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

Not yet recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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 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

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
Intervention / Treatment
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

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

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)

October 10, 2022

Primary Completion (ANTICIPATED)

February 28, 2023

Study Completion (ANTICIPATED)

August 30, 2023

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (ACTUAL)

September 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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