Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06434311
• Other study ID #: MarmaraU- AYDOGDU-SÜZÜK001
• Status: Recruiting
• Start date: March 15, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Marmara University
• Contact: Merve SÜZÜK Research Assistant
• Phone: 05317351127
• Email: mervesuzuk[@]halic.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Diagnostic Test:
• 3 meter Backward Test
evaluation

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Timed Up Go Test	The timed up and go test was developed in 1991 as a modified version of the get up and go test (Barry et al., 2014). The participant is asked to sit on a chair approximately 46 cm tall. Then, the participant gets up from the chair, walks 3 meters, walks the same distance back, and sits on the chair. The elapsed time is recorded (Barry et al., 2014; Ortega-Bastidas et al., 2023). A shorter time means a better score. The participant's failure to complete the test in less than 12 seconds indicates a high risk of falling (Nightingale et al., 2019).	At the baseline
Secondary	Frail Scale	It is a scale used to evaluate frailty in the elderly. The scale, consisting of 5 items, questions resistance, fatigue, ambulation, illness, and weight loss. Each question takes one of the values 0 or 1, with a total value of 0, indicating that the person is not frail. Values ranging from 1 to 2 are called pre-frail, and values above 2 are called fragile. In the disease questioning, the participant is asked how many of the 11 diseases he has. Having more than 5 diseases indicates a score of 1. The lowest score that can be obtained is zero, while the highest score is 5 (HYMABACCUS et al., 2023; Morley et al., 2012). Turkish validity and reliability study by Hymabaccus et al. Made by. Its reliability and validity have been reported as excellent, and the intraclass consistency coefficient varies between 0.68 and 0.82. (HYMABACCUS et al., 2023).	At the baseline
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	It has been translated into more than fifty languages. The commonly used knee injury and osteoarthritis outcome score consists of 5 subcategories. It is a 5-point Likert type scale consisting of 42 questions. A score ranging from 0 to 4 is given for each question. The total score for each subcategory is one hundred. While 0 indicates serious knee problems, 100 indicates no knee problems (Roos, 2023). Turkish validity and reliability were determined by Paker et al. It was conducted in 2007 and reported moderate validity and reliability (Paker et al., 2007). Internal consistency was calculated with Cronbach's alpha and was reported as 0.66 - 0.95 (Paker et al., 2007).	At the Baseline
Secondary	Modified Falls Efficacy Scale	It evaluates the individual's self-confidence regarding the fall. It is an expanded version of the falls effectiveness scale. It consists of 14 items. It evaluates a person's self-confidence during various daily activities. Each item is given a value ranging from 0-10. While 0 represents unsafe, the number 10 is considered completely safe. The highest score that can be obtained is 140 and the lowest score is 0 (Soh et al., 2021). Turkish validity and reliability study by Korkmaz et al. Made by. The intra-class consistency coefficient was reported as 0.978 (Korkmaz et al., 2019).	At the Baseline