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临床试验/NCT07773480
NCT07773480尚未招募不适用

Formative Evaluation of a Mobile Application Facilitated Self-Directed Rehabilitation Programme for the Conservative Management of Knee Osteoarthritis

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Feasibility

研究概览

简要总结

In Singapore, knee osteoarthritis (OA) is a prevalent musculoskeletal condition, reflecting global trends of an aging population and lifestyle factors. With Singapore's rapidly aging population and the rising prevalence of obesity and sedentary lifestyles, knee OA has become increasingly common. According to recent studies, symptomatic OA of the knee affects around one-fifth (~300K) of Singaporeans aged 50 years or older. Individuals with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. While knee replacement surgery is an effective option for severe knee OA, it is costly and there are risks of complications, and should only be considered when all appropriate non-surgical treatment options have been exhausted. Existing research suggests at least a quarter of knee replacements could have been avoided through more optimal conservative treatments.

Despite established healthcare systems and treatment pathways, studies in several settings report that the majority of patients with OA do not receive appropriate and optimal medical care. In Singapore, several factors such as cost, extended wait times, cultural factors and travel inconvenience pose barriers to accessing physiotherapy services. These factors hinder patients' ability to access care resulting in suboptimal care, poor outcomes, and needless economic burden. Thus, there is a large unmet need for innovative and flexible strategies to deliver effective conservative management and treatment for knee OA widely and at a relatively low cost.

Solutions that empower individuals and allow for self-directed rehabilitation without the need for real-time human supervision could be the key to improve effectiveness, accessibility and reduce the reliance on healthcare manpower. Given the prevalence of mobile phone, mobile applications offer a promising avenue for delivering self-directed rehabilitation programs to adults with knee OA. Previous self-directed rehabilitation programs for patients with knee OA have shown promise, however, the adoption and adherence to these programmes remain low, particularly among older adults who may not be technologically savvy. Developing an application that is tailored to the needs and capabilities of older adults with knee osteoarthritis is crucial to improve engagement and long-term adherence to the programme.

The investigators have previously developed a technology-enabled self-directed rehabilitation program for patients who have undergone TKR for primary knee OA. Subsequently, Managing Osteoarthritis of the knee using Therapist-Technology Optimized Rehabilitation (MO-knee-TOR) - a standalone mobile app to facilitate self-directed rehabilitation and complement a "blended" care approach involving an initial face-to-face session with the physiotherapist was developed. MO-knee-TOR was developed for patients with TKR and subsequently evaluated in 2 pilot randomised controlled trials (RCTs). In one of the RCTs, it was found that self-directed rehabilitation post TKR facilitated using the mobile application improved exercise adherence without compromising safety and clinical outcomes. In this current proposal, MO-knee-TOR is adapted for conservative knee OA management through a single-arm pre-post feasibility study with a nested qualitative component.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the National Institute for Health and Care Excellence (NICE) osteoarthritis clinical criteria (7)
  • aged 45 years and over
  • activity related knee joint pain
  • morning stiffness ≤30 min
  • History of knee pain on most days for ≥3 months
  • Able to give informed consent and to participate fully in the interventions and assessment procedures
  • Has a smartphone and be willing to use it during the study.
  • Able to share photos/ videos with other phone contacts using smartphone

排除标准

  • Patients who meet any of the exclusion criteria mentioned below will be excluded from participation.
  • Rheumatoid arthritis and other systemic arthritis
  • A previous history of stroke and other major neurological conditions
  • An intention to undergo knee joint replacement surgery or have had a knee joint replacement
  • Has significant back or other non-knee pain

研究组 & 干预措施

Self-directed rehabilitation using the mobile application

Experimental

Participants will be instructed on the installation and use of the mobile application on their personal mobile phones. Participants will then have to perform the assigned tasks using the mobile application for 12 weeks

干预措施: Self-directed rehabiliation using the mobile application (Device)

结局指标

主要结局

Feasibility

时间窗: 12 weeks after using the mobile application

The feasibility of evaluating the prototype in a larger trial will be assessed using predefined progression criteria including, including recruitment and retention rates, adherence to the program, incidence of adverse events, and improvement in function. Progression will be guided using thresholds categorized as "proceed," "proceed with protocol amendments," or "significant amendments required" based on the criteria defined for each feasibility domain.

次要结局

  • Gait speed(Pre-intervention; 12 weeks after using the mobile application)
  • Knee range-of-motion(Pre-intervention; 12 weeks after using the mobile application)
  • Incidental and planned exercise (IPEQ)(12 weeks after using the mobile application)
  • Health-related quality of life(Pre-intervention; 12 weeks after using the mobile application)
  • Muscle strength(Pre-intervention; 12 weeks after using the mobile application)
  • Handgrip strength test(Pre-intervention; 12 weeks after using the mobile application)
  • Weight bearing symmetry(Pre-intervention; 12 weeks after using the mobile application)
  • 5-repetition-sit-to-stand test(Pre-intervention; 12 weeks after using the mobile application)
  • Physical function(Pre-intervention; 12 weeks after using the mobile application)
  • Treatment satisfaction(12 weeks after using the mobile application)
  • Exercise Compliance/Adherence(12 weeks after using the mobile application)
  • Brief Fear of Movement(Pre-intervention; 12 weeks after using the mobile application)
  • Psychological distress(Pre-intervention; 12 weeks after using the mobile application)
  • Perceived Need for Knee Replacement Surgery(Pre-intervention; 12 weeks after using the mobile application)
  • Pain(Pre-intervention; 12 weeks after using the mobile application)
  • Participant Experience and Perceptions (Exit Interview)(12 weeks after using the mobile application)
  • Physical Function(Pre-intervention; 12 weeks after using the mobile application)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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