Reliability and Validity of The Figure of 8 Walk Test With and Without Dual-Task

August 4, 2024 updated by: Emel Taşvuran Horata, Afyonkarahisar Health Sciences University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

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 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 (Actual)

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.
32

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

  • Turkey
      • Afyonkarahisar, Turkey, 03030
        • Afyonkarahisar Health Science 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Presence of additional orthopaedic, neurological or cardiovascular diseases that may affect balance and walking,
  • Uncorrectable visual 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
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.
Diagnostic test: Reliability test
The test was administered two days apart to evaluate the reliability of the retest test.

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
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.
The test will be administered first and third day.
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.
The test will be administered first and third day.

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.
Afyonkarahisar Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: EMEL TAŞVURAN HORATA, PhD, Afyonkarahisar Health Sciences University

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)

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.
September 25, 2022

Primary Completion (Actual)

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.
July 25, 2024

Study Completion (Actual)

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.
July 25, 2024

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).
July 31, 2024

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.
August 4, 2024

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.
August 6, 2024

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.
August 6, 2024

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.
August 4, 2024

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.
August 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 07.05.2022-09

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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