Total Hip ReplacementSSSTNCT06704217
Reliability and Validity of the Six-Spot Step Test After Total Hip Arthroplasty
A study testing Six Spot Step Test, Oxford Hip Score and Berg Balance Scale in people with Total Hip Replacement and Reproducibility of Results, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to assess the SSST's validity, reliability, and ability to differentiate between high and low fall risk individuals in THA patients. Establishing the SSST as a valid and reliable tool will help manage rehabilitation and apply timely interventions for THA patients. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Total Hip Replacement, Reproducibility of Results, Rehabilitation
- What is being tested?
- Six Spot Step Test, Oxford Hip Score and Berg Balance Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 12 Jan 2025
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent primary unilateral Total Hip Arthroplasty (THA)
- Surgery performed using the posterolateral approach
- At least six months of postoperative follow-up
Who cannot join
- Patients who underwent bilateral or revision THA
- History of additional lower limb surgery
- Body mass index (BMI) greater than 40 kg/m²
- Neurological, orthopedic, or systemic disorders that could impair gait or balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Reliability and Validity of the Six-Spot Step Test in Patients Following Total Hip Arthroplasty
This study aims to assess the SSST's validity, reliability, and ability to differentiate between high and low fall risk individuals in THA patients. Establishing the SSST as a valid and reliable tool will help manage rehabilitation and apply timely interventions for THA patients.
Read the detailed description
Total hip arthroplasty (THA) is a common surgery for patients with advanced hip osteoarthritis, aiming to reduce pain and improve function. However, THA patients often experience difficulties in mobility tasks, such as walking, stair climbing, and standing up, even years after surgery. These functional impairments increase the risk of falls, highlighting the need for effective clinical tests to assess balance and mobility. Identifying factors contributing to balance dysfunction and implementing appropriate rehabilitation are crucial for improving quality of life.
The Six-Spot Step Test (SSST), developed by Nieuwenhuis et al., is a quick and easy test that evaluates balance and mobility in daily life activities. However, its validity and reliability in THA patients have not been studied. This research aims to assess the SSST's validity, reliability, and ability to differentiate between high and low fall risk individuals in THA patients. Establishing the SSST as a valid and reliable tool will help manage rehabilitation and apply timely interventions for THA patients.
- Being tested
- Six Spot Step Test, Oxford Hip Score, Berg Balance Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six Spot Step TestDiagnostic test
The Six-Spot Step Test (SSST), which evaluates balance and functional ambulation, will be performed in an area 5 meters long and 1 meter wide. Five wooden cylinders will be arranged in a zig-zag pattern within this space, with the last cylinder positioned at the centerline. The participant will be asked to strike the wooden cylinders with the medial or lateral side of the same foot and push them outward. The test will be repeated twice with the dominant foot and twice with the non-dominant foot. A trial will be conducted before the test to familiarize participants with the procedure. A two-minute rest period between the test and trials will be provided to minimize fatigue effects. The test's inter-rater reliability will be assessed by two physiotherapists with more than 5 years of clinical experience, who will administer the test twice at 5-minute intervals.
Oxford Hip ScoreDiagnostic test
The Oxford Hip Score will be used for functional level assessment.
Berg Balance ScaleDiagnostic test
The Berg Balance Scale (BBS) will be used to assess dynamic balance, which is reliable and commonly used within the orthopedic setting.
| Study group | Role | What they receive |
|---|---|---|
| Other | Experimental | Patients with total hip arthroplasty (THA) Receives: Diagnostic Test: Six Spot Step Test; Diagnostic Test: Oxford Hip Score; Diagnostic Test: Berg Balance Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Spot Step Test-1
The SSST wil be measured by the first investigator
Measured: Day 1
Six Spot Step Test-2
The SSST wil be measured by the second investigator
Measured: Day 1
Six Spot Step Test-3
The SSST wil be measured by the first investigator
Measured: 7-10 days after
Six Spot Step Test-4
The SSST wil be measured by the second investigator
Measured: 7-10 days after
Timed Up and Go test
A timed up and go test test will be measured for validity analysis.
Measured: Day 1
Four Square Step Test
A four square step test will be measured for validity analysis.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start30 Nov 2024
- Primary completion30 Dec 2024
- Study completion12 Jan 2025
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 ReplacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif AYGUN POLAT, Ordu University
- Investigators
- Elif AYGUN POLAT, PhD, Study director, Ordu UniversityYusuf POLAT, Assoc. Prof., Principal investigator, Ordu UniversitySevim ACAROZ, Assoc. Prof., Principal investigator, Ordu UniversityYunus Emre OZBILEN, MD, Principal investigator, Ordu UniversityAlper ÇIRAKLI, Prof., Study chair, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704217
- Sponsor's protocol ID
- ODU-SBFTR-AYGUNPOLAT-003
- Other IDs
- 2024/20
- Acronym
- SSST
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Aygun-Polat E, Polat Y, Ozbilen YE, Altun A, Acaroz S, Cirakli A. Reliability and validity of the Six-Spot Step Test in patients with total hip arthroplasty. Physiotherapy. 2026 Mar;130:101848. doi: 10.1016/j.physio.2025.101848. Epub 2025 Sep 15.
PubMed 41289866
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Reliability and Validity of the Six-Spot Step Test in Patients Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06704217
- Acronym / sponsor ID
- SSST / ODU-SBFTR-AYGUNPOLAT-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 26 Nov 2024 (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.
This study aims to assess the SSST's validity, reliability, and ability to differentiate between high and low fall risk individuals in THA patients. Establishing the SSST as a valid and reliable tool will help manage rehabilitation and apply timely interventions for THA patients.
Detailed description
Total hip arthroplasty (THA) is a common surgery for patients with advanced hip osteoarthritis, aiming to reduce pain and improve function. However, THA patients often experience difficulties in mobility tasks, such as walking, stair climbing, and standing up, even years after surgery. These functional impairments increase the risk of falls, highlighting the need for effective clinical tests to assess balance and mobility. Identifying factors contributing to balance dysfunction and implementing appropriate rehabilitation are crucial for improving quality of life.
The Six-Spot Step Test (SSST), developed by Nieuwenhuis et al., is a quick and easy test that evaluates balance and mobility in daily life activities. However, its validity and reliability in THA patients have not been studied. This research aims to assess the SSST's validity, reliability, and ability to differentiate between high and low fall risk individuals in THA patients. Establishing the SSST as a valid and reliable tool will help manage rehabilitation and apply timely interventions for THA patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other | Experimental | Diagnostic Test: Six Spot Step Test, Diagnostic Test: Oxford Hip Score, Diagnostic Test: Berg Balance ScalePatients with total hip arthroplasty (THA) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Underwent primary unilateral Total Hip Arthroplasty (THA)
- Surgery performed using the posterolateral approach
- At least six months of postoperative follow-up
Key exclusion criteria (4 listed)
- Patients who underwent bilateral or revision THA
- History of additional lower limb surgery
- Body mass index (BMI) greater than 40 kg/m²
- Neurological, orthopedic, or systemic disorders that could impair gait or balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six Spot Step TestThe Six-Spot Step Test (SSST), which evaluates balance and functional ambulation, will be performed in an area 5 meters long and 1 meter wide. Five wooden cylinders will be arranged in a zig-zag pattern within this space, with the last cylinder positioned at the centerline. The participant will be asked to strike the wooden cylinders with the medial or lateral side of the same foot and push them outward. The test will be repeated twice with the dominant foot and twice with the non-dominant foot. A trial will be conducted before the test to familiarize participants with the procedure. A two-minute rest period between the test and trials will be provided to minimize fatigue effects. The test's inter-rater reliability will be assessed by two physiotherapists with more than 5 years of clinical experience, who will administer the test twice at 5-minute intervals. | Diagnostic test | Other |
| Oxford Hip ScoreThe Oxford Hip Score will be used for functional level assessment. | Diagnostic test | Other |
| Berg Balance ScaleThe Berg Balance Scale (BBS) will be used to assess dynamic balance, which is reliable and commonly used within the orthopedic setting. | Diagnostic test | Other |
Primary outcome
Six Spot Step Test-1
Time frame: Day 1
The SSST wil be measured by the first investigator
Six Spot Step Test-2
Time frame: Day 1
The SSST wil be measured by the second investigator
Six Spot Step Test-3
Time frame: 7-10 days after
The SSST wil be measured by the first investigator
Six Spot Step Test-4
Time frame: 7-10 days after
The SSST wil be measured by the second investigator
Timed Up and Go test
Time frame: Day 1
A timed up and go test test will be measured for validity analysis.
Four Square Step Test
Time frame: Day 1
A four square step test will be measured for validity analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 41289866Aygun-Polat E, Polat Y, Ozbilen YE, Altun A, Acaroz S, Cirakli A. Reliability and validity of the Six-Spot Step Test in patients with total hip arthroplasty. Physiotherapy. 2026 Mar;130:101848. doi: 10.1016/j.physio.2025.101848. Epub 2025 Sep 15.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Not yet recruiting
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Total Hip Arthroplasty (THA)
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.
Elif AYGUN POLAT, PhD study director
Ordu University
Yusuf POLAT, Assoc. Prof. principal investigator
Ordu University
Sevim ACAROZ, Assoc. Prof. principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six Spot Step Test, Oxford Hip Score and Berg Balance Scale in people with Total Hip Replacement and Reproducibility of Results, run by Ordu 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Spot Step Test-1 (time frame: Day 1). The study lists 6 primary outcomes in all. 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 NCT06704217, 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 14 Jan 2025.