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Trial registered on ANZCTR

Registration number

ACTRN12616001589471

Ethics application status

Approved

Date submitted

10/11/2016

Date registered

17/11/2016

Date last updated

11/03/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Pilot (Feasibility) Study of Personalised Internet-based Rehabilitation Program Incorporating Electronic Functional Monitoring after Total Knee Arthroplasty

Scientific title

Pilot (Feasibility) Study of Personalised Internet-based Rehabilitation Program Incorporating Electronic Functional Monitoring after Total Knee Arthroplasty

Secondary ID [1]

TRI-01

Universal Trial Number (UTN)

U1111-1189-6983

Trial acronym

PRP study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

total knee arthroscopy recovery

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Personalised Rehabilitation Program (PRP) device consists of two non-invasive hardware devices secured or strapped above and below the knee, each consisting of an accelerometer, an SD card and a microcontroller. The devices are fitted approximately 1-4 weeks before surgery (minimum of 4 days), depending on a convenient time for the patient and the investigator to meet prior to the surgery date.

The devices are then worn continuously for 6 weeks after the surgery if the investigator deems that period to be sufficient for the rehabilitation period (e.g., there is a plateau in the outcomes being assessed), or for a further 6 weeks, which is a total of 12 weeks post surgery, if the investigator deems the patient is still rehabilitating at the 6 week post surgery visit.

These devices connect wirelessly to a dedicated Smart-device (e.g. tablet) application using Bluetooth. The application gathers and logs data before transferring the data to cloud-based storage and a software platform for review by the patient and their clinician.

The software presents both summary information as well as recommended “next best decision” to guide the patient’s medication, physiotherapy and psychological rehabilitation. The device is intended to supplied as a reusable, over-the-counter therapy aide for patients recovering from joint replacement surgeries of the knee.

The means of securing the devices to the skin may be a strap or a medically compliant adhesive (“Rocktape”) with an in-built metal pin that will allow the sensor casing to be securely attached by a magnet. This method will be easy for patients with poor eyesight and arthritic hands to use. As this securing pad is made of medically compliant material, then the only risk is a very low incidence of allergic response.

Patients consenting to total knee arthroplasty will be given a full explanation of the study.
Written consent will be required for treatment with the “Personalised Rehabilitation Program” (PRP).
Subjects will be given a tablet computer that will receive messages from their hardware devices and asks the subject questions. A program in this device will help guide the subject's preparation for surgery and their recovery after surgery. The subject will be shown how to use the tablet computer until they are comfortable with it.

The recordings of the functional parameters are de-identified and sent to a web-based ‘cloud’ file storage in Australia and then to the application via a Smart device and the data is shown on the user interface. The app on the Smart device will use the data to display updated points on the subject’s charts. These data will also trigger automatic responses from the app. If the data falls outside pre-determined limits then a message will be sent to the specialist and the nominated team (e.g. secretary, practice nurse) alerting them to this. Alternatively, if sufficient functional upgrading has been made then the option of increasing their activity will be offered automatically 2 days after the previous increase. In addition “gamification strategies” in the form of rewards (e.g. comments such as “Well done - you have reached your goal”) will be used to reward improvements in function and encourage further gains.

In addition subjects will complete some on-line questionnaires about how they are feeling and managing and also about their ability to do acts of daily living. There will be daily questions to answer on the tablet such as:

“Do you feel confident to continue with the program tomorrow?”
"How much does your pain bother you today?" (on an 11 point scale)
"How happy are you with your progress?"

Participants will complete a set of validated questionnaires using the Smart device at the scheduled in-clinic visits, and at home. Clinic visits are scheduled at baseline (4 days to 4 weeks prior to knee surgery), V1 (day prior to surgery), V2 (2 weeks post surgery), V3 (6 weeks post surgery - can be final if patient is rehabilitated) and V4 (12 weeks post surgery if required).

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome is success, in terms of patient satisfaction with the protocol, as assessed by a daily question:
Are you satisfied with the program? The response is YES or NO.

Timepoint [1]

Daily from the baseline visit (device fitting) through to device removal (6 weeks or 12 weeks)

Secondary outcome [1]

Measurement of changes in psychosocial and functional outcome data with treatment protocol.

Assessment used to explore the program's usefulness:

Oxford Knee Score (OKS)

Timepoint [1]