Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Ambulation status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Ambulation status
时间窗: At hospital discharge, at outpatient review (2-3 weeks post-operation), at outpatient discharge or 3 months post-operation
Use of gait aid, assistance during walking in the home or community
Knee extension range of motion
时间窗: Difference 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.
Knee flexion range of motion
时间窗: Difference 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.
Pain Intensity
时间窗: Difference 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.
次要结局
未报告次要终点