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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04080401
Enrollment
60
Registered
2019-09-06
Start date
2018-06-01
Completion date
2019-12-31
Last updated
2019-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Physical Therapy

Keywords

Rehabilitation, Gaming, Exercise, Knee Arthroplasty

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.

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.

Interventions

DEVICEGame-based rehabilitation exercise

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

OTHERConventional brochures of rehabilitation exercise

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain IntensityDifference 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.
Knee flexion range of motionDifference 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.
Knee extension range of motionDifference 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.
Ambulation statusAt hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operationUse of gait aid, assistance during walking in the home or community

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026