- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06711445
Tele-assessment of the Performance Tests in Patients With Knee Osteoarthritis (Teleassessment)
Reliability of Tele-assessment of the Performance Tests in Patients With Knee Osteoarthritis
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Konya, Turkey, 42130
- Selcuk University, Faculty of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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).
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Timed up and go test (TUG)
Time Frame: 2 days
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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.
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2 days
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Single Leg Stance Test (SLS)
Time Frame: 2 days
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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.
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2 days
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Thirty second chair stand test (30 CST)
Time Frame: 2 days
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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.
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2 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gulsah Ozsoy, PhD, Selcuk University
Publications and helpful links
General Publications
- Alghadir 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.
- 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.
- Gill 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.
- Hatfield 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.
- French 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SELCUKU_PT_GO_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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