Clinical Trial Radar

Constant-Murley Shoulder Assessment Score Scale

The Constant-Murley Shoulder Assessment Score Scale consists of four components: activities of daily living (20 points), pain (15 points), muscle strength (25 points), and range of motion (40 points), with a total score of 100 points. A lower score indicates a higher percentage of dysfunction, while a higher score indicates the opposite. The questionnaire demonstrates high accuracy and reliability and is commonly used to assess patients' shoulder joint conditions.

Week 0、Week 4 and Week 8

Visual Analogue Scale

Visual Analogue Scale is a commonly used subjective pain assessment tool. In this study, patients were asked to use the Visual Analogue Scale score at different follow-up time points to subjectively evaluate the average pain intensity in their affected shoulder. The Visual Analogue Scale scoring method involves drawing a 10 cm horizontal line on paper. One end of the line is marked as 0, indicating no pain, while the other end is marked as 10, indicating severe pain. The middle sections represent varying degrees of pain. Patients are instructed to mark a point on the line based on their self-perceived level of pain.

Week 0、Week 4 and Week 8

Shoulder Range of Motion

Testing Instrument: A plastic Baseline® goniometer (Model 12-100, New York, NY, USA) was used. Testing Method: Shoulder flexion and abduction were assessed in a standing posture. Shoulder extension was measured in the prone position with the elbow flexed at 90°. Shoulder internal rotation was measured in the prone position with the shoulder abducted at 90° and the elbow flexed at 90°. Finally, shoulder external rotation was measured in the supine position with the shoulder abducted at 90° and the elbow flexed at 90° to minimize the impact of measurement errors and individual postural differences. All measurements were conducted by trained professionals and performed in accordance with standardized operating procedures. To enhance data accuracy, each ROM parameter was measured three times, and the average value was used for final analysis.

Week 0、Week 4 and Week 8

Shoulder muscle strength

Muscle strength was measured using a highly reliable portable handheld dynamometer (Power-Track II, J Tech Medical Industries, Midvale, UT, USA). To assess maximum anterior flexion strength, the elbow joint was extended in the anatomical position with the forearm pronated at 90°. For measuring shoulder external rotation strength, the device was horizontally positioned while the participant sat in a neutral posture with the elbow flexed at 90°, and the back was fixed against a wall to prevent trunk movement. Participants were instructed to move in the same direction to measure muscle strength during contraction.

Week 0 、Week 4 and Week 8

Shoulder joint MRI

Shoulder MRI was performed using a 3.0T magnetic resonance scanner (Siemens Healthineers). Professional radiologists (blinded to group assignments) conducted the examinations, with routine sequences including axial PD fat-suppressed, oblique coronal T1WI and T2WI fat-suppressed, and oblique sagittal PD fat-suppressed sequences. All patients' arm positions were standardized (thumb pointing upward). Two radiologists with five years of MRI analysis experience (blinded to patient diagnoses and treatment processes) independently analyzed the images and simultaneously measured the thickness of the coracohumeral ligament (CHL) and the axillary recess capsule (CAR). In cases of significant measurement discrepancies, a third radiologist with ten years of experience performed remeasurements and corrections. Changes in structural thickness were calculated by subtracting the baseline thickness at admission from the post-treatment thickness.

Week 0 、Week 4 and Week 8

Exercise completion rate

The exercise completion rate for the group using the smart rehabilitation system was reported by the system itself. It was calculated by dividing the number of daily completed exercises by the number of daily assigned exercise tasks. The monthly exercise completion rate was the average of the daily completion rates over the entire month.For the control group, the patient-reported exercise completion rate for each month was obtained by asking each patient: "On a scale of 0% to 100%, what was your average exercise completion rate last month?"

Week 0 、Week 4 and Week 8