Total Hip ArthroplastyNCT05054192
Reliability and Validity of Modified Four Square Step Test
An observational study of Total Hip Arthroplasty, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Hip Arthroplasty
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Being between the ages of 18-85.
- Having undergone primary total hip arthroplasty at least ≥6 months ago.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Science University
Afyonkarahisar, 03030
EMEL TAŞVURAN HORATA, PhD, +905547759663, ethorata@gmail.com
EMEL TAŞVURAN HORATA, PhD
About this study
Official title: Evaluation of Test-retest Reliability, Concurrent Validity and Minimal Detectable Change of the Modified Four Square Step Test in Individuals With Primary Total Hip Arthroplasty.
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.
Read the 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.
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.
- Conditions
- Total Hip Arthroplasty
- Keywords
- Postural Balance, Total Hip Arthroplasty, Falling
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 minutes
Secondary outcomes (2)
Dynamic Balance
Dynamic balance will be evaluated with the timed and go test and the test completion time will be recorded in seconds.
Measured: 4 minutes
Dynamic Balance
Dynamic balance will be evaluated with the Berg Balance Test. The scores from the test will be recorded.
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054192
- Sponsor's protocol ID
- 2021/414
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39593608
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Test-retest Reliability, Concurrent Validity and Minimal Detectable Change of the Modified Four Square Step Test in Individuals With Primary Total Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT05054192
- Acronym / sponsor ID
- 2021/414
- Conditions
- Total Hip Arthroplasty
- Keywords
- Postural Balance, Total Hip Arthroplasty, Falling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Being between the ages of 18-85.
- Having undergone primary total hip arthroplasty at least ≥6 months ago.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic Balance
Time frame: 6 minutes
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.
2 secondary outcomes
Dynamic Balance
Time frame: 4 minutes
Dynamic Balance
Time frame: 25 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 39593608Horata 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMEL TAŞVURAN HORATA, PhD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EMEL TAŞVURAN HORATA, PhD (+905547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Balance (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.