Reliability and Validity of the Six-Spot Step Test After Total Hip Arthroplasty (SSST)

January 12, 2025 updated by: Elif AYGUN POLAT, T.C. ORDU ÜNİVERSİTESİ

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.

Study Overview

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

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ordu, Turkey
        • Ordu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

January 12, 2025

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 12, 2025

Last Verified

January 1, 2025

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)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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