Knee OsteoarthritisNCT06434311
Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Marmara University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 39 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- 3 meter Backward Test
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People who have diagnosed as knee osteoarthritis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- 3 meter Backward Test
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 meter Backward TestDiagnostic test
evaluation
| Study group | Role | What they receive |
|---|---|---|
| Knee Osteoarthritis | Patients who who have knee osteoarthritis categorized as 1 - 4 according to Kellgren - Lawrence Receives: Diagnostic Test: 3 meter Backward Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: One week later
Secondary outcomes (4)
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).
Measured: At the baseline
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).
Measured: At the baseline
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).
Measured: At the Baseline
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).
Measured: At the Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start15 Mar 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434311
- Sponsor's protocol ID
- MarmaraU- AYDOĞDU-SÜZÜK001
- Status last verified
- Mar 2024
- First submitted
- 23 May 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06434311
- Acronym / sponsor ID
- MarmaraU- AYDOĞDU-SÜZÜK001
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis | – | Diagnostic Test: 3 meter Backward TestPatients who who have knee osteoarthritis categorized as 1 - 4 according to Kellgren - Lawrence |
Who may qualify
- Ages
- 39 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have diagnosed as knee osteoarthritis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 meter Backward Testevaluation | Diagnostic test | Knee Osteoarthritis |
Primary outcome
3 meter Backward Test
Time frame: At the baseline
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).
3 meter Backward Test
Time frame: One week later
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).
4 secondary outcomes
Timed Up Go Test
Time frame: At the baseline
Frail Scale
Time frame: At the baseline
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At the Baseline
Modified Falls Efficacy Scale
Time frame: At the Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 meter Backward Test (time frame: At the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.