NCT06704217

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

November 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

November 21, 2024

Last Update Submit

January 12, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Six Spot Step Test-1

    The SSST wil be measured by the first investigator

    Day 1

  • Six Spot Step Test-2

    The SSST wil be measured by the second investigator

    Day 1

  • Six Spot Step Test-3

    The SSST wil be measured by the first investigator

    7-10 days after

  • Six Spot Step Test-4

    The SSST wil be measured by the second investigator

    7-10 days after

  • Timed Up and Go test

    A timed up and go test test will be measured for validity analysis.

    Day 1

  • Four Square Step Test

    A four square step test will be measured for validity analysis.

    Day 1

Study Arms (1)

Other

EXPERIMENTAL

Patients with total hip arthroplasty (THA)

Diagnostic Test: Six Spot Step TestDiagnostic Test: Oxford Hip ScoreDiagnostic Test: Berg Balance Scale

Interventions

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.

Other
Oxford Hip ScoreDIAGNOSTIC_TEST

The Oxford Hip Score will be used for functional level assessment.

Other
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.

Other

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Underwent primary unilateral Total Hip Arthroplasty (THA)
  • Surgery performed using the posterolateral approach
  • At least six months of postoperative follow-up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Officials

  • Elif AYGUN POLAT, PhD

    Ordu University

    STUDY DIRECTOR
  • Yusuf POLAT, Assoc. Prof.

    Ordu University

    PRINCIPAL INVESTIGATOR
  • Sevim ACAROZ, Assoc. Prof.

    Ordu University

    PRINCIPAL INVESTIGATOR
  • Yunus Emre OZBILEN, MD

    Ordu University

    PRINCIPAL INVESTIGATOR
  • Alper ÇIRAKLI, Prof.

    Ordu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 26, 2024

Study Start

November 30, 2024

Primary Completion

December 30, 2024

Study Completion

January 12, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations