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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

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.

Interventions

  • Device: Game-based rehabilitation exercise
    • 4 games (exercises) on operated limb, for 3 sessions daily, until outpatient physiotherapy review visit.
  • Other: Conventional brochures of rehabilitation exercise
    • 4 exercises on operated limb, 30 reps each, for 3 sessions daily, until outpatient physiotherapy review visit.

Arms, Groups and Cohorts

  • Experimental: Fun-Knee Mobile Application
    • 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.
  • Active Comparator: Conventional Exercise Brochures
    • Participants will be guided to do their Total Knee Arthroplasty rehabilitation exercises using conventional, paper-based exercise brochures.

Clinical Trial Outcome Measures

Primary Measures

  • Pain Intensity
    • Time Frame: Difference in pain score between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
    • Visual analogue scale (0-10) for participant-reported pain intensity. Maximum score (10) for worst pain, minimum score (0) for no pain.
  • Knee flexion range of motion
    • Time Frame: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
    • Passive range of knee bending motion measured by handheld goniometry (ranging from -15 to 150 degrees), measuring angle formed by between femur and fibula.
  • Knee extension range of motion
    • Time Frame: Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
    • Passive range of knee straightening measured by handheld goniometry (ranging from -30 to 20 degrees), measuring angle formed by between femur and fibula.
  • Ambulation status
    • Time Frame: At hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operation
    • Use of gait aid, assistance during walking in the home or community

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 51 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tan Tock Seng Hospital
  • Collaborator
    • Ng Teng Fong Healthcare Innovation Programme
  • Provider of Information About this Clinical Study
    • Sponsor

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