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

NCT ID: NCT04080401

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Arthroplasty, Replacement Physical Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Game-based rehabilitation exercise

Intervention Type DEVICE

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

Conventional Exercise Brochures

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

Group Type ACTIVE_COMPARATOR

Conventional brochures of rehabilitation exercise

Intervention Type OTHER

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

Interventions

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Game-based rehabilitation exercise

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

Intervention Type DEVICE

Conventional brochures of rehabilitation exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ng Teng Fong Healthcare Innovation Programme

UNKNOWN

Sponsor Role collaborator

Nanyang Technological University- UBC Research Centre in Active Living for the Elderly

UNKNOWN

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Facility Contacts

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Kun Man Li

Role: primary

Eng Chuan Neoh

Role: backup

Other Identifiers

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2017/00229

Identifier Type: -

Identifier Source: org_study_id

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