NCT06434311

Brief Summary

Osteoarthritis of the knee is a common joint disease that causes loss of balance and proprioception. Changes in the knee joint such as mechanoreceptor loss, muscle strength imbalance, muscle weakness, capsular hypertrophy, subchondral edema, and increased loss of balance and proprioception lead to an increased risk of falls. In the literature, knee osteoarthritis is repeatedly mentioned as an independent risk factor for falls, and knee osteoarthritis is associated with recurrent falls. There are many performance-based clinical measurement tests that assess fall risk in knee osteoarthritis. Some of these tests include the timed up and walk test, the five-step sit-to-stand test, and the one-leg stand test. These tests cannot evaluate backward walking. Backward walking requires more neuromuscular control and proprioception than forward walking. The 3-meter backward walk test is a performance-based test that assesses backward walking, balance, proprioception, and neuromuscular control. The participant is asked to walk 3 meters backwards on a flat surface at the highest speed at which they feel comfortable without running. It is administered by recording the time elapsed. The validity and reliability of the 3-meter walk back test have been previously investigated in many patient populations and healthy individuals. However, to our knowledge, there is no research on the reliability and validity of a 3-meter walk back test in knee osteoarthritis. Clinical measurement tests should be valid and reliable in the patient population to which they are applied. The aim of this study was to examine the test-retest reliability and concurrent validity of the 3-meter backward walk test in participants with knee osteoarthritis. In addition, we aim to compare the 3-meter backward walk test scores of individuals with and without knee osteoarthritis and to examine the change in 3-meter backward walk test scores with the change in disease severity. The data collection tools to be used in the study are the 3-meter walk back test, the timed get up and walk test, the Knee Injuries and Osteoarthritis Outcome Score, the Frail Scale, the Modified Falls Efficacy Scale, and fall history. All of these measures will be taken at the initial assessment, and the 3-meter walk back test will be repeated after 3-7 days. We hope that our study will help physiotherapists working in this field in the clinical decision-making process by providing a valid and reliable performance test for the assessment of fall risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 7, 2025

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

May 23, 2024

Last Update Submit

May 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 3 meter Backward Test

    It is a performance-based test developed by Carter et al. A 3 meter long strip is drawn on the ground. It assesses fall risk, balance, neuromuscular control. Participants are expected to walk backwards for 3 meters as fast as possible. The time until the participant completes the walk is recorded. A lower score indicates higher performance (Carter et al., 2019).

    At the baseline

  • 3 meter Backward Test

    It is a performance-based test developed by Carter et al. A 3 meter long strip is drawn on the ground. It assesses fall risk, balance, neuromuscular control. Participants are expected to walk backwards for 3 meters as fast as possible. The time until the participant completes the walk is recorded. A lower score indicates higher performance (Carter et al., 2019).

    One week later

Secondary Outcomes (4)

  • Timed Up Go Test

    At the baseline

  • Frail Scale

    At the baseline

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    At the Baseline

  • Modified Falls Efficacy Scale

    At the Baseline

Study Arms (1)

Knee Osteoarthritis

Patients who who have knee osteoarthritis categorized as 1 - 4 according to Kellgren - Lawrence

Diagnostic Test: 3 meter Backward Test

Interventions

3 meter Backward TestDIAGNOSTIC_TEST

evaluation

Knee Osteoarthritis

Eligibility Criteria

Age39 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who have diagnosed as knee osteoarthritis

You may qualify if:

  • To have been diagnosed with osteoarthritis by a specialist physician according to the clinical and radiological criteria of the American College of Rheumatology.
  • Be between 40 and 75 years of age.
  • Being in grade 1-4 according to Kellgren-Lawrence staging.
  • To participate in the study voluntarily

You may not qualify if:

  • Having undergone surgery involving the lower extremity
  • Having prosthesis or orthosis in the lower extremity
  • Other neurological and cardiopulmonary diseases that may affect walking and balance Having undergone surgery or invasive treatment in the last 6 months
  • Body mass index above 45
  • Having severe heart disease that prevents exercise
  • Having pain originating from L3 - S1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 30, 2024

Study Start

March 15, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

May 7, 2025

Record last verified: 2024-03

Locations