NCT06540482

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

July 31, 2024

Last Update Submit

August 4, 2024

Conditions

Keywords

strokevalidity and reliability

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    The test will be administered first and third day.

Study Arms (1)

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

Interventions

Reliability testDIAGNOSTIC_TEST

The test was administered two days apart to evaluate the reliability of the retest test.

Stroke patients

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of additional orthopaedic, neurological or cardiovascular diseases that may affect balance and walking,
  • Uncorrectable visual and hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • EMEL TAŞVURAN HORATA, PhD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Associate Professor

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 6, 2024

Study Start

September 25, 2022

Primary Completion

July 25, 2024

Study Completion

July 25, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations