Knee Injuries and DisordersDT TKANCT06108466
RELIABILITY AND VALIDITY OF THE DT BALANCE TEST IN PATIENTS WITH TKA
An observational study of Knee Injuries and Disorders and Osteo Arthritis Knee, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The ability to perform a cognitive task while walking simultaneously is essential in real daily life. However, the psychometric properties of dual-task walking tests have not been well established in patients undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Knee Injuries and Disorders, Osteo Arthritis Knee
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2022to 25 Nov 2023
- 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 Up to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Total Knee arthroplasty
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RELIABILITY AND VALIDITY OF THE DUAL TASK BALANCE TEST IN PATIENTS WITH TOTAL KNEE ARTHROPLASTY
The ability to perform a cognitive task while walking simultaneously is essential in real daily life. However, the psychometric properties of dual-task walking tests have not been well established in patients undergoing total knee arthroplasty (TKA). The aim of study assess the test-retest reliability and validity of dual conditions TUG, 3MBWT, 8FWT nad 4SST in patients with TKA.
- Conditions
- Knee Injuries and Disorders, Osteo Arthritis Knee
- Keywords
- Total Knee Arthroplasty, dual test,, timed up and go, reliability
- Medical subject headings
- Knee Injuries, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance test
Timed Up and Go Test
Measured: 1 Hour
Performance Test
3MWT
Measured: 1 hour
Perfromance Test
8 FWT
Measured: 1 hour
Performance Test
4SST
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start14 Jan 2022
- Primary completion12 Nov 2023 (estimated)
- Study completion25 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Injuries and DisordersStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Ozcan, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108466
- Sponsor's protocol ID
- 6749-GOA
- Acronym
- DT TKA
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozcan D, Unver B, Karatosun V. Balance assessment under dual task conditions in patients with total knee arthroplasty: a test-retest reliability and concurrent validity study. Physiother Theory Pract. 2025 Jan;41(1):93-98. doi: 10.1080/09593985.2024.2321222. Epub 2024 Feb 21.
PubMed 38384122
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIABILITY AND VALIDITY OF THE DUAL TASK BALANCE TEST IN PATIENTS WITH TOTAL KNEE ARTHROPLASTY
- ClinicalTrials.gov ID
- NCT06108466
- Acronym / sponsor ID
- DT TKA / 6749-GOA
- Conditions
- Knee Injuries and Disorders, Osteo Arthritis Knee
- Keywords
- Total Knee Arthroplasty, dual test,, timed up and go, reliability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 12 Nov 2023 (estimated)
- Study completion
- 25 Nov 2023 (estimated)
- First posted
- 31 Oct 2023 (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.
The ability to perform a cognitive task while walking simultaneously is essential in real daily life. However, the psychometric properties of dual-task walking tests have not been well established in patients undergoing total knee arthroplasty (TKA). The aim of study assess the test-retest reliability and validity of dual conditions TUG, 3MBWT, 8FWT nad 4SST in patients with TKA.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Total Knee arthroplasty
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance test
Time frame: 1 Hour
Timed Up and Go Test
Performance Test
Time frame: 1 hour
3MWT
Perfromance Test
Time frame: 1 hour
8 FWT
Performance Test
Time frame: 1 hour
4SST
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 38384122Ozcan D, Unver B, Karatosun V. Balance assessment under dual task conditions in patients with total knee arthroplasty: a test-retest reliability and concurrent validity study. Physiother Theory Pract. 2025 Jan;41(1):93-98. doi: 10.1080/09593985.2024.2321222. Epub 2024 Feb 21.
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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 Injuries and Disorders and Osteo Arthritis Knee, run by Dokuz Eylul 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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
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?
Performance test (time frame: 1 Hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108466, which also lists 1 linked publication.
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 31 Oct 2023.