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Completed

NCT Number: NCT06711445

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University, Faculty of Health Sciences

Konya, 42130, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-assessment

Other

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Reliability of Tele-assessment of the Performance Tests in Patients With Knee Osteoarthritis

Acronym: Teleassessment

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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