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

Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04080401
• Other study ID #: 2017/00229
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement
• Physical Therapy

Intervention

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.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Nanyang Technological University- UBC Research Centre in Active Living for the Elderly, Ng Teng Fong Healthcare Innovation Programme

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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