Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty: A Pilot Study

Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty

Sponsors

Lead sponsor: Tan Tock Seng Hospital

Collaborator: Ng Teng Fong Healthcare Innovation Programme
Nanyang Technological University- UBC Research Centre in Active Living for the Elderly

Source Tan Tock Seng Hospital
Brief Summary

This study aims to evaluate the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA) surgery, when compared to conventional rehabilitation; where patients learn and perform rehabilitative exercises using printed brochures.

Detailed Description

This is a randomized controlled trial investigating the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA).

All patients receiving TKA will be screened for eligibility. Patients who meet inclusion criteria and provide informed consent will be allocated to either intervention or control group using block randomization. A study team member blinded to subject characteristics will allocate subjects to either group.

Subjects in the intervention group will be guided to do their post-TKA rehabilitation exercises using the investigator's game-based system, which includes the wearable sensor device and mobile application games. Subjects in the control group will be guided to do their post-TKA rehabilitation exercises using conventional, paper-based exercise brochures.

From post-operative day 1, all subjects who are medically fit for physiotherapy will receive 2 sessions of physiotherapy, daily; for at least the first 3 post-operative days. The first session consists of individualized physiotherapy that includes bed exercises and ambulation training. In the second session of physiotherapy, subjects will perform their bed exercises using the game-based system or paper-based exercise brochures. Upon discharge, subjects in the intervention group will continue home-based rehabilitation exercises using the game-based system, while those in the control group continue to use the exercise brochures.

Overall Status Recruiting
Start Date June 1, 2018
Completion Date December 2019
Primary Completion Date December 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain Intensity Difference in pain score between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Knee flexion range of motion Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Knee extension range of motion Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
Ambulation status At hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operation
Enrollment 60
Condition
Intervention

Intervention type: Device

Intervention name: Game-based rehabilitation exercise

Description: 4 games (exercises) on operated limb, for 3 sessions daily, until outpatient physiotherapy review visit.

Arm group label: Fun-Knee Mobile Application

Intervention type: Other

Intervention name: Conventional brochures of rehabilitation exercise

Description: 4 exercises on operated limb, 30 reps each, for 3 sessions daily, until outpatient physiotherapy review visit.

Arm group label: Conventional Exercise Brochures

Eligibility

Criteria:

Inclusion Criteria:

- First, elective, unilateral TKA operation completed in Tan Tock Seng Hospital

- At least two days of inpatient stay

- Discharge to own or carer's home

- Adults >50 years old

- Able to understand and follow instructions consistently

Exclusion Criteria:

- Post-operative infections or wound complications

- Cognitive impairment

- Sensitive/ broken, Irritable skin around operative knee

- Previous TKA on same or opposite knee

- Pregnant women

- Pre-existing skin conditions e.g. eczema

- Poor wound status e.g. poor wound closure or condition

Gender: All

Minimum age: 51 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility status contact contact_backup Tan Tock Seng Hospital Kun Man Li 96306203 [email protected]
Location Countries

Singapore

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Fun-Knee Mobile Application

Arm group type: Experimental

Description: Participants will use a mobile application paired to a knee sleeve with embedded inclinometer sensors. The sensor system will compute knee movement, and feed towards game-based rehabilitation exercises for Total Knee Arthroplasty rehabilitation. game-based and supported on mobile device running on Android or Inter-network Operating System platforms. The mobile apps is able to capture the angle and position data from the two inclinometers on smart knee sleeve.

Arm group label: Conventional Exercise Brochures

Arm group type: Active Comparator

Description: Participants will be guided to do their Total Knee Arthroplasty rehabilitation exercises using conventional, paper-based exercise brochures.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov