Clinical trial NCT04080401: Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty
Official title: Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement
Physical Therapy
Keywords: Rehabilitation
Gaming
Exercise
Knee Arthroplasty
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Ng Teng Fong Healthcare Innovation Programme
name: Nanyang Technological University- UBC Research Centre in Active Living for the Elderly
First posted: 2019-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity
timeFrame: Difference in pain score between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
measure: Knee flexion range of motion
timeFrame: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
measure: Knee extension range of motion
timeFrame: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
measure: Ambulation status
timeFrame: At hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References: