Effectiveness of a Combined Intervention Incorporating a Remote Rehabilitation Application for Patients After Arthroscopic Repair of Rotator Cuff Tears: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Constant-Murley score from baseline to 24 weeks post-surgery
研究概览
简要总结
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.
详细描述
Shoulder pain is the third most common medical condition seen in primary care settings, with 65-70% of patients experiencing rotator cuff injuries. Therefore, rotator cuff injuries significantly impact patients' mobility and place a considerable burden on the healthcare system and employers. The majority of patients are treated conservatively; however, approximately 40% of patients with rotator cuff tears, in which the primary injury is a tear of the supraspinatus and infraspinatus tendons, experience persistent pain and require surgical intervention. Effective rehabilitation programs can address disability and functional impairments in patients, such as joint range of motion, muscle strength, and persistent pain.
However, not all patients who have undergone rotator cuff surgery have full access to in-person rehabilitation programs due to geographical, financial, and awareness barriers, or other objective factors such as epidemics. Furthermore, many patients lack the skills and knowledge to perform guided exercises at home, or receive inadequate guidance. In this context, tele-rehabilitation is considered a potential solution to mitigate the drawbacks of in-person and self-training methods.
This study was designed to address gaps in practical implementation by evaluating whether the addition of a culturally adapted smartphone-based telerehabilitation application to standard postoperative physiotherapy could improve clinical outcomes compared to using standard physiotherapy alone.
The primary objective was to determine the effectiveness of combined telerehabilitation intervention on shoulder function, as measured by changes in Constant-Murley and Quick DASH scores 24 weeks after arthroscopic repair of rotator cuff tendon injuries.
Secondary objectives include assessing the impact of the intervention on active range of motion, isotonic shoulder strength, pain intensity, specific functional capacity of the patient, psychological factors (movement anxiety and rehabilitation confidence), treatment adherence, health-related quality of life, return to work status, direct non-medical costs, and caregiver time burden. The study will also assess safety through the rate of rotator cuff re-tear after 24 weeks and investigate factors related to treatment response. The study employs a comprehensive biopsychosocial assessment. Beyond physical recovery, we evaluate the interplay between psychological barriers (kinesiophobia via TSK-11), psychological assets (self-efficacy via SER), and resulting clinical behavior (adherence via EARS) to provide a holistic view of the patient's rehabilitation journey.
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 assessors responsible for evaluating clinical endpoints, such as the Constant-Murley score, Quick DASH score and range of motion, muscle strength, are blinded to the treatment group assignment of the participants to ensure objectivity.
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
- •Demographics: Individuals aged 18 years or older.
- •Diagnosis: Confirmed symptomatic rotator cuff tear requiring surgical intervention, specifically involving:
- •Clinical Presentation: Persistent shoulder pain and functional deficits (e.g., positive impingement signs or weakness in abduction/external rotation) consistent with rotator cuff pathology.
- •Radiological Confirmation: Imaging evidence (MRI or high-resolution ultrasound) of a full-thickness supraspinatus and/or infraspinatus tendon tear.
- •Tear Characteristics: Small-to-medium-sized tears (maximum diameter < 5 cm) categorized as reparable by the attending surgeon.
- •Surgical Procedure: Patients undergoing primary arthroscopic rotator cuff repair (ARCR) utilizing a standardized double-row suture bridge technique.
- •Rehabilitation Adherence: Commitment to follow the standardized postoperative rehabilitation protocol as prescribed by the study.
- •Cognitive and Functional Capacity:
- •Absence of cognitive impairment, with the ability to comprehend and execute complex exercise instructions.
- •Proficiency in digital literacy, including the regular use of an internet-enabled electronic device (smartphone, tablet, or computer) capable of video-based communication and data transmission.
- •Documentation and Consent:
- •Availability of comprehensive medical records, including pre- and postoperative clinical and radiological data.
- •Provision of written informed consent by the patient or a legal representative prior to enrollment
排除标准
- •Pre-existing or concomitant upper extremity dysfunction unrelated to the rotator cuff tear, including cervical disc herniation, cerebrovascular accident (stroke), traumatic brain injury, cervical spinal cord injury, rheumatoid arthritis with shoulder involvement, or brachial plexus injury.
- •Complex or irreparable rotator cuff tears, defined as large or massive tears (> 5 cm), high-grade fatty infiltration of the rotator cuff muscles (Goutallier grade ≥ 3), or inability to achieve secure tendon repair using sutures during arthroscopic surgery.
- •Postoperative complications that significantly interfere with rehabilitation, such as surgical site infection, nerve injury with paralysis, or severe deltoid muscle damage.
- •Severe comorbidities that may substantially affect the rehabilitation process or patient safety, including acute coronary syndrome, recent stroke, uncontrolled diabetes mellitus, or other debilitating systemic diseases.
- •Inability or unwillingness to comply with the study protocol, including failure to attend scheduled follow-up assessments or voluntary withdrawal from the study.
研究组 & 干预措施
Experimental Group
Patients in this group will perform a structured home-based rehabilitation program guided by a mobile application (RehaX, RealPT). The app provides instructional videos for exercises, daily reminders, and a digital diary to track progress. Additionally, patients can communicate with physiotherapists through a built-in messaging system for guidance and adjustments to their exercise protocol. For the first six weeks, patients receive direct instruction from a physiotherapists. After six weeks, patients receive instruction guided by the mobile application.
干预措施: Telerehabilitation (Procedure)
Control Group
Patients in this group will follow a standard home rehabilitation program. They will receive a printed booklet with still images and written instructions on the same exercise regimen as the experimental group. For the first six weeks, patients will receive direct instruction from a rehabilitation technician. After six weeks, patients will exercise independently at home. No digital monitoring devices or mobile applications will be provided; patients will monitor their health status with therapists during regular clinic visits.
干预措施: Conventional home exercise program (Procedure)
结局指标
主要结局
Change in Constant-Murley score from baseline to 24 weeks post-surgery
时间窗: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
The Constant-Murley Shoulder Score is a validated shoulder-specific outcome measure that evaluates pain, activities of daily living, range of motion, and strength (total score 0-100, higher scores indicate better function). The primary outcome is the mean change in Constant-Murley score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
Change in Quick DASH score from baseline to 24 weeks after arthroscopic rotator cuff repair
时间窗: From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair
The Quick DASH (Quick Disabilities of the Arm, Shoulder and Hand) is a patient-reported questionnaire assessing upper extremity physical function and symptoms (score 0-100, lower scores indicate better function). The primary outcome is the mean change in Quick DASH score from pre-operative baseline to 24 weeks after arthroscopic rotator cuff repair. These co-primary outcomes will be compared between the tele-rehabilitation intervention group and the standard physical therapy control group.
次要结局
- Change in active range of motion of the operated shoulder from baseline to 24 weeks(Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively)
- Change in isometric shoulder strength from baseline to 24 weeks(Assessed at baseline (pre-operative), 12 weeks, and 24 weeks post-operatively)
- Change in pain intensity (VAS) at rest and during activity from baseline to 24 weeks(Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively)
- Change in Tampa Scale for kinesiophobia (TSK-11) from baseline to 24 weeks(Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively.)
- Rotator cuff re-tear rate at 24 weeks post-operatively(At 24 weeks after arthroscopic rotator cuff repair)
- Time and level of return to work at 24 weeks(Assessed at 12 weeks and 24 weeks post-operatively)
- Caregiver Productivity Loss at 24 weeks(24 weeks (accumulated from baseline))
- Change in Health-related quality of life (EQ-5D-5L) at 24 weeks(Assessed at 24 weeks post-operatively)
- Change in Self-Efficacy for Rehabilitation Scale (SER) at 24 weeks(Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively)
- Change from baseline in Exercise Adherence Rating Scale (EARS) at 24 weeks.(6 weeks, 12 weeks, 24 weeks post-operatively)
- Total Direct Non-Medical Costs at 24 weeks.(24 weeks (accumulated from baseline))
研究者
Pham Dinh Phuong
Principal Investigator
Hanoi Medical University