Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001168943
Ethics application status
Approved
Date submitted
21/07/2020
Date registered
6/11/2020
Date last updated
9/02/2023
Date data sharing statement initially provided
6/11/2020
Date results information initially provided
9/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of clinic-delivered and telehealth-delivered post-operative rehabilitation
and functional assessment following total knee arthroplasty
Scientific title
A comparison of clinic-delivered and telehealth-delivered post-operative rehabilitation programs, assessing range of motion and function outcomes, following total knee arthroplasty,
Secondary ID [1] 301839 0
CRCPSIX000203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total knee arthroplasty 318323 0
Total knee replacement surgery
 318324 0
Condition category
Condition code
Musculoskeletal 316338 316338 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 317311 317311 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 318135 0
Treatment: Other
Intervention code [2] 318136 0
Rehabilitation
Intervention code [3] 318790 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324503 0
Knee flexion range of motion (ROM)
ROM will be measures using a standard, hand-held goniometer during clinic visits and via video capture for the members of the Telehealth group. Participants will begin in a ‘long sitting’ position with the knees fully extended, then will draw the knees up and bring their feet as close as possible to their buttocks.
Timepoint [1] 324503 0
Participants from both groups will have knee ROM (primary outcome) measures collected in an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (primary time point) and at 12 months post-surgery (+12 months).
In addition, knee ROM will be collected by the treating AEP weekly during the 6-week intervention period, by either goniometry for those in the Clinic group, or via PhysioROM for those in the Telehealth group.
Primary outcome [2] 324504 0
Self-reported knee function, pain, and knee related quality of life measured by completing the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. This questionnaire is a composite primary outcome measurement tool.
Timepoint [2] 324504 0
Participants from both groups will complete the KOOS questionnaire (primary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (primary time point), and at 12 months post-surgery (+12 months).
In addition, participants will complete the KOOS questionnaire via online method at 6 months post-surgery (+6 months).
Secondary outcome [1] 384826 0
Self reported health-related quality of life measured by completing the Short Form Health Survey (SF-36) questionnaire.
Timepoint [1] 384826 0
Participants from both groups will complete the SF 36 questionnaire (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery, and at 12 months post-surgery (+12 months).
In addition, participants will complete the SF 36 questionnaire via online method at 6 months post-surgery (+6 months).
Secondary outcome [2] 384827 0
Self-reported change in condition following surgery measured by completing the Global Rating of Change (GRoC) score.
Timepoint [2] 384827 0
Participants from both groups will complete the GRoC score (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months), and at 12 months post-surgery (+12 months).
In addition, participants will complete the GRoC score via online method at 6 months post-surgery (+6 months).
Secondary outcome [3] 384828 0
Self reported patient satisfaction following knee replacement surgery measured by completing the Patient Satisfaction Following Knee Surgery questionnaire.
Timepoint [3] 384828 0
Participants from both groups will complete the Patient Satisfaction questionnaire (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months), and at 12 months post-surgery (+12 months).
In addition, participants will complete the Patient Satisfaction questionnaire via online method at 6 months post-surgery (+6 months).
Secondary outcome [4] 384829 0
Self-reported digital literacy measured by completing the Telehealth Digital Literacy questionnaire adapted from the eHealth Literacy Assessment Toolkit.
Karnoe A, Furstrand D, Christensen KB, Norgaard O, Kayser L. Assessing Competencies Needed to Engage With Digital Health Services: Development of the eHealth Literacy Assessment Toolkit. J Med Internet Res. 2018;20(5):e178.
Timepoint [4] 384829 0
Participants from both groups will complete the Telehealth Digital Literacy questionnaire (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months), and at 12 months post-surgery (+12 months).
In addition, participants will complete the Telehealth Digital Literacy questionnaire via online method at 6 months post-surgery (+6 months).
Secondary outcome [5] 384830 0
Objective measure of the ability to walk quickly over short distances by completing the 40 meter Fast Paced Walk (FPWT) test.
This test consists of a fast-paced walk that is timed over 4 x 10 meters for a total 40 meters.
Timepoint [5] 384830 0
Participants from both groups will complete the FPWT (secondary outcome) test during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months) and at 12 months post-surgery (+12 months).
Secondary outcome [6] 384831 0
Composite objective measure of sit-to-stand ability, lower body strength and dynamic balance by the 30 Second Sit to Stand (STS) test.
Timepoint [6] 384831 0
Participants from both groups will complete the STS test (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months) and at 12 months post-surgery (+12 months).
Secondary outcome [7] 384832 0
Objective measure of higher demand knee function by completing the timed 9-step Stair Climb Test (9-step SCT).
Timepoint [7] 384832 0
Participants from both groups will complete the 9-step SCT (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months) and at 12 months post-surgery (+12 months).
Secondary outcome [8] 384833 0
Composite objective measure of ambulatory activity, strength, agility and dynamic balance by completing the Timed Up and Go (TUG) test.
Timepoint [8] 384833 0
Participants from both groups will complete the TUG test (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months) and at 12 months post-surgery (+12 months).
Secondary outcome [9] 384837 0
Self-reported measure of acute pain by completing the Visual Analogue Scale (VAS) 0-10 point scale question.
Timepoint [9] 384837 0
Participants from both groups will complete the VAS question (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months), and at 12 months post-surgery (+12 months).
In addition, participants will complete the VAS question via online method at 6 months post-surgery (+6 months).
Secondary outcome [10] 387649 0
Self-reported measure of chronic pain by completing the Visual Analogue Scale (VAS) 0-10 point scale question.
Timepoint [10] 387649 0
Participants from both groups will complete the VAS question (secondary outcome) during an in-person assessment at the following time points: pre-surgery (within two weeks of surgery date), at 7 weeks post-surgery (+7 months), and at 12 months post-surgery (+12 months).
In addition, participants will complete the VAS question via online method at 6 months post-surgery (+6 months).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer.
Opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software (i.e. computerised sequence
generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
After a planned interim analysis, based on the primary outcome (knee ROM) at 7 weeks post surgery, the original sample size (150) showed the trial to be overpowered . The interim analysis showed sufficient power with a sample size of 109.
Date of first participant enrolment
Anticipated
Actual
16/09/2020
Date of last participant enrolment
Anticipated
31/03/2022
Actual
31/03/2022
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
109
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306263 0
Government body
Name [1] 306263 0
Cooperative Research Centre Project (CRC-P) grant entitled “Transforming joint surgery rehabilitation with artificial intelligence in telehealth”. Project number CRCPSIX000203
Country [1] 306263 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 306751 0
Commercial sector/Industry
Name [1] 306751 0
HFRC Rehabilitation Clinic
Address [1] 306751 0
117 Stirling Hwy, Nedlands WA 6009
Country [1] 306751 0
Australia
Other collaborator category [1] 281399 0
Commercial sector/Industry
Name [1] 281399 0
Coviu
Address [1] 281399 0
SE 2/77 Hope Street
South Brisbane QLD 4101
Country [1] 281399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306471 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 306471 0
The University of Western Australia
M459, 35 Stirling Highway
Crawley, WA 6009 Australia
Ethics committee country [1] 306471 0
Australia
Date submitted for ethics approval [1] 306471 0
01/06/2020
Approval date [1] 306471 0
27/07/2020
Ethics approval number [1] 306471 0
RA/4/20/6103

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104006 0
Prof Tim Ackland
Address 104006 0
School of Human Sciences, Faculty of Science
The University of Western Australia
35 Stirling Highway
Crawley, Perth
Western Australia 6009
Country 104006 0
Australia
Phone 104006 0
+61 8 6488 2668
Fax 104006 0
Email 104006 0
[email protected]
Contact person for public queries
Name 104007 0
Prof Tim Ackland
Address 104007 0
School of Human Sciences, Faculty of Science
The University of Western Australia
35 Stirling Highway
Crawley, Perth
Western Australia 6009
Country 104007 0
Australia
Phone 104007 0
+61 8 6488 2668
Fax 104007 0
Email 104007 0
[email protected]
Contact person for scientific queries
Name 104008 0
Prof Tim Ackland
Address 104008 0
School of Human Sciences, Faculty of Science
The University of Western Australia
35 Stirling Highway
Crawley, Perth
Western Australia 6009
Country 104008 0
Australia
Phone 104008 0
+61 8 6488 2668
Fax 104008 0
Email 104008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent form does not allow for sharing of individual data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.