Total Knee Arthroplasty RecoveryNCT07834229
Telerehabilitation Versus Clinic-Based Rehabilitation for Functional Recovery Following Primary Total Knee Arthroplasty
A study testing Rehabilitation treatment sessions focussing on education and exercise prescription. in people with Total Knee Arthroplasty Recovery and Total Knee Replacement, run by The University of Western Australia at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty Recovery, Total Knee Replacement, Total Knee Arthroplasty\(TKA\)
- What is being tested?
- Rehabilitation treatment sessions focussing on education and exercise prescription.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Sep 2020to 31 Aug 2022
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing primary elective TKA for the treatment of end stage knee OA
- ability to independently provide informed consent
- a willingness to attend all rehabilitation sessions and assessment time points, irrespective of the delivery
Who cannot join
- comorbidities preventing participation in rehabilitation (e.g., severe obstructive pulmonary disease, hemiplegia)
- revision TKA
- intra-operative complications precluding rehabilitation
- likely difficulties with follow-up
- inability to read or speak English
- unable to attend in person clinic visits due to travel distance
- unwillingness to comply with the rehabilitation protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Comparison of Clinic- Versus Telehealth-delivered Early-stage Post-operative Rehabilitation and Functional Assessment Following Total Knee Arthroplasty.
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:
- Does rehabilitation by video call lead to knee-related quality of life that is just as good as rehabilitation completed in person at a clinic?
Read more
Researchers will compare a telehealth group to a clinic group to see if telehealth rehabilitation works as well as in-person rehabilitation.
Participants will:
- Take part in 9 rehabilitation sessions over 6 weeks, either by video call from home or in person at a clinic
- Follow a home exercise program using an online app
- Answer questions about their knee and daily activities before surgery, and again at 7 weeks, 6 months, and 12 months after surgery
- Have their knee movement and physical abilities, such as walking speed and climbing stairs, measured by a therapist before surgery, and again at 7 weeks, and 12 months after surgery
Read the detailed description
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.
- Conditions
- Total Knee Arthroplasty Recovery, Total Knee Replacement, Total Knee Arthroplasty\(TKA\), Knee Arthritis Osteoarthritis, Knee Range of Motion, Telehealth
- Being tested
- Rehabilitation treatment sessions focussing on education and exercise prescription.
- Keywords
- Total Knee Arthroplasty, TKA, Telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation treatment sessions focussing on education and exercise prescription.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | Treatment sessions were delivered and supervised remotely using telerehabilitation technology. Receives: Behavioral: Rehabilitation treatment sessions focussing on education and exercise prescription. |
| Clinic Group | Active comparator | Treatment sessions were delivered in-person at a single private rehabilitation clinic. Receives: Behavioral: Rehabilitation treatment sessions focussing on education and exercise prescription. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Timed Up and Go (TUG) Test
Measured: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
30-Second Sit-to-Stand (STS) Test
Measured: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
40m Fast-Paced Walk Test (FPWt)
Measured: Pre-operative, 7 weeks post-surgery, and 12 months post-surgery
9-Step Stair Climb Test (SCT)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start16 Sep 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty RecoveryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray Seaby, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834229
- Sponsor's protocol ID
- (RA/4/20/6103)
- Other IDs
- CRCPSIX000203
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No