The Reliability and Validity of the Figure of 8 Walk Test and Double Task Figure of 8 Walk Test in Persons With Stroke

September 20, 2022 updated by: Güzin Kara, Pamukkale University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Kınıklı/Pamukkale
      • Denizli, Kınıklı/Pamukkale, Turkey, 20070
        • Pamukkale University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The presence of additional orthopedic, neurological or cardiovascular diseases that may affect balance and walking,
  • Uncorrected vision and hearing problems.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Evaluation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
six months
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).
six months
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.
six months
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).
six months
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).
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-60116787-020-217378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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