Knee OsteoarthritisNCT06201637
Validity And Reliability Of The Short Physical Performance Battery In Patients Undergoing Total Knee Arthroplasty
A study testing Performance Test in people with Knee Osteoarthritis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: Practical, applicable, valid, and reliable tools are needed to assess physical performance in patients with Total Knee Arthroplasty(TKA) in a variety of settings, including routine clinical assessment, research studies, and community-based programs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Performance Test
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2022to 12 Feb 2023
- Phase
- Interventional
- 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
Who may be able to join
- patients who had primary TKA surgery at six months ago, were diagnosed with preoperative knee OA, and were willing to participate in the research
Who cannot join
- a previous orthopedic, neurological, or systemic disease that effected walking or standing, body mass index of 40 kg / m2 and over and having any other surgery on the same limb that effected walking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation Of The Validity And Reliability Of The Short Physical Performance Battery In Patients Undergoing Total Knee Arthroplasty
Objectives: Practical, applicable, valid, and reliable tools are needed to assess physical performance in patients with Total Knee Arthroplasty(TKA) in a variety of settings, including routine clinical assessment, research studies, and community-based programs. Therefore, the aim of this study is to evaluate the validity and reliability of the Short Physical Performance Battery (SPPB) among patients with TKA.
Methods: We included patients who underwent TKA surgery. The SPPB, Timed up and go(TUG) test and, Hospital for Special Surgery (HSS) Knee Score were administered to the patients. SPPB was performed twice on the same day with 1 h rest.
- Conditions
- Knee Osteoarthritis
- Being tested
- Performance Test
- Keywords
- Total knee arthroplasty, knee, Short Physical Performance Battery, validity, reliability
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance TestOther
Performance Test
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
Measured: 1 Hour
Secondary outcomes (1)
TUG
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 2022
- Primary completion12 Feb 2023
- Study completion12 Feb 2023
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT06201637
- Sponsor's protocol ID
- 6784-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
Publications
Ozcan D, Unver B, Karatosun V. Investigation of the validity and reliability of the short physical performance battery in patients undergoing total knee arthroplasty. Physiother Theory Pract. 2025 Feb;41(2):370-376. doi: 10.1080/09593985.2024.2337784. Epub 2024 Apr 1.
PubMed 38557264
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
- Investigation Of The Validity And Reliability Of The Short Physical Performance Battery In Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06201637
- Acronym / sponsor ID
- 6784-GOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, knee, Short Physical Performance Battery, validity, reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 12 Feb 2023 (actual)
- Study completion
- 12 Feb 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.
Objectives: Practical, applicable, valid, and reliable tools are needed to assess physical performance in patients with Total Knee Arthroplasty(TKA) in a variety of settings, including routine clinical assessment, research studies, and community-based programs. Therefore, the aim of this study is to evaluate the validity and reliability of the Short Physical Performance Battery (SPPB) among patients with TKA.
Methods: We included patients who underwent TKA surgery. The SPPB, Timed up and go(TUG) test and, Hospital for Special Surgery (HSS) Knee Score were administered to the patients. SPPB was performed twice on the same day with 1 h rest.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who had primary TKA surgery at six months ago, were diagnosed with preoperative knee OA, and were willing to participate in the research
Key exclusion criteria (1 listed)
- a previous orthopedic, neurological, or systemic disease that effected walking or standing, body mass index of 40 kg / m2 and over and having any other surgery on the same limb that effected walking.
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 |
|---|---|---|
| Performance TestPerformance Test | Other | – |
Primary outcome
Short Physical Performance Battery
Time frame: 1 Hour
1 secondary outcome
TUG
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.
- Derived from this study: PubMed 38557264Ozcan D, Unver B, Karatosun V. Investigation of the validity and reliability of the short physical performance battery in patients undergoing total knee arthroplasty. Physiother Theory Pract. 2025 Feb;41(2):370-376. doi: 10.1080/09593985.2024.2337784. Epub 2024 Apr 1.
- 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?
A study testing Performance Test in people with 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.
Who may be eligible to take part?
The sponsor lists 1 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: 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?
Short Physical Performance Battery (time frame: 1 Hour). 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 NCT06201637, 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 11 Jan 2024.