The Effect of Hybrid Tele-rehabilitation Versus Standard Rehabilitation in Patients With Knee Osteoarthritis: A Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the pain intensity measured by Numeric pain rating scale
研究概览
简要总结
People with knee osteoarthritis often need regular physiotherapy sessions to reduce pain and improve movement. Attendance of in-person sessions can be difficult because of travel and time. This study aims to learn if combining in-person and video sessions using Zoom works for people with knee osteoarthritis. The main questions it aims to answer are :
- Does combining in-person and video sessions improve pain and physical function in people with knee osteoarthritis?
- Does combining in-person and video sessions improve adherence to the exercise program?
- Are people satisfied with video sessions using Zoom?
The researchers will compare the use of one in-person session and one video session per week to the standard care of two in-person sessions per week.
Participants will :
- Attend either (one in-person and one video session per week) or (two in-person sessions per week) for 8 weeks.
- Perform exercise program that suits their needs during in-person and video sessions.
- Record the number of attended sessions over 8 weeks.
- Complete questionnaires about pain, physical function at the start and the end of the study.
- Complete questionnaire about usability and satisfaction at the end of the study.
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
The outcome assessor will be blinded to the group allocation
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate knee osteoarthritis.
- •Age 40 to 80 years old.
- •Body Mass Index < 34 kg/m
- •Numeric pain rating scale > 4 out of
- •Pain for more than 3 months.
- •Morning stiffness lasting < 30 minutes (standard clinical criteria of knee osteoarthritis)
- •Pain and crepitus with active motion (e.g., walking, sit to stand, stair climbing) (standard clinical criteria of knee osteoarthritis)
- •Access to the device with an internet connection.
- •Ability to use electronic devices or smart phones.
排除标准
- •Severe knee osteoarthritis and limited mobility or bonded to a wheelchair.
- •Body Mass Index > 34 kg/m2
- •On a waiting list for hip or knee surgery.
- •Undergoing other forms of rehabilitation.
- •Previous knee arthroplasty.
- •Recent knee surgery within 6 months.
- •Received cortisone injection within the previous 30 days.
- •Rheumatoid arthritis, bilateral knee morning stiffness > 30 minutes.
- •Unstable medical conditions.
研究组 & 干预措施
Hybrid Tele-rehabilitation
participants will receive one in-person and one video session per week for 8 weeks. Both sessions include the same exercise program delivered by a physiotherapist.
干预措施: Hybrid Tele-rehabilitation (Other)
Standard Rehabilitation
participants will receive two in-person sessions per week for 8 weeks. All sessions include an exercise program delivered by a physiotherapist.
干预措施: Standard Rehabilitation (Other)
结局指标
主要结局
Change in the pain intensity measured by Numeric pain rating scale
时间窗: Baseline and after 8 weeks of the intervention
The Numeric pain rating scale assesses the pain intensity using 11 points scale, where 0 indicates no pain and 10 indicates the worst pain
Change in physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Baseline and after 8 weeks of the intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a validated self reported questionnaire designed to assess the physical function of individuals with knee osteoarthritis. it consists of 17 items rated on a 5-points Likert scale ( 0=none, 4=extreme). Scores range from 0 to 68, in which higher scores indicate worse physical function
Changes in lower limb strength measured by 30 seconds chair stand test
时间窗: Baseline and after 8 weeks of the intervention
The 30 seconds chair stand test assesses the lower limb strength and functional performance. The participant will be asked to stand straight and return to sitting on a standard high chair as many times as possible within 30 seconds without using their arms. The total number of completed full stand will be recorded and a higher number indicates better lower limb strength and function.
次要结局
- Exercise adherence measured by weekly adherence log(Weekly during 8 weeks of the intervention and at the end of the 8 weeks)
- Usability and satisfaction of Zoom based tele-rehabilitation measured by Tele-health Usability Questionnaire.(After 8 weeks of the intervention)
研究者
Anfal Adnan Astek
Principle investigator
King Abdulaziz University