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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05054192
Other study ID # 2021/414
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2023

Study information

Verified date September 2021
Source Afyonkarahisar Health Sciences University
Contact EMEL TASVURAN HORATA, PhD
Phone +905547759663
Email ethorata@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date September 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Afyonkarahisar Health Science University Afyonkarahisar

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Dynamic Balance Dynamic balance will be evaluated with the Berg Balance Test. The scores from the test will be recorded. 25 minutes
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