None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
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