Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001092583p
Ethics application status
Submitted, not yet approved
Date submitted
26/03/2024
Date registered
10/09/2024
Date last updated
10/09/2024
Date data sharing statement initially provided
10/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Study on the use MAXM Skate Digital Rehab Solution in the Public Health setting following Total Knee Arthroplasty
Scientific title
A Randomised Controlled Study on the use MAXM Skate Digital Rehab Solution in the Public Health setting following Total Knee Arthroplasty
Secondary ID [1] 311801 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
 333317 0
Total Knee Replacement 333318 0
Rehabilitation 333319 0
Total Knee Arthroplasty 333320 0
Post operative Mental Health 334986 0
Condition category
Condition code
Musculoskeletal 330003 330003 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 330004 330004 0 0
Physiotherapy
Physical Medicine / Rehabilitation 330005 330005 0 0
Other physical medicine / rehabilitation
Surgery 330006 330006 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328248 0
Rehabilitation
Intervention code [2] 329397 0
Treatment: Devices
Comparator / control treatment
Participants randomised to the Standard Care group will receive the standard care provided as per Southern Adelaide Local Health Network (SALHN) Arthroplasty Hip and Knee Protocol.
Control group
Active

Outcomes
Primary outcome [1] 337763 0
Knee Joint Range of Motion
Timepoint [1] 337763 0
Baseline, 2 , 6 and 12 weeks (primary End Point) post-operatively
Secondary outcome [1] 433201 0
Pain upon knee flexion
Timepoint [1] 433201 0
Baseline, 2 , 6 and 12 weeks post operatively
Secondary outcome [2] 433202 0
Physical Function
Timepoint [2] 433202 0
Baseline, 2 , 6 and 12 weeks post operatively
Secondary outcome [3] 433203 0
Quality of Life
Timepoint [3] 433203 0
Baseline, 2 , 6 and 12 weeks post operatively
Secondary outcome [4] 433204 0
Physical Function
Timepoint [4] 433204 0
Baseline, 2 , 6 and 12 weeks post operatively
Secondary outcome [5] 439234 0
Pain upon Knee Extension
Timepoint [5] 439234 0
Baseline, 2 Weeks, 6 Weeks and 12 Weeks Post - operatively
Secondary outcome [6] 439235 0
Anxiety and Depression- this will be assessed as a composite outcome
Timepoint [6] 439235 0
Baseline, 2 Weeks, 6 Weeks and 12 Weeks Post-operatively
Secondary outcome [7] 439236 0
Pain
Timepoint [7] 439236 0
Baseline, 2 weeks, 6 Weeks and 12 Weeks Post-operatively

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by excel spreadsheet
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Power Calculation:

A sample size calculation based on achieving 90% power and a Type 1 error rate of 5% was chosen. The calculation determined that 110 participants (55 participants per group) would be required to detect a 10° difference in ROM between the MAXM program and SC groups three months after TKA assuming a within-group standard deviation (SD) of 16°. The clinically significant difference in ROM of 10° was estimated based on parameters described by Mockford colleagues (Mockford et al., 2008) in which the effect of a physiotherapy regimen on ROM was measured over a one-year post-TKA follow-up period. To account for a potential 10% loss to follow-up, a total sample of 124 participants (62 per group) is to be recruited.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
20/03/2026
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26307 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 42279 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 316137 0
Commercial sector/Industry
Name [1] 316137 0
MAXM Skate Pty LTD
Country [1] 316137 0
Australia
Funding source category [2] 316141 0
Government body
Name [2] 316141 0
Department of State Development - Seed Start Grant
Country [2] 316141 0
Australia
Funding source category [3] 317294 0
Hospital
Name [3] 317294 0
Noarlunga Hospital
Country [3] 317294 0
Australia
Funding source category [4] 317295 0
Commercial sector/Industry
Name [4] 317295 0
MAXM Skate Pty Ltd
Country [4] 317295 0
Australia
Funding source category [5] 317296 0
University
Name [5] 317296 0
Flinders University
Country [5] 317296 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 318312 0
Commercial sector/Industry
Name [1] 318312 0
MAXM Skate Pty Ltd
Address [1] 318312 0
Country [1] 318312 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314962 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 314962 0
Ethics committee country [1] 314962 0
Australia
Date submitted for ethics approval [1] 314962 0
15/03/2024
Approval date [1] 314962 0
Ethics approval number [1] 314962 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133266 0
A/Prof Christopher Wilson
Address 133266 0
Noarlunga Hospital - 30 Alexander Kelly Dr, Noarlunga Centre SA 5168
Country 133266 0
Australia
Phone 133266 0
+61416564557
Fax 133266 0
Email 133266 0
[email protected]
Contact person for public queries
Name 133267 0
Luka Millar
Address 133267 0
MAXM Skate - 27 Oaklands Rd, Somerton Park SA 5044
Country 133267 0
Australia
Phone 133267 0
+61407786951
Fax 133267 0
Email 133267 0
[email protected]
Contact person for scientific queries
Name 133268 0
Luka Millar
Address 133268 0
MAXM Skate - 27 Oaklands Rd, Somerton Park SA 5044
Country 133268 0
Australia
Phone 133268 0
+61407786951
Fax 133268 0
Email 133268 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
Sensitive commercial Data


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.