Reliability and Validity of Modified Four Square Step Test | NCT05054192

Studies
Reliability and Validity of Modified Four Square Step Test

NCT05054192

Sponsor

Afyonkarahisar Health Sciences University

Status

Unknown status

Last Update Posted

Sep 23, 2021Actual

Enrollment

28Estimated

Phase

Not provided

Conditions

Total Hip Arthroplasty

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Sep 1, 2023Estimated

First Submitted Date

Sep 10, 2021

First Submission Date that Met QC Criteria

Sep 21, 2021

First Posted Date

Sep 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2021

Last Update Posted Date

Sep 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emel Taşvuran Horata, PhD; Assistant Professor, Afyonkarahisar Health Sciences UniversityPrincipal Investigator

Lead Sponsor

Afyonkarahisar Health Sciences UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Functional improvements are reached in patients with primary total hip arthroplasty compared to the pre-operative term however some problems as continued range of motion limitations, loss of joint proprioception sensation, and resulting balance and gait disorders may result in failure of the Four Square Step Test. Therefore, the need for the apply of the Modified Four Square Step Test in individuals with primary THA is necessary. The aim of this study is to evaluate the test-retest reliability, concurrent validity and minimal detectable change of the Modified Four Square Step Test in individuals with primary total hip arthroplasty.

Detailed Description

Roos et al. improved the Modified Four-Square Step Test to complete the test by stroke patients and not to fall due to practices of the test while performing the test. The Modified Four Square Step Test variates from the The Four Square Step Test is that the person is not asked to look ahead during the test, and instead of using a cane, tapes are used to prevent people from losing their balance by tripping over the obstacle. Thus, although the height of the obstacle is reduced, the boundaries of the obstacle are preserved.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dynamic Balance	Dynamic balance is the ability of an object to balance while in motion or switching between positions. Dynamic balance will be evaluated with the modified four square step test. The duration as second will be recorded.	6 minutes

Secondary Outcomes

Measure	Description	Time Frame
Dynamic Balance	Dynamic balance will be evaluated with the timed and go test and the test completion time will be recorded in seconds.	4 minutes
Dynamic Balance	Dynamic balance will be evaluated with the Berg Balance Test. The scores from the test will be recorded.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being between the ages of 18-85.
Having undergone primary total hip arthroplasty at least ≥6 months ago.

Exclusion Criteria:

Having severe cardiovascular or lung disease
Having severe dementia or communication difficulties
Having a musculoskeletal or neurological problem that may affect participation in balance tests
Having an uncorrectable visual impairment
Having a body mass index of more than 40 kg/m2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

In this study, the participants will consist of individuals who have previously undergone primary total hip arthroplasty in Afyonkarahisar Health Sciences University Health Practice and Research Center Orthopedics and Traumatology Polyclinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
EMEL TAŞVURAN HORATA, PhD	Contact	+905547759663		ethorata@gmail.com

Overall Officials

Name	Affiliation	Role
EMEL TAŞVURAN HORATA, PhD	Afyonkarahisar Health Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Afyonkarahisar Health Science University	Recruiting	Afyonkarahisar		03030	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39593608	Derived	Horata ET, Eken F, Yesil M, Ozcan O. Validity and reliability of the modified four square step test in total HIP arthroplasty. J Bodyw Mov Ther. 2024 Oct;40:345-349. doi: 10.1016/j.jbmt.2024.04.028. Epub 2024 Apr 16.