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

NCT04080401 | Unknown DMC

• 1 other identifier: 2017/00229
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement; Physical Therapy

Keywords

Rehabilitation; Gaming; Exercise; Knee Arthroplasty

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  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

  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

  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

  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

Study Arms (2)

Fun-Knee Mobile Application

EXPERIMENTAL

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

Conventional Exercise Brochures

ACTIVE COMPARATOR

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

Other: Conventional brochures of rehabilitation exercise

Interventions

Game-based rehabilitation exercise DEVICE

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

Fun-Knee Mobile Application

Conventional brochures of rehabilitation exercise OTHER

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

Conventional Exercise Brochures

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Ng Teng Fong Healthcare Innovation Programme: collaborator
• Nanyang Technological University- UBC Research Centre in Active Living for the Elderly: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: September 6, 2019
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)