Innovative Tele-monitored Home-Based Program for Post Total Knee Replacement Rehabilitation: A Noninferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Difference in Fast-paced gait speed
研究概览
简要总结
Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence. A tele-monitored home-based exercise program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.
The primary aim of this non-inferiority randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of an innovative tele-monitored rehabilitation program versus that of currently standard, hospital-based outpatient rehabilitation program among patients post TKR.
详细描述
Study Hypotheses
Primary hypothesis: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to an 10-week hospital-based rehabilitation at 3 and at 6 months after total knee replacement (TKR) in improving physical function (fast gait speed).
Secondary hypothesis 1: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to a 10-week hospital-based rehabilitation at 3 and at 6 months after TKR in improving knee pain, physical impairments, and health-related quality of life.
Secondary hypothesis 2: A 10-week tele-monitored home-based exercise program will be more cost-effective than the 10-week hospital-based rehabilitation in total TKR-related costs
Approach and Methods
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
- Single (Outcomes Assessor)
盲法说明
Because of the nature of the intervention, it is not feasible to blind participants or the treating physiotherapists. To reduce bias, the outcome assessor will be blinded to treatment allocation. Participants will also be instructed not to reveal details about their group assignment to the outcome assessor.
入排标准
- 年龄范围
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary unilateral total knee replacement
- •Age >= 45 years
- •Willingness to be randomized to either tele-monitored home exercise program or outpatient rehabilitation program
- •Ability to provide informed consent
排除标准
- •Further lower limb joint replacement surgery anticipated within the next 6 months
- •Rheumatoid arthritis and other systemic arthritis
- •A previous history of stroke and other major neurological conditions
- •An intention to transfer to step-down care facilities post-operatively.
研究组 & 干预措施
Hospital-based rehabilitation program
干预措施: Hospital-based rehabilitation program (Other)
Tele-monitored home exercise program
干预措施: Tele-monitored home exercise program (Device)
结局指标
主要结局
Difference in Fast-paced gait speed
时间窗: Pre-operation; 3 months and 6 months post-surgery
Difference in fast gait speed (over 10 metres) between the two treatment groups.
次要结局
- Quadriceps muscle strength(Pre-operation; 3 months and 6 months post-surgery)
- Knee Pain: Numeric Pain Rating Scale (NPRS)(Pre-operation; 3 months and 6 months post-surgery)
- STarT Back Screening Tool(Pre-operation; 3 months and 6 months post-surgery)
- 30s chair stand test(Pre-operation; 3 months and 6 months post-surgery)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Pre-operation; 3 months and 6 months post-surgery)
- Treatment credibility(3 months post-surgery)
- Treatment satisfaction: scale(3 months post-surgery)
- Knee range-of-motion(Pre-operation; 3 months and 6 months post-surgery)
- EuroQol-5 Dimensions (EQ-5D-5L) descriptive system(Pre-operation; 3 months and 6 months post-surgery)
- Cost(3 months and 6 months post-surgery)
- Örebro Musculoskeletal Pain Screening Questionnaire (short form)(Pre-operation; 3 months and 6 months post-surgery)