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

September 8, 2019 updated by: Tan Tock Seng Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Game-based rehabilitation exercise
4 games (exercises) on operated limb, for 3 sessions daily, until outpatient physiotherapy review visit.
Active Comparator: Conventional Exercise Brochures
Participants will be guided to do their Total Knee Arthroplasty rehabilitation exercises using conventional, paper-based exercise brochures.
Other: Conventional brochures of rehabilitation exercise
4 exercises on operated limb, 30 reps each, for 3 sessions daily, until outpatient physiotherapy review visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Difference in pain score between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
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.
Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
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.
Difference in angle between hospital discharge and first outpatient physiotherapy review (within 3 weeks post-operation)
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
At hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 8, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017/00229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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