TelerehabilitationTeleassessmentNCT06711445
Tele-assessment of the Performance Tests in Patients With Knee Osteoarthritis
An observational study of Telerehabilitation and Tele-assessment, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The COVID-19 pandemic widely affected delivery mode of healthcare services. While fewer number of patients were allowed to attend face-to-face rehabilitation sessions, some services were totally unavailable due to the safety measures. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Telerehabilitation, Tele-assessment, Knee Arthritis Osteoarthritis
- What is being tested?
- Tele-assessment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 10 Nov 2021
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We used convenience sampling method to recruit patients diagnosed with knee OA by their medical doctor according to the guidelines of American College of Rheumatology (ACR).
Who may be able to join
- Grade 2 and 3 knee OA on the Kellgren and Lawrence (K/L) scale,
- radiologically confirmed
- pain in the knee,
- willingness to join the study
Who cannot join
- Grade 0, 1 and 4 knee OA on the K/L scale,
- central or peripheral nervous system involvement,
- previous knee surgery within the past six months,
- neurological or musculoskeletal disorders that would limit their performance on the tests,
- history of systemic arthritic conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Health Sciences
Konya, 42130
About this study
Official title: Reliability of Tele-assessment of the Performance Tests in Patients With Knee Osteoarthritis
The COVID-19 pandemic widely affected delivery mode of healthcare services. While fewer number of patients were allowed to attend face-to-face rehabilitation sessions, some services were totally unavailable due to the safety measures. The COVID-19 crisis highlighted the value and accelerated the improvement of "tele-assessment and tele-rehabilitation" applications. Consequently, reliable remote assessment approaches were required to evaluate the effectiveness of the remote programs. While tests such as TUG, SLS, and 30CST are valid and reliable for clinical use in patients with knee OA, their psychometric properties are yet to be investigated when used as tele-assessment tests. Therefore, this study aimed to examine the intra- and inter-rater reliability of the TUG, SLS, and 30CST as remote tests in patients with knee OA.
Read the detailed description
As the main cause of disability and loss of function in lower limb in middle-aged to elderly individuals , knee osteoarthritis (OA) is the most common OA worldwide and its prevalence increases with age and obesity . Among non-pharmacological methods, which are the first line of knee OA treatment , physical therapy is commonly prescribed to alleviate pain and improve physical function. However, not all patients with knee OA have access to face-to-face rehabilitation sessions under direct supervision of physicians or physiotherapists. Thanks to telemedicine, patients' access to real-time communication with health professionals has been considerably facilitated in recent years.
Detailed and comprehensive assessment is a fundamental factor for an effective rehabilitation program. Different assessment tools are available to assess the effectiveness of rehabilitation in patients with knee OA. To assess physical performance, practical tests, which are time- and space-effective, such as Timed Up and Go Test (TUG), Thirty Second Chair Stand Test (30CST), and Single Leg Stance Test (SLS) are commonly used in patients with knee OA .COVID-19 crisis highlighted the value and accelerated the improvement of "tele-assessment and tele-rehabilitation" applications. Consequently, reliable remote assessment approaches were required to evaluate the effectiveness of the remote programs.
- Being tested
- Tele-assessment
- Keywords
- Knee osteoarthritis, reliability, single leg stance test, tele-assessment, thirty second chair stand test, timed up and go 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.
Tele-assessmentOther
The participants were evaluated in two settings on different days (24-48 h apart): (i) in clinical settings (face-to-face) and (ii) at home via 'WhatsApp' phone application (both asynchronized and synchronized tele-assessment).
The evaluations steps were as follows:
- Face-to-face/ Clinic assessment: Rater 1 completed all clinical assessments.
- Synchronized tele-assessment: Rater 1 repeated the same evaluations via video calls to the patients (these were recorded to be used in step 3).
- Asynchronized tele-assessment: Rater 2 evaluated the recordings of the remote evaluations (made in step 2).
- Retest of synchronized tele-assessment: Rater 1 evaluated patients via video calls (these were recorded to be used in step 5).
- Retest of asynchronized tele-assessment: Rater 2 evaluated the recordings of the remote evaluations (made in step 4).
| Study group | Role | What they receive |
|---|---|---|
| Tele- assessment Group | The participants were evaluated in two settings on different days (24-48 h apart): (i) in clinical settings (face-to-face) and (ii) at home via 'WhatsApp' phone application (both asynchronized and synchronized tele-assessment). Receives: Other: Tele-assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test (TUG)
The TUG is a simple practical test that measures the time an individual needs to stand up from a standard chair, walk 3 meters at normal speed, turn around, walk back to the chair, and sit down. Our participants performed 3 trials and their best score (in seconds) was recorded as the primary outcome. Participants had at least 4 minutes of seated rest intervals between the trials. Before and after each test, fatigue and dyspnea (using Borg scale), and hemodynamic (heart rate and SpO2) were evaluated.
Measured: 2 days
Single Leg Stance Test (SLS)
The participants used their leg with arthritic knee (in cases of unilateral involvement) or the more symptomatic leg (in cases of bilateral involvement) as the stance limb. The test was terminated when the free leg/foot touched the ground, or if excessive trunk/upper body movements (e.g., swinging arms) were observed. Participants were allowed to repeat the test if they scored less than10 seconds during the first attempt. If needed, participants could rest between the trials for recovery. Before and after each test, fatigue and dyspnea (using Borg scale), and hemodynamics (heart rate and SpO2) were evaluated.
Measured: 2 days
Thirty second chair stand test (30 CST)
The 30 CST checks the number of repetitions in 30 seconds that an individual can stand up from a standard chair (not using the arms/hands, feet flat on the ground) and sit back again. Our test chair was 43 cm in height and had no armrest. The participants performed 3 trials and their best score was recorded as the test result. If needed, they were allowed to rest (>5 min) between the trials for recovery. Before and after each test, fatigue and dyspnea (using Borg scale), and hemodynamics (heart rate and SpO2) were evaluated.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start15 Nov 2020
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşah ÖZSOY, Selcuk University
- Investigators
- Gulsah Ozsoy, PhD, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711445
- Sponsor's protocol ID
- SELCUKU_PT_GO_001
- Acronym
- Teleassessment
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Takacs J, Carpenter MG, Garland SJ, Hunt MA. Test re-test reliability of centre of pressure measures during standing balance in individuals with knee osteoarthritis. Gait Posture. 2014;40(1):270-3. doi: 10.1016/j.gaitpost.2014.03.016. Epub 2014 Mar 27.
PubMed 24746407Gill S, Hely R, Page RS, Hely A, Harrison B, Landers S. Thirty second chair stand test: Test-retest reliability, agreement and minimum detectable change in people with early-stage knee osteoarthritis. Physiother Res Int. 2022 Jul;27(3):e1957. doi: 10.1002/pri.1957. Epub 2022 May 19.
PubMed 35592902Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
PubMed 26223312Hatfield GL, Morrison A, Wenman M, Hammond CA, Hunt MA. Clinical Tests of Standing Balance in the Knee Osteoarthritis Population: Systematic Review and Meta-analysis. Phys Ther. 2016 Mar;96(3):324-37. doi: 10.2522/ptj.20150025. Epub 2015 Jul 16.
PubMed 26183586French HP, Hager CK, Venience A, Fagan R, Meldrum D. Psychometric properties and domains of postural control tests for individuals with knee osteoarthritis: a systematic review. Int J Rehabil Res. 2020 Jun;43(2):102-115. doi: 10.1097/MRR.0000000000000403.
PubMed 32282571
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Tele-assessment of the Performance Tests in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06711445
- Acronym / sponsor ID
- Teleassessment / SELCUKU_PT_GO_001
- Keywords
- Knee osteoarthritis, reliability, single leg stance test, tele-assessment, thirty second chair stand test, timed up and go test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 2 Dec 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.
The COVID-19 pandemic widely affected delivery mode of healthcare services. While fewer number of patients were allowed to attend face-to-face rehabilitation sessions, some services were totally unavailable due to the safety measures. The COVID-19 crisis highlighted the value and accelerated the improvement of "tele-assessment and tele-rehabilitation" applications. Consequently, reliable remote assessment approaches were required to evaluate the effectiveness of the remote programs. While tests such as TUG, SLS, and 30CST are valid and reliable for clinical use in patients with knee OA, their psychometric properties are yet to be investigated when used as tele-assessment tests. Therefore, this study aimed to examine the intra- and inter-rater reliability of the TUG, SLS, and 30CST as remote tests in patients with knee OA.
Detailed description
As the main cause of disability and loss of function in lower limb in middle-aged to elderly individuals , knee osteoarthritis (OA) is the most common OA worldwide and its prevalence increases with age and obesity . Among non-pharmacological methods, which are the first line of knee OA treatment , physical therapy is commonly prescribed to alleviate pain and improve physical function. However, not all patients with knee OA have access to face-to-face rehabilitation sessions under direct supervision of physicians or physiotherapists. Thanks to telemedicine, patients' access to real-time communication with health professionals has been considerably facilitated in recent years.
Detailed and comprehensive assessment is a fundamental factor for an effective rehabilitation program. Different assessment tools are available to assess the effectiveness of rehabilitation in patients with knee OA. To assess physical performance, practical tests, which are time- and space-effective, such as Timed Up and Go Test (TUG), Thirty Second Chair Stand Test (30CST), and Single Leg Stance Test (SLS) are commonly used in patients with knee OA .COVID-19 crisis highlighted the value and accelerated the improvement of "tele-assessment and tele-rehabilitation" applications. Consequently, reliable remote assessment approaches were required to evaluate the effectiveness of the remote programs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele- assessment Group | – | Other: Tele-assessmentThe participants were evaluated in two settings on different days (24-48 h apart): (i) in clinical settings (face-to-face) and (ii) at home via 'WhatsApp' phone application (both asynchronized and synchronized tele-assessment). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We used convenience sampling method to recruit patients diagnosed with knee OA by their medical doctor according to the guidelines of American College of Rheumatology (ACR).
Key inclusion criteria (4 listed)
- Grade 2 and 3 knee OA on the Kellgren and Lawrence (K/L) scale,
- radiologically confirmed
- pain in the knee,
- willingness to join the study
Key exclusion criteria (5 listed)
- Grade 0, 1 and 4 knee OA on the K/L scale,
- central or peripheral nervous system involvement,
- previous knee surgery within the past six months,
- neurological or musculoskeletal disorders that would limit their performance on the tests,
- history of systemic arthritic conditions
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 |
|---|---|---|
| Tele-assessmentThe participants were evaluated in two settings on different days (24-48 h apart): (i) in clinical settings (face-to-face) and (ii) at home via 'WhatsApp' phone application (both asynchronized and synchronized tele-assessment). The evaluations steps were as follows: 1. Face-to-face/ Clinic assessment: Rater 1 completed all clinical assessments. 2. Synchronized tele-assessment: Rater 1 repeated the same evaluations via video calls to the patients (these were recorded to be used in step 3). 3. Asynchronized tele-assessment: Rater 2 evaluated the recordings of the remote evaluations (made in step 2). 4. Retest of synchronized tele-assessment: Rater 1 evaluated patients via video calls (these were recorded to be used in step 5). 5. Retest of asynchronized tele-assessment: Rater 2 evaluated the recordings of the remote evaluations (made in step 4). | Other | Tele- assessment Group |
Primary outcome
Timed up and go test (TUG)
Time frame: 2 days
The TUG is a simple practical test that measures the time an individual needs to stand up from a standard chair, walk 3 meters at normal speed, turn around, walk back to the chair, and sit down. Our participants performed 3 trials and their best score (in seconds) was recorded as the primary outcome. Participants had at least 4 minutes of seated rest intervals between the trials. Before and after each test, fatigue and dyspnea (using Borg scale), and hemodynamic (heart rate and SpO2) were evaluated.
Single Leg Stance Test (SLS)
Time frame: 2 days
The participants used their leg with arthritic knee (in cases of unilateral involvement) or the more symptomatic leg (in cases of bilateral involvement) as the stance limb. The test was terminated when the free leg/foot touched the ground, or if excessive trunk/upper body movements (e.g., swinging arms) were observed. Participants were allowed to repeat the test if they scored less than10 seconds during the first attempt. If needed, participants could rest between the trials for recovery. Before and after each test, fatigue and dyspnea (using Borg scale), and hemodynamics (heart rate and SpO2) were evaluated.
Thirty second chair stand test (30 CST)
Time frame: 2 days
The 30 CST checks the number of repetitions in 30 seconds that an individual can stand up from a standard chair (not using the arms/hands, feet flat on the ground) and sit back again. Our test chair was 43 cm in height and had no armrest. The participants performed 3 trials and their best score was recorded as the test result. If needed, they were allowed to rest (>5 min) between the trials for recovery. Before and after each test, fatigue and dyspnea (using Borg scale), and hemodynamics (heart rate and SpO2) were evaluated.
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 2 Dec 2024.
- Background: PubMed 24746407Takacs J, Carpenter MG, Garland SJ, Hunt MA. Test re-test reliability of centre of pressure measures during standing balance in individuals with knee osteoarthritis. Gait Posture. 2014;40(1):270-3. doi: 10.1016/j.gaitpost.2014.03.016. Epub 2014 Mar 27.
- Background: PubMed 35592902Gill S, Hely R, Page RS, Hely A, Harrison B, Landers S. Thirty second chair stand test: Test-retest reliability, agreement and minimum detectable change in people with early-stage knee osteoarthritis. Physiother Res Int. 2022 Jul;27(3):e1957. doi: 10.1002/pri.1957. Epub 2022 May 19.
- Background: PubMed 26223312Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
- Background: PubMed 26183586Hatfield GL, Morrison A, Wenman M, Hammond CA, Hunt MA. Clinical Tests of Standing Balance in the Knee Osteoarthritis Population: Systematic Review and Meta-analysis. Phys Ther. 2016 Mar;96(3):324-37. doi: 10.2522/ptj.20150025. Epub 2015 Jul 16.
- Background: PubMed 32282571French HP, Hager CK, Venience A, Fagan R, Meldrum D. Psychometric properties and domains of postural control tests for individuals with knee osteoarthritis: a systematic review. Int J Rehabil Res. 2020 Jun;43(2):102-115. doi: 10.1097/MRR.0000000000000403.
- 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.
Gulsah Ozsoy, PhD study chair
Selcuk University
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 Telerehabilitation and Tele-assessment, run by Selcuk 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 5 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 2 Dec 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?
Timed up and go test (TUG) (time frame: 2 days). The study lists 3 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 NCT06711445, which also lists 5 linked publications.
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 2 Dec 2024.