NCT06711445

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

November 22, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

Knee osteoarthritisreliabilitysingle leg stance testtele-assessmentthirty second chair stand testtimed up and go test

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    2 days

Study Arms (1)

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).

Other: Tele-assessment

Interventions

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: 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).

Tele- assessment Group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Faculty of Health Sciences

Konya, 42130, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 24746407BACKGROUND
  • 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.

    PMID: 35592902BACKGROUND
  • 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.

    PMID: 26223312BACKGROUND
  • 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.

    PMID: 26183586BACKGROUND
  • 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.

    PMID: 32282571BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Gulsah Ozsoy, PhD

    Selcuk University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 22, 2024

First Posted

December 2, 2024

Study Start

November 15, 2020

Primary Completion

November 10, 2021

Study Completion

November 10, 2021

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations