A Feasibility Study to Monitor Post Discharge Activity of Patient Recovery After Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The OKS (Oxford Knee Score) at 12 months post surgery
研究概览
简要总结
This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.
详细描述
This main objective of this feasibility study is to begin to quantify the relationship between patient activity levels following knee replacement surgery and outcomes.
Primary Aims The primary objective of this study is to compare step count and activity levels with key outcome measures - including pain scores and painkiller usage - to determine whether more active people have better recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to converse and understand English
- •The participants must be selected for for single full knee replacement surgery at Milton Keynes University Hospital
- •The participant must have access to a computer at home or be willing to plug a synchronization box into their broadband router
- •The participants must have access to a valid email address or be able to create one for the purpose of this study (this may belong to a spouse, partner, friend or relative) or have access to a mobile phone able to receive SMS (text) messages
排除标准
- •Insufficient language skills to understand the study procedures
- •Cognitive impairment
- •Medical conditions (e.g., severe neurological disorder, acute cancer, psychiatric disorder, acute infections) that prevent participation in the study
- •Wheelchair user
- •Significant lower limb arthritic joints
- •Severe mobility limitation due to central or peripheral respiratory dysfunction
- •Severe mobility limitation due to central or peripheral nervous system disorders
- •Severe mobility limitation due to spinal condition
- •Severe mobility limitation due to musculoskeletal disabilities
- •Rheumatoid arthritis due to joint pain in both upper and lower limbs
结局指标
主要结局
The OKS (Oxford Knee Score) at 12 months post surgery
时间窗: 12 months
Routine physiotherapy review appointment 12 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
The Pain score at 6 months post surgery
时间窗: 6 months
Routine physiotherapy review appointment 6 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.
Mean weekly Oxford Knee Score for 6 weeks following surgery.
时间窗: 6 weeks
For the 6 weeks following surgery, at the end of each week patients will be asked to fill in the 12 question Oxford Knee Score (OKS) questionnaire which will result in an integer score from 0-48 for each week. The outcome measure will be the mean OKS over the 6 week post op period.
Mean Daily Pain Score over 6 weeks following surgery
时间窗: 6 weeks
Participants will be asked to record their NRS-11 (Numeric Rating Scale) pain level in the morning, afternoon and evening daily in a paper diary for six weeks after surgery. NRS-11 is an integer scale from 0-10 with 0 representing no pain and 10 representing worst pain possible. The outcome measure will be the mean pain score from the 6 week post op period.
Change in mean weekly step count between pre surgery and 6 weeks post surgery.
时间窗: 7 weeks
Daily activity level of participant as measured by step count automatically on commercial step counter at one minute granularity from up to one week before surgery up to 6 weeks post surgery. Step count data for days which are deemed non compliant (not wearing device long enough) will be ignored. Total average daily step count (for compliant days) each week will be reported. The outcome measure we plan to use will be the mean daily step count from the 6th week post op. The baseline will be the mean step count from the 1 week prior to surgery.
The OKS (Oxford Knee Score) at 6 months post surgery
时间窗: 6 months
Routine physiotherapy review appointment 6 months post surgery. OKS is collected and uploaded to standard hospital outcomes database.
The Pain score at 12 months post surgery
时间窗: 12 months
Routine physiotherapy review appointment 12 months post surgery. Pain score is collected and uploaded to standard hospital outcomes database.
次要结局
未报告次要终点
研究者
Bev Hoddell
Academic Research Coordinator
Milton Keynes University Hospital NHS Foundation Trust