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临床试验/NCT07767409
NCT07767409招募中不适用

Cost and Outcomes of Hospital-based Physiotherapy Versus mHealth-based Self-directed Rehabilitation in Patients With Knee Osteoarthritis: A Randomized, Controlled, Non-inferiority Trial

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2026年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Gait speed

研究概览

简要总结

Symptomatic osteoarthritis (OA) of the knee affects approximately one-fifth (~300K) of Singaporeans aged 50 years or older, with the disease prevalence increasing with age. Patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. With an ageing population and the high prevalence of obesity, the annual number of TKRs is projected to rise. Thus, innovative care models are urgently needed to improve patient outcomes while managing or reducing the economic burden of this common and costly public health problem.

Unmet Need: Conservative treatment through physiotherapy rehabilitation is a key intervention, but significant access limitations result in unnecessary TKRs. For patients with knee OA, consensus guidelines are unanimous in recommending education, exercise, and weight management (if required) as first-line interventions. Physiotherapy rehabilitation incorporates these three first-line interventions and is a widely advocated and evidence-based component of OA management. Despite this, international evidence suggests that these core interventions are often under-utilized, with only 20-40% of community-dwelling older adults with knee OA receiving them. Locally and worldwide, suboptimal care from rehabilitation non-attendance is prevalent and costly: available research suggests that at least a quarter of TKRs could have been avoided with optimal care. Thus, to reduce the economic burden of OA, there is a need to develop innovative and flexible rehabilitation strategies.

A mobile health (mHealth)-based program is a likely solution to address this unmet need, but local contextualization is needed. Against this background, an mHealth-based OA self-management program may be a feasible solution to deliver guideline-based interventions, with minimal involvement by healthcare professionals. Whilst several app- or web-based OA self-management programs are available, few have undergone rigorous randomized controlled trial (RCT) evaluation, and still fewer provide detailed instructions to enable self-directed exercise (in particular, muscle strengthening exercises) - despite the evidence that exercise is the cornerstone of knee OA management. Furthermore, the reach and adoption of these programs in Singapore is limited as they are designed for English-speaking patients from Western cultures. Hence, whilst there are potential benefits in harnessing technology-enabled programs, these data emphasize the need for local co-design and adaptation to suit the Singapore context and to facilitate adoption.

Thus, the investigators have, through an iterative user-centered design process, developed Managing Osteoarthritis of the Knee using Therapist Technology Optimized Rehabilitation (MOKneeTOR), a blended digital rehabilitation program integrating an initial face-to-face physiotherapy assessment and an mHealth-enabled exercise and self-management program designed to promote first-line interventions (education, exercise, and weight management where indicated) for patients with knee osteoarthritis.

详细描述

Study Hypotheses

Primary hypothesis: The MOKneeTOR program will be non-inferior to hospital-based physiotherapy rehabilitation at 3 and at 6 months in improving physical function (fast gait speed).

Secondary hypothesis: The MOKneeTOR program will be more cost-effective than hospital-based physiotherapy rehabilitation in reducing total OA-related costs.

Approach and Methods

This will be an assessor-blinded, parallel design, non-inferiority randomized controlled trial, with assessments done at baseline, 3 months, and 6 months after randomization. The protocol conforms to the CONSORT guidelines for eHealth interventions and non-inferiority RCTs.

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 research assistant collecting assessment data will be blinded to treatment allocation. Participants will also be instructed not to reveal details about their group assignment to the outcome assessor to maintain blinding.

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

入选标准

  • All patients who meet the knee OA clinical criteria (aged ≥45 years, activity-related knee pain, and ≤30 min knee joint stiffness in the morning) will be included,
  • an owner of a smartphone,
  • an education level of at least 8 years,
  • a willingness to be randomized to either MOKneeTOR program or outpatient rehabilitation program,
  • an ability to complete baseline assessment.

排除标准

  • 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,
  • significant back or other non-knee pain,
  • pregnant women

研究组 & 干预措施

Hospital-based outpatient rehabilitation program

Active Comparator

Participants will attend, over a 12-week period, a minimum of 3 outpatient physiotherapy sessions, with up to 3 additional sessions if patients are deemed to require them.

干预措施: Hospital-based outpatient rehabilitation program (Other)

MOKneeTOR with standard app configuration

Experimental

MOKneeTOR with standard app configuration will combine both self-reported outcomes and performance-based outcomes to provide objective exercise feedback and criterion-based personalized exercise progression recommendations.

干预措施: MOKneeTOR with standard app configuration (Device)

MOKneeTOR with standard app configuration and enhanced personalisation

Experimental

MOKneeTOR with enhanced personalization will receive MOKneeTOR with standard app configuration and an app experience with an education chatbot that adapts tone, reading level, and format (text, infographics, short videos) to participants' preferences and engagement. Minor person-centred features (e.g., treating therapist caricature avatars and name-badged messages) will also be incorporated to strengthen therapeutic alliance without altering clinical guidance.

干预措施: MOKneeTOR with standard app configuration and enhanced personalisation (Device)

结局指标

主要结局

Gait speed

时间窗: baseline, 3 months and 6 months post baseline visit

This provides a performance-based measure of physical function. Participants will walk at their usual pace (warm-up) and fast pace along a 4-metre walkway, with a 2.5-metre acceleration distance before and a 2.5-metre deceleration distance after the timed section. Gait timing will be captured concurrently using both a stopwatch and a time-of-flight sensor. Gait speed (m/s) will be calculated for both walking conditions; however, time-of-flight sensor-based fast-paced gait speed will be the primary outcome measure.

次要结局

  • Knee strength(baseline, 3 months and 6 months post baseline)
  • Lower limb strength and mobility(baseline, 3 months and 6 months post baseline)
  • Treatment satisfaction(3 months post baseline)
  • Treatment recommendation(3 months post baseline)
  • Global perceived effect (GROC)(3 months post baseline)
  • Exercise Compliance(3 months post baseline)
  • Exercise Compliance(3 months and 6 months post baseline)
  • App usability(3 months post baseline)
  • Short Form of the Western Ontario and McMaster Universities Osteoarthritis Index (ShortMAC F)(baseline, 3 months and 6 months post baseline)
  • Knee Pain: Numeric Pain Rating Scale (NPRS)(baseline, 3 months and 6 months post baseline)
  • Health-related quality of life - Euro Qol Group 5-Dimension (EQ-5D-5L)(baseline, 3 months and 6 months post baseline)
  • Cost outcomes: Healthcare utilization costs(3 months and 6 months post baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pua Yong Hao

Senior Principal Physiotherapist

Singapore General Hospital

研究点 (1)

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