None listed
Conditions
Brief summary
The aim of this randomised controlled trial is to compare the safety and efficacy of the MAXM Skate Rehabilitation Device and associated digital rehab program to standard rehabilitative care for elective Knee Arthroplasty Patients in a Public Health Setting. Comparisons will be made between several functional, self-reported and performance-based outcomes measures until the completion of their rehab program 3 months post total knee arthroplasty. It is hypothesised that a TKA patient, in a public health care setting, uses MAXM Skate Device and digital rehab program then they will experience equal or greater return of function, clinical performance, and satisfaction in comparison to those receiving standard rehabilitative care.
Interventions
Participants randomised to the MAXM Skate group will be required to undertake the MAXM Skate rehabilitation program. This involves using the skate device and accompanying Smart device App and sensor to complete a 12-week Rehabilitation Exercise Program. These exercises are pre-set and progressed across a 4-phase Program. A patient must download the MAXM Skate App from their app store. They will log in using their Mobile phone as an identifier to access their user account. The Exercise program requires the patient to complete 3 variations of Skate exercise: Flat Skate, Extension Skate and Flexion skate. These exercises are completed in a chair, utilising the device to move through Knee Joint flexion and Extension. The Skate exercises are also complemented with other TKA strength and movement Rehab exercises such as inner range quads, squats, lunges and walking to make it a full end-to-end program. The exercise challenge increases as a participant progresses through the post-operative weeks. The participant will then be required to wear a sensor module on the operative leg when completing an exercise session. Each session is approximately 25 minutes, with two sessions to be completed per day. Accelerometer data representing the angle of the device relative to gravity is sent to the phone and through an algorithm, displayed to the participant as a % of their full knee ROM (135 deg). As patients complete exercises within their app. It collected the reps and set data along with ROM data to monitor exercise adherence and compliance. Pain scores are also entered by the patient at the end of each exercise completed. No Exercise intensity measure are taken.
Sponsors
Study design
Eligibility
Inclusion criteria
1. The patient requires a primary TKA due to non-inflammatory degenerative joint disease (e.g. osteoarthritis and traumatic arthritis) or inflammatory joint disease (e.g. rheumatoid arthritis). 2. The patient must understand the conditions of the study and be willing and able to provide written informed consent. 3. The patient is a skeletally mature man or a nonpregnant woman, aged greater than or equal to 18 years. 4. The patient agrees to comply with the specified preoperative and postoperative study requirements.
Exclusion criteria
1. The patient has an emotional or neurological condition that would pre-empt their ability to participate in the study including mental illness, intellectual disability and drug or alcohol abuse. 2. Any patient who is unable to meet the requirements of the use of the MAXM Skate Rehabilitation Device. 3. The patient is unable to perform home exercise program without supervision or assistance. 4. Any patient who is unable to understand the information and instructions provided and nature of follow up required. 5. A patient without their own smart device compatible with the MAXM Skate application. (available on iOS and Android devices)