RecruitingACTRN12616001081404

A Randomised Controlled Study on the Maxm Skate: A Lower Limb Rehabilitation Device for use following Total Knee Arthroplasty.

Sponsor

Professor Jeganath Krishnan

Enrollment

116 participants

Start Date

Oct 18, 2018

Study Type

Interventional

Conditions

Degenerative Joint Disease Total Knee Arthroplasty

Summary

The Maxm Skate is a portable lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting. It allows the patient to perform strengthening exercises with minimal joint loading during their rehabilitation period. The primary objective of this randomised controlled study is to assess the range of motion (ROM) achieved by patients whom received the Maxm Skate rehabilitation device compared with standard rehabilitative care, 3 months post total knee replacement. The secondary objectives of the study will be to compare functional, clinical performance and quality of life outcomes following use of the Maxm Skate compared with standard rehabilitative care. An economic evaluation assessing the relative cost-effectiveness of the Maxm Skate rehabilitation device compared to standard care will be also be conducted. Adverse event occurrences and complications will be screened from the time of consent to 1 year postoperatively. We aim to recruit a study sample size of 116 participants, with 58 per group. The primary endpoint is range of movement (ROM) which will be analysed on an intention to treat basis, using linear regression.

Eligibility

Sex: Both males and femalesMin Age: 30 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people who are having a total knee replacement. It tests a portable rehabilitation device called the Maxm Skate — a gliding board that lets you do knee strengthening exercises at home with less stress on the joint — to see if it helps people regain range of motion and recover better than standard physiotherapy alone. You may be eligible if: - You are 30 years of age or older - You are having a first-time total knee replacement for osteoarthritis, traumatic arthritis, or rheumatoid arthritis - You are able to do a home exercise program on your own without constant supervision - You are willing and able to give informed consent You may NOT be eligible if: - You have an emotional or neurological condition (such as mental illness, intellectual disability, or drug/alcohol problems) that would prevent you from participating - You cannot safely perform home exercises without supervision or assistance Talk to your doctor about whether this trial might be right for you.

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Interventions

The Maxm skate is a portable, lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting. The Maxm Skate package is comprised o

The Maxm skate is a portable, lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting. The Maxm Skate package is comprised of the Skate device and rope (for resistance training), sensors, iOS Application (App) and website. The Skate device is accompanied by two sensors and a mobile App which are designed to provide real time, objective data on exercise and rehabilitation progress, in particular ROM achieved, following an exercise therapy session at home. This sensor technology also enables the clinician to gather accurate compliance and ROM data (Flexion and Extension) remotely. Participants will attend a pre-operative device education session where they will be introduced to the Maxm Skate by the physiotherapist. Participants will be given a description of the functionality, set up and safe usage of the Maxm Skate and will be given the opportunity to trial the skate. Participants will be educated on the Maxm Skate exercise program and issued an exercise booklet to familiarize themselves with the post-operative exercise program. The Maxm Skate exercise program can be found on the following website: http://www.maxmskate.com.au/ The Maxm Skate rehabilitation device is intended to be used up to 3 months post-surgery, however can be used for a longer duration if felt of benefit. In the inpatient acute setting the Maxm Skate group will receive the Maxm Skate in addition to standard care. Compliance with the Maxm Skate rehabilitation program will be measured using the Compliance with Rehabilitation Program Form, which collects data on number and duration of Maxm skate sessions, as well as whether additional physiotherapy has been sought.