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A comparison of clinic-delivered and telehealth-delivered post-operative rehabilitation and functional assessment following total knee arthroplasty

A comparison of clinic-delivered and telehealth-delivered post-operative rehabilitation programs, assessing range of motion and function outcomes, following total knee arthroplasty,

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001168943
Enrollment
109
Registered
2020-11-06
Start date
2020-09-16
Completion date
2022-03-31
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A randomised, single-blinded, controlled, non-inferiority clinical trial comparing a technology-based, remotely delivered ("Telehealth group") TKR rehabilitation program to usual, in-person care ("Clinic group"). 150 participants who are scheduled to undergo primary elective total knee replacement will be recruited over a period of 10 months with 75 participants randomly allocated to each arm of the study. Participants allocated to both arms of the study will complete 6 weeks of post-surgery exercise rehabilitation (twice per week for three weeks, then once per week for the next three weeks). Primary outcome measures are 'knee flexion range of motion' (ROM) and the 'Knee Injury and Osteoarthritis Outcome Score' (KOOS). Secondary patient reported outcomes include Visual Analogue Scale, Short Form Health Survey (Sf-36), Global Rating of Change, Patient Satisfaction and the Telehealth Digital Literacy Questionnaire. Secondary functional assessments include 40meter Fast Paced Walk Test, 30 Second Sit to Stand Test, Stair Climb Test (9 stairs) and the Timed Up and Go Test. Participants from both groups will have outcome measures collected in an in-person assessment: pre-surgery, 7 weeks post-surgery (+7 weeks), and at 12 months post-surgery (+12 months). Online questionnaires only will be send at 6 months post-surgery (+6 months). This study aims to: 1. Determine if short- and medium-term outcomes for TKR patients are similar following a 6-week rehabilitation delivered either via telehealth or within a clinic setting (in-person). 2. Assess the economic costs of rehabilitation delivered in each of these modes. 3. Determine whether knee joint range of motion (ROM) can be assessed both practically and accurately via telehealth.

Interventions

All patients (>18 years of age) scheduled for primary TKR from the public and private lists of approximately five surgeons will be identified and their potential involvement in this project made known. If agreeable, a follow-up contact will be made by the study coordinator where details of the study and participant involvement will be discussed. Consenting patients will then be scheduled for a pre-surgery clinic visit to have preoperative outcome measures collected. Patients will formally enter

All patients (>18 years of age) scheduled for primary TKR from the public and private lists of approximately five surgeons will be identified and their potential involvement in this project made known. If agreeable, a follow-up contact will be made by the study coordinator where details of the study and participant involvement will be discussed. Consenting patients will then be scheduled for a pre-surgery clinic visit to have preoperative outcome measures collected. Patients will formally enter the study and be randomised to one of two study arms. Study arm 1: Clinic Group On discharge from hospital, participants who are allocated to the Clinic Group will attend a rehabilitation clinic for treatment sessions during their first 6 weeks following surgery (twice per week for three weeks, then once per week for the next three weeks). The first session is expected to occur approximately one week following the surgery date (+1 week). Each session will be led by an Accredited Exercise Physiologist (AEP) and consist of 30-minute face-to-face exercise rehabilitation session, with a focus on reviewing their home exercise program (HEP), and measuring their knee ROM. Study arm 2: Telehealth Group On discharge from hospital, participants who are allocated to the Telehealth Group will receive videoconferencing-based treatment sessions during their first 6 weeks following surgery (twice per week for three weeks, then once per week for the next three weeks). The first session is expected to occur approximately one week following the surgery date (+1 week). Each session will be led by an Accredited Exercise Physiologist (AEP) and consist of 30-minute face-to-face exercise rehabilitation session, with a focus on reviewing their home exercise program (HEP), and measuring their knee ROM. Participants from both groups will receive a standardised HEP consisting of exercise focusing on ROM exercises at the knee and strengthening exercises for the quadriceps, hamstring, calves and gluteals. Participant’s standardised HEPs will be facilitated using the Physitrack app. Physitrack involves video-based demonstrations of exercise technique and dosage, and allows the therapist to monitor daily adherence and patient-reported pain. Patients can contact their health care provider through a messaging system built into the app. The AEP will have a clinic version of Physitrack installed on a device that enables them to review and adjust exercises and communicate with all patients under their care. Participants will receive one notification per day via the Physitrack app reminding them to perform their HEP. At the conclusion of each exercise they will be prompted by the app to record pain (VAS 0-10) and difficulty levels (RPE 0-10) experienced during the exercise. Once recorded, this information becomes available to the AEP. The AEP will review the Physitrack review participant’s progress, assess exercise adherence, adjust exercises as required, and respond to any communications via the messaging system. Patients who have not accessed the app and recorded exercises in Physitrack will be contacted via telephone to discuss their progress. The exercise program has been developed specifically for this research project and has been adapted from exercise programs used in the literature (Bade & Stevens-Lapsley, 2011; Room, Batting, & Barker, 2020). Example of exercises in the HEP include ‘static quadriceps activation’, active-assisted knee flexion’ and ‘seated passive knee extension’. The duration of the home exercise program is expected to be approximately 40 minutes daily - this will vary depending on the progress of the participant. The AEP will monitor and adjust the HEP as required. Participants from both groups will have outcome measures collected in an in-person assessment: pre-surgery, post-surgery (+1 week), 7 weeks post-surgery (+7 weeks), and at 12 months post-surgery (+12 months). Online questionnaires only will be sent at 6 months post-surgery (+6 months). At the +7 weeks session, if it is deemed the participant requires further rehabilitation, they will be booked for an in-person rehabilitation session. The requirement of further exercise will be based on the outcome measures collected by the blinded assessor. Participants will be instructed not to advise the assessor which group they were allocated to or ask clinical questions of the assessor. Likewise, the assessors will not seek this information from the participant. Bade, M. J., & Stevens-Lapsley, J. E. (2011). Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. The Journal of orthopaedic and sports physical therapy, 41(12), 932-941. doi:10.2519/jospt.2011.3734 Room, J., Batting, M., & Barker, K. L. (2020). Development of a functional rehabilitation intervention for post knee arthroplasty patients: community-based Rehabilitation post Knee Arthroplasty (CORKA) trial. Physiotherapy, 106, 52-64. doi:https://doi.org/10.1016/j.physio.2019.06.004

Sponsors

University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients meeting the following criteria were eligible for inclusion in this study: Undergoing primary elective TKR. Agree to attend all weekly rehabilitation sessions (where possible). Agree to attend all in-person assessment time points (where possible). Can independently provide consent.

Exclusion criteria

Patients with the following exclusion criteria will not be eligible if they: Have any comorbidities preventing participation in rehabilitation (e.g. severe obstructive pulmonary disease, hemiplegia following stroke) Are undergoing revision TKR Experience intraoperative complications that prevent participation in rehabilitation Are likely to have problems with follow-up (i.e. patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate support network). Do not read and speak English. Are unable or unwilling to follow the designated post-operative rehabilitation protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026