJ, Brach JS, Piva SR, VanSwearingen JM. Walking skill can be assessed in older adults: validity of the Figure-of-8 Walk Test. Phys Ther. 2010 Jan;90(1):89-99. doi: 10.2522/ptj.20080121. Epub 2009 Dec 3.
PubMed 19959654Kim, Y.-H., & Lim, J.-H. The reliability and validity of figure-of-8 walk test in patients with stroke. Journal of the Korean Academy of Clinical Electrophysiology. 2012: 10(1); 29-37.
Lowry KA, Brach JS, Nebes RD, Studenski SA, VanSwearingen JM. Contributions of cognitive function to straight- and curved-path walking in older adults. Arch Phys Med Rehabil. 2012 May;93(5):802-7. doi: 10.1016/j.apmr.2011.12.007.
PubMed 22541307Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. doi: 10.1016/j.apmr.2005.01.011.
PubMed 16084820Nualyong T, Siriphorn A. Accuracy of the figure of 8 walk test with and without dual-task to predict falls in older adults. J Bodyw Mov Ther. 2022 Apr;30:69-75. doi: 10.1016/j.jbmt.2022.02.001. Epub 2022 Feb 7.
PubMed 35500981Roos MA, Reisman DS, Hicks G, Rose W, Rudolph KS. Development of the Modified Four Square Step Test and its reliability and validity in people with stroke. J Rehabil Res Dev. 2016;53(3):403-12. doi: 10.1682/JRRD.2014.04.0112.
PubMed 27271003Son H, Park C. Effect of turning direction on Timed Up and Go test results in stroke patients. Eur J Phys Rehabil Med. 2019 Feb;55(1):35-39. doi: 10.23736/S1973-9087.18.05202-4. Epub 2018 Jul 6.
PubMed 29984566Wong SS, Yam MS, Ng SS. The Figure-of-Eight Walk test: reliability and associations with stroke-specific impairments. Disabil Rehabil. 2013;35(22):1896-902. doi: 10.3109/09638288.2013.766274. Epub 2013 Apr 19.
PubMed 23600714
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Figure of 8 Walk Test and Double Task Figure of 8 Walk Test in Persons With Stroke
- ClinicalTrials.gov ID
- NCT05552885
- Acronym / sponsor ID
- E-60116787-020-217378
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 23 Sep 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 validity of the dual-task F8W test in predicting falls in older adults has been confirmed. As far as we know, there are no studies evaluating the validity and reliability of the dual-task F8W test in stroke patients. Therefore, the aim of the study is to evaluate the validity and reliability of the F8W and dual-task F8W test in stroke patients.
Detailed description
Recently, the validity and reliability of assessment tools in which two tasks are performed simultaneously have been investigated. Although the utility of dual-task assessments in assessing falls in neurological diseases is uncertain, the reliability of dual-task assessments involving walking has shown quite good results. Stroke survivors have decreases in one or both (locomotor and cognitive) performances while walking and simultaneously performing a cognitive task. The tasks selected in dual-task evaluations may affect dual-task interactions, therefore, tasks that are compatible with daily living activities should be used in dual-task evaluations. A previous study confirmed the validity of the dual-task F8W test in predicting falls in older adults. Because of this reaason, stroke patients aged 50 and over will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: EvaluationGeneral cognitive level will be evaluated with the Standardized Mini Mental Test to determine the eligibility of the participants for the study. The American National Institutes of Health Stroke Scale will be applied to determine the stroke severity and functional status of the participants. The reliability and validity of the eight-shape gait test and the double-task octagonal gait test will be examined. The reliability of the tests will be evaluated by calculating the test-retest method, standard error measurement and minimum detectable change values. The initial test and retest will be evaluated two days apart. The concurrent validity of the tests will be evaluated by the correlation between the timed get-and-go test, the 10-meter walk test, and the modified four-square step test. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Since the incidence of stroke nearly doubles every ten years after the age of 55 (Feigin, Lawes, Bennett, \& Anderson, 2003), individuals with stroke aged 50 and over will be included in the study.
Key inclusion criteria (6 listed)
- Being 50 years of age and older,
- Having only one unilateral stroke at least 6 months prior to the study,
- Being medically stable,
- Being able to walk at least 10 meters with a cane or independently,
- Getting 24 points or more from the Standardized Mini-Mental Test',
Key exclusion criteria (2 listed)
- The presence of additional orthopedic, neurological or cardiovascular diseases that may affect balance and walking,
- Uncorrected vision 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 |
|---|---|---|
| EvaluationThe Standardized Mini Mental Test, The American National Institutes of Health Stroke Scale, the Figure of 8 Walk Test, the double-task octagonal gait test, the timed up-and-go test, the 10-meter walk test, and the modified four-square step test will be applied to the stroke patients. | Other | Stroke patients |
Primary outcome
Standardized Mini Mental Test
Time frame: six months
It is a practical, short and standardized test that evaluates cognition in general. It consists of five subsections and 11 items: orientation, recording memory, attention and calculation, recall and language. A total of 30 points can be obtained from the test. Scores below the 23/24 threshold for the Turkish population indicate dementia (Güngen, Ertan, Eker, Yaşar, \& Engin, 2002).
National Institutes of Health Stroke Scale Score-NIHSS
Time frame: six months
The scale used to determine the severity of stroke consists of a total of 11 items. The highest score of the scale is 36. On the scale, >17 points are severe, 8-16 points are moderate, and <8 points indicate mild stroke (Brott et al., 1989).
Figure of 8 Walk Test (F8WT)
Time frame: six months
Participants will be instructed to stand in the middle of two cones 1.52 m apart and walk around the cones at their normal walking pace, in the direction of their choice, in a figure eight, and stop when they reach the starting point. The time to complete the test will be recorded. The original F8W test also takes into account the number of steps and gait smoothness required to complete the task (Hess et al., 2010). Only the time to complete F8W will be used in this study, as time is more objective than smoothness and number of steps in evaluating changes in walking performance.
Timed Up and Go Test (TUG)
Time frame: six months
It is a valid and reliable tool that evaluates walking performance on flat roads in stroke individuals. The time it takes for an individual to complete 10 meters at normal walking speed at a distance of 14 m (the first and last 2 m distances are not considered) is recorded (Cheng, Nelson, Brooks, \& Salbach, 2020).
Modified Four Square Step Test
Time frame: six months
It is a valid and reliable tool that evaluates the ability to take steps, change direction and turn in stroke individuals. Roos et al. It has been modified to reduce the risk of falling during testing. The test is applied by recording the time elapsed during the individual's stepping forward, backward and sideways in the areas marked from 1 to 4, which are glued to the ground in a square shape (Roos, Reisman, Hicks, \& Rudolph, 2016).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Results publication: PubMed 19959654Hess RJ, Brach JS, Piva SR, VanSwearingen JM. Walking skill can be assessed in older adults: validity of the Figure-of-8 Walk Test. Phys Ther. 2010 Jan;90(1):89-99. doi: 10.2522/ptj.20080121. Epub 2009 Dec 3.
- Results publicationKim, Y.-H., & Lim, J.-H. The reliability and validity of figure-of-8 walk test in patients with stroke. Journal of the Korean Academy of Clinical Electrophysiology. 2012: 10(1); 29-37.
- Results publication: PubMed 22541307Lowry KA, Brach JS, Nebes RD, Studenski SA, VanSwearingen JM. Contributions of cognitive function to straight- and curved-path walking in older adults. Arch Phys Med Rehabil. 2012 May;93(5):802-7. doi: 10.1016/j.apmr.2011.12.007.
- Results publication: PubMed 16084820Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. doi: 10.1016/j.apmr.2005.01.011.
- Results publication: PubMed 35500981Nualyong T, Siriphorn A. Accuracy of the figure of 8 walk test with and without dual-task to predict falls in older adults. J Bodyw Mov Ther. 2022 Apr;30:69-75. doi: 10.1016/j.jbmt.2022.02.001. Epub 2022 Feb 7.
- Results publication: PubMed 27271003Roos MA, Reisman DS, Hicks G, Rose W, Rudolph KS. Development of the Modified Four Square Step Test and its reliability and validity in people with stroke. J Rehabil Res Dev. 2016;53(3):403-12. doi: 10.1682/JRRD.2014.04.0112.
- Results publication: PubMed 29984566Son H, Park C. Effect of turning direction on Timed Up and Go test results in stroke patients. Eur J Phys Rehabil Med. 2019 Feb;55(1):35-39. doi: 10.23736/S1973-9087.18.05202-4. Epub 2018 Jul 6.
- Results publication: PubMed 23600714Wong SS, Yam MS, Ng SS. The Figure-of-Eight Walk test: reliability and associations with stroke-specific impairments. Disabil Rehabil. 2013;35(22):1896-902. doi: 10.3109/09638288.2013.766274. Epub 2013 Apr 19.
- Individual participant dataSharing planned: No
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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.
Güzin Kara, PhD principal investigator
Pamukkale 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 Pamukkale 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Güzin Kara, PhD (05393743451, guzin1196@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Mini Mental Test (time frame: six months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05552885, which also lists 8 linked publications.
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 23 Sep 2022.