An interventional study of Rehabilitation treatment sessions focussing on education and exercise prescription. in Total Knee Arthroplasty Recovery, Total Knee Replacement and Total Knee Arthroplasty\(TKA\), sponsored by The University of Western Australia. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by The University of Western Australia · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine if rehabilitation delivered by telehealth works as well as rehabilitation delivered in person at a clinic, for people recovering from total knee replacement surgery. The main question it aims to answer is:
Researchers will compare a telehealth group to a clinic group to see if telehealth rehabilitation works as well as in-person rehabilitation.
Participants will:
This randomised controlled, single-blinded, non-inferiority trial compared telehealth-delivered versus clinic-based (in-person) early-stage rehabilitation following primary total knee arthroplasty (TKA).
Following written informed consent and pre-operative baseline assessment, participants were randomised to either a Telerehabilitation or Clinic group using a computer-generated sequence, with allocation concealed by an independent researcher. The primary outcome assessor remained blinded to group allocation throughout the study.
Both groups received an identical rehabilitation protocol comprising nine supervised sessions delivered over a 6-week post-operative period (twice weekly for the first three weeks, followed by once weekly for a further three weeks), commencing 4-7 days after surgery. Each session lasted approximately 30 minutes and was delivered by Accredited Exercise Physiologists. Sessions addressed pain and swelling management, safe and progressive ambulation, activities of daily living, review and progression of a structured Home Exercise Program (HEP), and monitoring of knee range of motion.
The Clinic group attended sessions in person at a single private rehabilitation clinic. The Telerehabilitation group received the same sessions remotely via a telehealth platform (Coviu, Sydney, Australia). Both groups were provided the HEP through an online exercise-delivery platform (Physitrack, Physitrack Ltd., London, UK), which included video-based exercise demonstrations, adherence monitoring, and secure patient-provider messaging. HEP frequency and intensity were progressively modified over the 6-week program according to individual pain tolerance, knee range of motion progression, and treating therapist judgement.
Outcome assessments were conducted pre-operatively and at 7 weeks (following completion of the rehabilitation intervention), and at 6 and 12 months post-surgery. All in-person clinical assessments were conducted by a single therapist who remained blinded to group allocation.
The study hypothesis was that telerehabilitation would be non-inferior to clinic-based rehabilitation with respect to the primary outcome measure, with no clinically meaningful differences expected between groups in secondary patient-reported outcomes, active knee range of motion, or objective measures of lower-limb function.
Sample size was calculated to detect non-inferiority at the 7-week timepoint, using a non-inferiority margin of 10 points (based on the published minimal clinically important difference for the primary outcome measure), an assumed standard deviation of 12.5 points, an alpha level of 0.05, and 90% power. This yielded a requirement of 42 participants per group, increased to 54 per group (108 total) to allow for an anticipated 25% loss to follow-up. Both intention-to-treat and as-treated analyses were performed in accordance with CONSORT guidelines for non-inferiority trials.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 108 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →The University of Western Australia is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment sessions were delivered and supervised remotely using telerehabilitation technology.
Behavioral: Rehabilitation treatment sessions focussing on education and exercise prescription.
Treatment sessions were delivered in-person at a single private rehabilitation clinic.
Behavioral: Rehabilitation treatment sessions focussing on education and exercise prescription.
Both arms of the study received an identical rehabilitation protocol comprising nine supervised sessions delivered over a 6-week post-operative period (twice weekly for the first three weeks, followed by once weekly for a further three weeks), commencing 4-7 days after surgery. Each session lasted approximately 30 minutes and was delivered by Accredited Exercise Physiologists. Both groups were provided Home Exercise Programs (HEP) via an online platform.
Knee-Related Quality of Life (QOL) subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS-QOL is a 4-item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that assesses knee-related quality of life. Scores range from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates no knee-related problems. Higher scores indicate better knee-related quality of life.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Pain subscale (KOOS-PAIN) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS-PAIN is a 9-item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that assesses knee-related quality of life. Scores range from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates no knee-related problems. Higher scores indicate better knee-related quality of life.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Symptom subscale (KOOS-SYMPTOM) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS-SYMPTOM is a 7-item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that assesses knee-related quality of life. Scores range from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates no knee-related problems. Higher scores indicate better knee-related quality of life.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Activity of Daily Living (KOOS-ADLs) subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS-ADLs is a 17-item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that assesses knee-related quality of life. Scores range from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates no knee-related problems. Higher scores indicate better knee-related quality of life.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Sport and Recreation subscale (KOOS-Sport and Recreation) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS-Sport and Recreation is a 5-item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that assesses knee-related quality of life. Scores range from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates no knee-related problems. Higher scores indicate better knee-related quality of life.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Active knee flexion range of movement (ROM)
Range of movement will be measures using a standard, hand-held goniometer
Time frame: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
Active knee extension range of movement (ROM)
Range of movement will be measures using a standard, hand-held goniometer
Time frame: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
Visual Analogue Scale for Pain Severity (VAS-S)
Visual Analogue Scale (VAS) for Pain Severity is a single-item measure of pain intensity. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
University of California, Los Angeles (UCLA) activity scale
The University of California, Los Angeles (UCLA) Activity Scale assesses physical activity and functional activity levels. Scores range from 1 to 10, where 1 represents complete inactivity and dependence on others and 10 represents regular participation in impact sports. Higher scores indicate greater activity levels and better function.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Timed Up and Go (TUG) Test
Time frame: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
30-Second Sit-to-Stand (STS) Test
Time frame: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
40m Fast-Paced Walk Test (FPWt)
Time frame: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
9-Step Stair Climb Test (SCT)
Time frame: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
Global Rating of Change (GRC)
The Global Rating of Change (GRC) assesses participants' perceived change in their knee condition over time. Scores range from -5 to +5, where negative scores indicate worsening, 0 indicates no change, and positive scores indicate improvement. Higher scores indicate greater perceived improvement.
Time frame: 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Self-Administered Patient Satisfaction Scale (SAPS)
The Self-Administered Patient Satisfaction Scale (SAPS) assesses patient satisfaction with treatment outcomes, including pain relief and functional improvement. Each item is scored on a 4-point ordinal scale ranging from 1 to 4, where 1 indicates Very Satisfied, 2 indicates Somewhat Satisfied, 3 indicates Somewhat Dissatisfied, and 4 indicates Very Dissatisfied. Lower scores indicate greater patient satisfaction, whereas higher scores indicate greater dissatisfaction.
Time frame: 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a self-reported measure of health-related quality of life across eight domains, including physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional wellbeing, and mental health. Scores range from 0 to 100 for each domain, where 0 indicates the poorest health status and 100 indicates the best possible health status. Higher scores indicate better health-related quality of life.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
e-Health Literacy Assessment Toolkit (eHLA)
The eHealth Literacy Assessment Toolkit (eHLA) assesses participants' familiarity with digital technologies, confidence using digital technologies, and attitudes towards digital devices. Responses are scored on 4-point Likert scales ranging from 1 to 4.Higher scores indicate greater digital literacy, confidence, and engagement with digital technologies.
Time frame: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The University of Western Australia