- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704217
Reliability and Validity of the Six-Spot Step Test After Total Hip Arthroplasty (SSST)
Assessment of the Reliability and Validity of the Six-Spot Step Test in Patients Following Total Hip Arthroplasty
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ordu, Turkey
- Ordu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Underwent primary unilateral Total Hip Arthroplasty (THA)
- Surgery performed using the posterolateral approach
- At least six months of postoperative follow-up
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Other
Patients with total hip arthroplasty (THA)
|
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.
The Oxford Hip Score will be used for functional level assessment.
The Berg Balance Scale (BBS) will be used to assess dynamic balance, which is reliable and commonly used within the orthopedic setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six Spot Step Test-3
Time Frame: 7-10 days after
|
The SSST wil be measured by the first investigator
|
7-10 days after
|
|
Six Spot Step Test-4
Time Frame: 7-10 days after
|
The SSST wil be measured by the second investigator
|
7-10 days after
|
|
Six Spot Step Test-1
Time Frame: Day 1
|
The SSST wil be measured by the first investigator
|
Day 1
|
|
Six Spot Step Test-2
Time Frame: Day 1
|
The SSST wil be measured by the second investigator
|
Day 1
|
|
Timed Up and Go test
Time Frame: Day 1
|
A timed up and go test test will be measured for validity analysis.
|
Day 1
|
|
Four Square Step Test
Time Frame: Day 1
|
A four square step test will be measured for validity analysis.
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elif AYGUN POLAT, PhD, T.C. ORDU ÜNİVERSİTESİ
- Principal Investigator: Yusuf POLAT, Assoc. Prof., T.C. ORDU ÜNİVERSİTESİ
- Principal Investigator: Sevim ACAROZ, Assoc. Prof., T.C. ORDU ÜNİVERSİTESİ
- Principal Investigator: Yunus Emre OZBILEN, MD, T.C. ORDU ÜNİVERSİTESİ
- Study Chair: Alper ÇIRAKLI, Prof., T.C. ORDU ÜNİVERSİTESİ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ODU-SBFTR-AYGUNPOLAT-003
- 2024/20 (Other Identifier: Ordu University Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rehabilitation
-
Mississippi State UniversityUniversity of Mississippi Medical CenterNot yet recruitingPostoperative Rehabilitation | Hand Injury RehabilitationUnited States
-
Ankara Etlik City HospitalRecruitingStroke Rehabilitation | Stroke Rehabilitation and CaregiversTurkey (Türkiye)
-
Asan Medical CenterRecruitingPulmonary Rehabilitation | Cardiac RehabilitationKorea, Republic of
-
Westfälische Wilhelms-Universität MünsterNational Paralympic Committee Germany (NPCG)CompletedCardiac Rehabilitation | Feasibility Studies | Organization and Administration | Rehabilitation ExerciseGermany
-
Suleyman Demirel UniversityCompleted
-
Orton Orthopaedic HospitalCompleted
-
University Hospital, ToursCompletedPulmonary Rehabilitation | Respiratory RehabilitationFrance
-
Richard Watson, PTCompletedMedial Patellar Femoral Ligament Reconstruction Rehabilitation | Anterior Cruciate Ligament Reconstruction RehabilitationUnited States
-
Pakistan Institute of Medical SciencesNot yet recruiting
-
Changi General HospitalNot yet recruitingRehabilitation ExerciseSingapore
Clinical Trials on Six Spot Step Test
-
Faculdades Metropolitanas UnidasCompleted
-
Universidade Federal de PernambucoCompletedObstructive Sleep ApneaBrazil
-
Universidade Federal de Sao CarlosConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedChronic Obstructive Pulmonary DiseaseBrazil
-
Rennes University HospitalCompleted
-
M.D. Anderson Cancer CenterCompleted
-
St. Jude Children's Research HospitalOxford ImmunotecTerminated
-
University Health Network, TorontoOxford ImmunotecCompleted
-
University Hospital, BrestMinistry of Health, FranceCompleted
-
University Hospital of CologneCompleted
-
Cliniques universitaires Saint-Luc- Université...Completed