Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001698268
Ethics application status
Approved
Date submitted
3/10/2018
Date registered
15/10/2018
Date last updated
15/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a game-based application (SuperGramps) in
rehabilitation for total knee arthroplasty patients in a tertiary hospital in Singapore
Scientific title
Evaluating the effectiveness of a game-based application (SuperGramps) in
rehabilitation for total knee arthroplasty patients in a tertiary hospital in Singapore
Secondary ID [1] 296248 0
None
Universal Trial Number (UTN)
U1111-1221-6222
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee arthroplasty 309908 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308690 308690 0 0
Physiotherapy
Musculoskeletal 308724 308724 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the intervention group, patients will receive the standard physiotherapy intervention by attending physiotherapist and be taught how to play the game on post op day 1. The exercises taught via the game (straight leg raise and heel slides), will not be taught in the traditional manner. Apart from the 2 exercises, all standard physiotherapy interventions will be carried out.

From day 2 onwards, patients will play the supergramps game for knee ranging and muscle strengthening exercises without standard physiotherapy intervention. These patients will continue to be seen once daily by the physiotherapist to be assessed and ambulated with an appropriate walking aid during their inpatient stay. They would be advised to play the game 3x a day.

Patients in the intervention group will be provided with an inertial measurement unit (IMU) which is a triangular device which they are to put on. The device will be taped onto silicon belts, which the participants are required to place around their thigh and calf. The device will be able to communicate with the game on a tablet provided in order to facilitate participation of the patient. The game will require the patient to control the character either by bending their knees or lifting their legs, similar to the exercises done post-total knee arthroplasty surgeries.
Patients will be encouraged to do these exercises 3x/day, as per usual protocol. The game should take about 10-15 minutes to complete.

The participants are required to play the game for 3 days post surgery, after which the inertial measurement units and tablets will be collected back. We will monitor adherence to the game by checking their game results on a separate portal.
Intervention code [1] 312577 0
Rehabilitation
Comparator / control treatment
In the control group, patients will receive the standard physiotherapy
intervention daily as per knee arthroplasty protocol for knee ranging and muscle strengthening exercises during their acute inpatient hospital stay. Exercises taught include heel slides, static quadriceps contraction, inner range quadriceps activation, straight leg raises. They will be seen once a day by the physiotherapist and encouraged to do the exercises twice in their own time.

The usual orthopaedic team members will be carrying out the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 307660 0
Knee range, as measured by a goniometer by a blinded assessor
Timepoint [1] 307660 0
End of day 1, 2, and 3 post surgery
Primary outcome [2] 307703 0
Ability to perform straight leg raise as assessed by a blinded assessor, with a goniometer to measure knee angle during straight leg raise
Timepoint [2] 307703 0
End of day 1, 2, and 3 post surgery
Primary outcome [3] 307704 0
Patient satisfaction after using the game (for intervention group) using a 4 question questionairre
Timepoint [3] 307704 0
Once at the end of day 3 post surgery
Secondary outcome [1] 352509 0
Pain score at rest - using a verbal numerical scale or simple pain description scale.
Timepoint [1] 352509 0
Post operative day 1, 2 and 3
Secondary outcome [2] 352587 0
Level of assistance and gait aid required during therapy sessions post surgery. This assessment will be based on clinical judgement by the treating physiotherapist and documented in the patients charts.

This information will be pulled from patients medical records.
Timepoint [2] 352587 0
Post operative day 1, 2, 3

Eligibility
Key inclusion criteria
The inclusion criteria for research participants are:
1. Age between 50-85 years
2. Had undergone primary unilateral TKA for knee osteoarthritis
3. Premorbid ambulant
4. Able to follow game instructions
5. Able to use an electronic device (e.g. iPad) other than making a phone call
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for research participants are:
1. Had revision TKA
2. Had a history of lower limb fracture
3. Had a history of stroke or other neurological disorders (e.g. Parkinson's disease, dementia)
4. Had developed intra- or post-operative medical or surgical complications
5. Required knee brace post-operation
6. Had visual or auditory impairment
7. Colour blind
8. Sensitive to silicone
9. With Multidrug-Resistant Organisms (MDRO)

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)
Allocation was done by study team member who is not involved in recruitment of subjects/participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation done by computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2018
Actual
Date of last participant enrolment
Anticipated
4/03/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 20896 0
Singapore
State/province [1] 20896 0
singapore

Funding & Sponsors
Funding source category [1] 300845 0
Hospital
Name [1] 300845 0
Singapore General Hospital
Country [1] 300845 0
Singapore
Primary sponsor type
Individual
Name
Samantha Koh
Address
Singapore General Hospital
Department of Physiotherapy
Outram Rd, Singapore 169608
Country
Singapore
Secondary sponsor category [1] 300393 0
None
Name [1] 300393 0
-
Address [1] 300393 0
-
Country [1] 300393 0
Other collaborator category [1] 280378 0
Individual
Name [1] 280378 0
Eleanor Chew
Address [1] 280378 0
Singapore General Hospital
Department of Physiotherapy
Outram Rd, Singapore 169608
Country [1] 280378 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301613 0
Centralised Institutional Review Board - SingHealth Research
Ethics committee address [1] 301613 0
Ethics committee country [1] 301613 0
Singapore
Date submitted for ethics approval [1] 301613 0
21/02/2018
Approval date [1] 301613 0
27/02/2018
Ethics approval number [1] 301613 0
2017/2965

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

Contacts
Principal investigator
Name 87558 0
Ms Samantha Koh
Address 87558 0
Singapore General Hospital
Department of Physiotherapy
Outram Rd, Singapore 169608
Country 87558 0
Singapore
Phone 87558 0
+65 81821542
Fax 87558 0
Email 87558 0
[email protected]
Contact person for public queries
Name 87559 0
Samantha Koh
Address 87559 0
Singapore General Hospital
Department of Physiotherapy
Outram Rd, Singapore 169608
Country 87559 0
Singapore
Phone 87559 0
+65 81821542
Fax 87559 0
Email 87559 0
[email protected]
Contact person for scientific queries
Name 87560 0
Samantha Koh
Address 87560 0
Singapore General Hospital
Department of Physiotherapy
Outram Rd, Singapore 169608
Country 87560 0
Singapore
Phone 87560 0
+65 81821542
Fax 87560 0
Email 87560 0
[email protected]

No information has been provided regarding IPD availability


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.