Knee OsteoarthritisNCT06202170
Validity and Reliability of 30SFPW Test Patients With TKA
An observational study of Knee Osteoarthritis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Walking speed after total knee arthroplasty (TKA) can be used as a simple tool to monitor postoperative recovery. There are different protocols for gait assessment in patients with TKA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 30 Dec 2023
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who had primary TKA surgery at least six months ago
Inclusion Criteria:patients who had primary TKA surgery at least six months ago, being diagnosed with preoperative knee OA, and volunteering to participate in the research -
Exclusion Criteria:had a previous orthopedic, neurological, or systemic disease that effects walking or standing, body mass index of 40 kg / m2 and over, having any other surgery on the same limb that effect walking, and revision TKA.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Validity and Reliability of the 30-Second Fast-Paced Walk Test in Patients With Total Knee Arthroplasty
Walking speed after total knee arthroplasty (TKA) can be used as a simple tool to monitor postoperative recovery. There are different protocols for gait assessment in patients with TKA. The 30 Second Fast Walk Test (30SFW) is a simple, low-cost and easy-to-apply assessment method that requires very little equipment in clinical settings. 30SFW is a reliable, valid test of walking ability in patients with knee osteoarthritis (OA).
Objective: To investigate the reliability and validity of the 30SFW test in the evaluation of gait in patients with TKA.
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, knee, 30-Second Fast-Paced Walk Test, validity, reliability.
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
30SFPWT
30 Second Fast-Paced Walk Test
Measured: 1 Hour-30 Seconds
Secondary outcomes (2)
Hss Knee Socre
Measured: 15 minutes
SF-12 Quality Life Score
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start2 Jan 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
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
- 38 participants (actual)
- Target duration
- 1 Day
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
- NCT06202170
- Sponsor's protocol ID
- 6748-GOA
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the 30-Second Fast-Paced Walk Test in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06202170
- Acronym / sponsor ID
- 6748-GOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, knee, 30-Second Fast-Paced Walk Test, validity, reliability.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 11 Jan 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.
Walking speed after total knee arthroplasty (TKA) can be used as a simple tool to monitor postoperative recovery. There are different protocols for gait assessment in patients with TKA. The 30 Second Fast Walk Test (30SFW) is a simple, low-cost and easy-to-apply assessment method that requires very little equipment in clinical settings. 30SFW is a reliable, valid test of walking ability in patients with knee osteoarthritis (OA).
Objective: To investigate the reliability and validity of the 30SFW test in the evaluation of gait in patients with TKA.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who had primary TKA surgery at least six months ago
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
30SFPWT
Time frame: 1 Hour-30 Seconds
30 Second Fast-Paced Walk Test
2 secondary outcomes
Hss Knee Socre
Time frame: 15 minutes
SF-12 Quality Life Score
Time frame: 15 minutes
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 11 Jan 2024.
- Individual participant dataSharing planned: No
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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 Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. 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?
30SFPWT (time frame: 1 Hour-30 Seconds). 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 11 Jan 2024.