NCT05054192

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

September 10, 2021

Last Update Submit

September 21, 2021

Conditions

Keywords

Postural BalanceTotal Hip ArthroplastyFalling

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Dynamic Balance

    4 minutes

  • Dynamic Balance

    25 minutes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

Study Officials

  • EMEL TAŞVURAN HORATA, PhD

    Afyonkarahisar Health Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EMEL TAŞVURAN HORATA, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 23, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations