A Randomised Comparison of Clinic- Versus Telehealth-delivered Early-stage Post-operative Rehabilitation and Functional Assessment Following Total Knee Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Knee-Related Quality of Life (QOL) subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
The goal of this clinical trial is to determine if rehabilitation delivered by telehealth works as well as rehabilitation delivered in person at a clinic, for people recovering from total knee replacement surgery. The main question it aims to answer is:
• Does rehabilitation by video call lead to knee-related quality of life that is just as good as rehabilitation completed in person at a clinic?
Researchers will compare a telehealth group to a clinic group to see if telehealth rehabilitation works as well as in-person rehabilitation.
Participants will:
- Take part in 9 rehabilitation sessions over 6 weeks, either by video call from home or in person at a clinic
- Follow a home exercise program using an online app
- Answer questions about their knee and daily activities before surgery, and again at 7 weeks, 6 months, and 12 months after surgery
- Have their knee movement and physical abilities, such as walking speed and climbing stairs, measured by a therapist before surgery, and again at 7 weeks, and 12 months after surgery
详细描述
This randomised controlled, single-blinded, non-inferiority trial compared telehealth-delivered versus clinic-based (in-person) early-stage rehabilitation following primary total knee arthroplasty (TKA).
Following written informed consent and pre-operative baseline assessment, participants were randomised to either a Telerehabilitation or Clinic group using a computer-generated sequence, with allocation concealed by an independent researcher. The primary outcome assessor remained blinded to group allocation throughout the study.
Both groups received an identical rehabilitation protocol comprising nine supervised sessions delivered over a 6-week post-operative period (twice weekly for the first three weeks, followed by once weekly for a further three weeks), commencing 4-7 days after surgery. Each session lasted approximately 30 minutes and was delivered by Accredited Exercise Physiologists. Sessions addressed pain and swelling management, safe and progressive ambulation, activities of daily living, review and progression of a structured Home Exercise Program (HEP), and monitoring of knee range of motion.
The Clinic group attended sessions in person at a single private rehabilitation clinic. The Telerehabilitation group received the same sessions remotely via a telehealth platform (Coviu, Sydney, Australia). Both groups were provided the HEP through an online exercise-delivery platform (Physitrack, Physitrack Ltd., London, UK), which included video-based exercise demonstrations, adherence monitoring, and secure patient-provider messaging. HEP frequency and intensity were progressively modified over the 6-week program according to individual pain tolerance, knee range of motion progression, and treating therapist judgement.
Outcome assessments were conducted pre-operatively and at 7 weeks (following completion of the rehabilitation intervention), and at 6 and 12 months post-surgery. All in-person clinical assessments were conducted by a single therapist who remained blinded to group allocation.
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
- Double (Investigator, Outcomes Assessor)
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
- •undergoing primary elective TKA for the treatment of end stage knee OA
- •ability to independently provide informed consent
- •a willingness to attend all rehabilitation sessions and assessment time points, irrespective of the delivery
排除标准
- •comorbidities preventing participation in rehabilitation (e.g., severe obstructive pulmonary disease, hemiplegia)
- •revision TKA
- •intra-operative complications precluding rehabilitation
- •likely difficulties with follow-up
- •inability to read or speak English
- •unable to attend in person clinic visits due to travel distance
- •unwillingness to comply with the rehabilitation protocol
研究组 & 干预措施
Clinic Group
Treatment sessions were delivered in-person at a single private rehabilitation clinic.
干预措施: Rehabilitation treatment sessions focussing on education and exercise prescription. (Behavioral)
Telerehabilitation Group
Treatment sessions were delivered and supervised remotely using telerehabilitation technology.
干预措施: Rehabilitation treatment sessions focussing on education and exercise prescription. (Behavioral)
结局指标
主要结局
Knee-Related Quality of Life (QOL) subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery
KOOS-QOL is a 4-item subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that assesses knee-related quality of life. Scores range from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates no knee-related problems. Higher scores indicate better knee-related quality of life.
次要结局
- Active knee flexion range of movement (ROM)(Pre-operative, 7 weeks post-surgery, and 12 months post-surgery)
- 9-Step Stair Climb Test (SCT)(Pre-operative, 7 weeks post-surgery, and 12 months post-surgery)
- Pain subscale (KOOS-PAIN) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- Symptom subscale (KOOS-SYMPTOM) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- Activity of Daily Living (KOOS-ADLs) subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- Sport and Recreation subscale (KOOS-Sport and Recreation) of the Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- Active knee extension range of movement (ROM)(Pre-operative, 7 weeks post-surgery, and 12 months post-surgery)
- Visual Analogue Scale for Pain Severity (VAS-S)(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- University of California, Los Angeles (UCLA) activity scale(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- Timed Up and Go (TUG) Test(Pre-operative, 7 weeks post-surgery, and 12 months post-surgery)
- 30-Second Sit-to-Stand (STS) Test(Pre-operative, 7 weeks post-surgery, and 12 months post-surgery)
- 40m Fast-Paced Walk Test (FPWt)(Pre-operative, 7 weeks post-surgery, and 12 months post-surgery)
- Global Rating of Change (GRC)(7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- Self-Administered Patient Satisfaction Scale (SAPS)(7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- 36-Item Short Form Health Survey (SF-36)(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
- e-Health Literacy Assessment Toolkit (eHLA)(Pre-operative, 7 weeks post-surgery, 6 months post-surgery, and 12 months post-surgery)
研究者
Ray Seaby
Principle Investigator
The University of Western Australia