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

T

Tan Tock Seng Hospital

Status

Unknown

Conditions

Arthroplasty, Replacement
Physical Therapy

Treatments

Device: Game-based rehabilitation exercise
Other: Conventional brochures of rehabilitation exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04080401
2017/00229

Details and patient eligibility

About

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 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.

Enrollment

60 estimated patients

Sex

All

Ages

51+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Fun-Knee Mobile Application
Experimental group
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.
Treatment:
Device: Game-based rehabilitation exercise
Conventional Exercise Brochures
Active Comparator group
Description:
Participants will be guided to do their Total Knee Arthroplasty rehabilitation exercises using conventional, paper-based exercise brochures.
Treatment:
Other: Conventional brochures of rehabilitation exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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