Remote App-based Rehabilitation After Rotator Cuff Repair
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHanoi Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Demographics: Individuals aged 18 years or older.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Telerehabilitation
Procedure/SurgeryHigh-quality instructional videos on each stage of the personalized exercise program, with AI-assisted observation and correction for post-surgical rotator cuff tendon repair. Daily automated reminders to keep patients informed of their exercise schedule. Interactive digital log to record completed sessions and pain levels. Asynchronous communication with a physical therapist for guidance and program adjustments. The program is designed to enhance treatment adherence and track patient progress in real time throughout the 6-month rehabilitation period.
Conventional home exercise program
Procedure/SurgeryThe control intervention consists of a conventional home-based exercise program. Patients will receive: During the first 6 weeks, patients will be trained directly by a physical therapist. A printed brochure containing static illustrations and written step-by-step instructions for the post-operative rotator cuff rehabilitation protocol. Standard verbal education from a physiotherapist during the directly training session. Having digital mobile reminders one time per week; patients are expected to manage their exercise frequency independently. Communication with the medical team is limited to scheduled follow-up visits at the hospital and when called by mobile. This group serves as the active comparator to evaluate the added value of the digital mobile application intervention.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Constant-Murley score from baseline to 24 weeks post-surgery
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.
Time frame
From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repair2
Change in Quick DASH score from baseline 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.
Time frame
From baseline (pre-operative) to 24 weeks after arthroscopic rotator cuff repairSecondary outcomes
1
Change in active range of motion of the operated shoulder from baseline to 24 weeks
Active range of motion (forward flexion, abduction, external rotation, and internal rotation) measured with a goniometer. Change from pre-operative baseline to 24 weeks will be compared between groups.
Time frame
Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively2
Change in isometric shoulder strength from baseline to 24 weeks
Isometric muscle strength of the operated shoulder (forward flexion, abduction, external rotation, and internal rotation) measured with a handheld dynamometer (kg). The mean of three trials is recorded. Change from baseline to 24 weeks will be compared between groups.
Time frame
Assessed at baseline (pre-operative), 12 weeks, and 24 weeks post-operatively3
Change in pain intensity (VAS) at rest and during activity from baseline to 24 weeks
Pain intensity measured using the Visual Analog Scale (VAS 0-10) at rest and during activity. Change from pre-operative baseline to 24 weeks will be compared between the intervention and control groups.
Time frame
Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively4
Change in Tampa Scale for kinesiophobia (TSK-11) from baseline to 24 weeks
The TSK-11 is a patient-reported questionnaire used to assess fear of movement or injury. It consists of 11 items, each scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total score ranges from 11 to 44. A higher total score indicates a higher degree of kinesiophobia (greater fear of movement).
Time frame
Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively.Sponsors and contacts
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Source ClinicalTrials.gov
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