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Trial registered on ANZCTR


Registration number
ACTRN12621000535875
Ethics application status
Approved
Date submitted
10/03/2021
Date registered
6/05/2021
Date last updated
4/07/2022
Date data sharing statement initially provided
6/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Is a digital knee brace helpful for patients with osteoarthritis?
Scientific title
Evaluating a digital knee brace and mobile-based CBT application for the treatment of knee pain in adults aged 65 or younger with knee osteoarthritis: a pilot trial.
Secondary ID [1] 303655 0
None
Universal Trial Number (UTN)
U1111-1262-1076
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 321047 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318849 318849 0 0
Physiotherapy
Musculoskeletal 319244 319244 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two groups. An intervention group and a control group.
Intervention group:
The intervention group will participate in an 8-week combined physical exercise and CBT/Psychoeducation program delivered via a mobile app and utilising a digital knee brace to provide live feedback to the user about movement and range of motion. The intervention consists of two parts:
i. Physical Exercise: The participants will engage in three 30 minute exercise sessions per week over the course of 8 weeks as recommended by the American College of Sports Medicine (Wing & Peterson, 2012). Each session will consist of neuromuscular exercises that have been selected by a physiotherapist based on the successful evidence-based Good Life with osteoArthritis: Denmark (GLA:D) programme (Skou & Roos, 2017). The exercises will begin with low intensity and difficulty and will be appropriately progressed every 2 weeks to ensure adequate strength progression. The first 2 weeks will contain less exercise (only about 15-20 minutes made up of 5 basic exercises) and will later progress to about 30 minutes (9 bodyweight exercises). According to the RPE scale the initial exercises would be rated at a level of 2-3, with the later exercises progressing to a score of 4-5. The exercises remain the same for the final 6 weeks, the only difference is the rep range recommendations increasing to help aid in muscle strength progression and increased endurance.
The participants will only progress to the next stage if they have successfully completed the exercises for the existing 2 weeks. If they can not comfortably complete the given rep ranges, they will not be progressed to the higher rep ranges.
The application has a physician web portal which allows us to prescribe exercises and view whether they have been successfully completing the exercises. A pain score is also requested after each set of exercises so that this can be monitored and followed up on if the user is reporting high levels of pain.
The exercises include basic bodyweight exercises that target various leg muscles to reduce pressure on the knee joint but building up the surrounding muscles. These exercises include sit-to-stands, bodyweight squats, glute bridges, lunges, sideways lunges, step ups, leg extensions, etc. The application includes videos on how to perform these exercises correctly and encourages the use of chairs or other supporting platforms to help reduce strain or likelihood of injury especially when first starting.
Participants will be asked to wear the digital knee brace provided by Opum technologies and connect the Bluetooth tracker to their smartphone. Upon attaching the brace the participant will open the digital knee brace application on their smartphone and begin the program for the day. The application will provide the user with the prescribed exercises and track the amount of time they have spent completing the exercises. The application provides live feedback on whether the exercise is being completed correctly based on data received from the digital knee brace.
ii. Cognitive behavioural therapy (CBT): For the first two weeks (3 sessions per week, 6 sessions total) participants will engage in an approximately 5-10-minute CBT / psychoeducation session delivered via the mobile application. The CBT programme content will be adapted using previous studies on CBT for chronic pain or OA (Carpenter et al., 2012; Hosogoshi et al., 2020). Each session will involve reading through some content to inform and educate about osteoarthritis and exercise. Upon completing
the CBT session the participant will move on to performing the exercises.
At the end of each week participants will be sent an email reminding them to continue participating in the study and informing them how many weeks are left in the study. The participant will also be encouraged to reach out if they have any concerns about the study or intervention, or if there is an adverse event or reaction.
After two weeks (6 sessions) of the CBT modules, the users will get regular notifications on their smartphone reminding them to complete the exercises with positive messages based on the previously learnt content.
We can use the web portal to view whether participants have successfully completed the education or not. The application forces the user to complete the education session before moving onto the exercises and automatically shows this education session first when opening the application for that day. To make the metric comparable between the two groups, we will be using a questionnaire at the end of the study which asks self-report questionnaires on adherence.
Intervention code [1] 319958 0
Rehabilitation
Comparator / control treatment
Control group
The control group will undergo a regular home exercise program as per standard care without the use of a digital knee brace or CBT. The participants will engage in three 30 minute exercise sessions per week over the course of 8 weeks as recommended by the American college of sports medicine (Wing & Peterson, 2012). Each session will consist of neuromuscular exercises that have been selected by a physiotherapist based on the successful evidence-based Good Life with osteoArthritis: Denmark (GLA:D) programme (Skou & Roos, 2017). The exercises will begin with low intensity and difficulty and will be appropriately progressed every 2 weeks to ensure adequate strength progression. The exercises will be given to the participants in the form of a paper-based brochure outlining what the exercises are and how to perform them. The exercises and prescription will all be provided in a single brochure, and instructions will state to progress when ready, i.e. when they have successfully completed the existing suggested rep ranges consistently and comfortably.
The exercise program will be exactly the same as the app group. The exercises, rep ranges, and intensity will all be exactly the same, just delivered in paper form instead of app form.
These exercises include sit-to-stands, bodyweight squats, glute bridges, lunges, sideways lunges, step ups, leg extensions, etc. The brochure includes images as visual instructions on how to perform the exercises properly as well as detailed descriptions. The brochures are being self-made and are study-specific so that the printed content matches the application.

At the end of each week participants will be sent an email reminding them to continue participating in the study and informing them how many weeks are left in the study. The participant will also be encouraged to reach out if they have any concerns about the study or intervention, or if there is an adverse event or reaction
Control group
Active

Outcomes
Primary outcome [1] 326795 0
Composite knee function, stiffness, and pain score measured via the self report Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire.
Timepoint [1] 326795 0
Baseline (before intervention), and upon completion (after 8 week intervention).
Primary outcome [2] 326796 0
Composite knee function, stiffness, and pain score measured via the Knee Osteoarthritis Outcome Score (KOOS).
Timepoint [2] 326796 0
Baseline (before intervention), and upon completion (after 8 week intervention).
Primary outcome [3] 327119 0
Knee-related quality of life assessed using the KOOS Quality of Life subscale.
Timepoint [3] 327119 0
Baseline (before intervention), and upon completion (after 8 week intervention).
Secondary outcome [1] 392705 0
Adherence will be measured via a self-report diary for both groups where participants record all days they completed at least 50% of the exercises prescribed for the day throughout the intervention.
Timepoint [1] 392705 0
Reported / analysed as a total adherence score for the full 8 weeks, and also reported at 2-weekly intervals (4 timepoints total: Week 2, Week 4, Week 6, and Week 8) for further detailed analysis.
Secondary outcome [2] 393854 0
Participants opinions on the usefulness of the digital knee brace and application will be measured with the System Usability Scale (SUS).
Timepoint [2] 393854 0
Post intervention (after 8 weeks, timepoint 2).
Secondary outcome [3] 393861 0
Intention to go have knee replacement surgery in the next 12 months measured with a single question self-report questionnaire.
Timepoint [3] 393861 0
Start of study before beginning programme (baseline, timepoint 1) and end of study after 8 week intervention (timepoint 2).
Secondary outcome [4] 395104 0
Function outcome measure in the form of a standard six-minute walk test. This will be used to determine the maximum distance walked within 6-minutes.
Timepoint [4] 395104 0
Baseline (before intervention) and after completion (after 8 week intervention).

Eligibility
Key inclusion criteria
In order to participate patients must:
- Have Osteoarthritis of the knee in one or both knees.
- Be over the age of 18 and under the age of 85.
- Have access to a smartphone
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
You will not be able to participate if you:
- Have a history of significant injury to either leg in the previous 6-months that
required surgery.
- Are unable to read and speak English
- Are unable to commit to an 8-week intervention

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)
Allocation will be performed digitally via central randomisation by computer where the participants details will be added to the system and the system will randomly allocate the participant to a given group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The planned sample size is 40 patients. This is a pilot trial and therefore has a low number of participants.
The primary outcomes are:
i. Change in WOMAC pain, stiffness and physical function score
ii. Change in 6-minute walk test performance
iii. Change in KOOS Quality of Life subscale score
Participant demographics, characteristics and patient-reported outcomes will be summarised with descriptive statistics.
Mean scores and confidence intervals will be calculated for all measures at both timepoints to provide an estimate of changes. Hedge's g will be calculated with confidence intervals to provide an estimate of effect size.
Secondary Outcome:
Engagement metrics will be summarised with descriptive statistics.

Missing data:
a. Missing data will be dealt with using statistical techniques (multiple imputation) if appropriate
b. To be included in the analysis participants must have completed the baseline and follow up assessments. Participants that drop out following the baseline assessment and do not complete follow up assessment will have their data removed from the analysis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Lockdown.
Date of first participant enrolment
Anticipated
17/05/2021
Actual
14/06/2021
Date of last participant enrolment
Anticipated
30/08/2021
Actual
4/08/2021
Date of last data collection
Anticipated
1/11/2021
Actual
26/09/2021
Sample size
Target
40
Accrual to date
Final
29
Recruitment outside Australia
Country [1] 23526 0
New Zealand
State/province [1] 23526 0
Auckland

Funding & Sponsors
Funding source category [1] 308073 0
University
Name [1] 308073 0
The University of Auckland
Country [1] 308073 0
New Zealand
Funding source category [2] 308074 0
Commercial sector/Industry
Name [2] 308074 0
Opum Technologies
Country [2] 308074 0
New Zealand
Primary sponsor type
Individual
Name
Aidan Messenger
Address
The University of Auckland
Department of Psychological Medicine
Faculty of Medical and Health Sciences
85 Park Road
Grafton
Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 308811 0
Commercial sector/Industry
Name [1] 308811 0
Opum Technologies
Address [1] 308811 0
49 Symonds Street, Grafton
Auckland, New Zealand 1010
Country [1] 308811 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308063 0
Southern Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 308063 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 308063 0
New Zealand
Date submitted for ethics approval [1] 308063 0
03/12/2020
Approval date [1] 308063 0
12/02/2021
Ethics approval number [1] 308063 0
NZ/1/C298115

Summary
Brief summary
Osteoarthritis (OA) of the knee is a common chronic condition that is frequently managed with physical therapy, steroidal injections, pain medications, or surgical knee replacements. However, given OA continues to affect people as young as 40, there is a need for efficacious self-management programs that build skills and provide exercises that can be utilised to better manage OA over the course of one’s life. This study seeks to utilise a “digital knee” brace device designed by Opum labs alongside a mobile application with a CBT intervention to provide exercises, live feedback, and education over 8 weeks with the aim of improving physical outcomes such as a 6-minute walk test, WOMAC scores which tests pain, stiffness, and physical function, and reducing the likelihood of undergoing surgical knee replacement in the near future compared to a conventional home exercise program. The digital knee brace device attaches to the leg of a patient and records various movements to provide live feedback to the patient on how to correctly perform the exercises and monitors progression. The target population is people between the ages of 18-65 with radiographic diagnosis of knee OA and a Kellgren-Lawrence grade of 2 of higher. We aim to recruit 40 participants for this pilot study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109394 0
Mr Aidan Messenger
Address 109394 0
The University of Auckland
Faculty of Medical and Health Sciences
85 Park Road, Grafton, Auckland 1023
Country 109394 0
New Zealand
Phone 109394 0
+64 93737522
Fax 109394 0
Email 109394 0
[email protected]
Contact person for public queries
Name 109395 0
Aidan Messenger
Address 109395 0
The University of Auckland
Faculty of Medical and Health Sciences
85 Park Road, Grafton, Auckland 1023
Country 109395 0
New Zealand
Phone 109395 0
+64 93737522
Fax 109395 0
Email 109395 0
[email protected]
Contact person for scientific queries
Name 109396 0
Aidan Messenger
Address 109396 0
The University of Auckland
Faculty of Medical and Health Sciences
85 Park Road, Grafton, Auckland 1023
Country 109396 0
New Zealand
Phone 109396 0
+64 93737522
Fax 109396 0
Email 109396 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
The data is used for a pilot trial in collaboration with the engineering company who has designed the digital knee brace. All data will be held privately.


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.