About this trial
This study included patients who underwent their first shoulder rotator cuff surgery at Peking University Third Hospital, diagnosed with small to medium rotator cuff tears based on MRI results. Participants were randomly divided into an online wearable device training group and an offline traditional rehabilitation group, with 36 individuals in each group. Before testing began, patients were ensured to participate voluntarily and had signed informed consent forms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
First-time rotator cuff injury surgery and received surgical treatment at Peking University Third Hospital;
MRI shows a tear with a maximum diameter <3 cm, confirmed by at least three musculoskeletal rehabilitation radiologists;
Possess a mobile device with internet access (e.g., smartphone or tablet) capable of using mobile applications;
Disqualifiers
Presence of serious cardiovascular or cerebrovascular diseases, or cervical spondylosis with nerve damage;
Presence of cognitive impairment or vision problems;
Stroke, rheumatic disease, neurological disorders, or diseases limiting overall physical function or cardiopulmonary function within the past 2 years;
No prior history of shoulder joint injury, and having undergone other surgeries within the past 6 months;
Trial design
Parallel
Treatments tested in this trial
Wearable device rehabilitation
DevicePatients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.
Offline Traditional Rehabilitation
Other interventionOffline Traditional Rehabilitation
Treatment groups
Trial outcomes
Primary outcomes
Joint range of motion
Use a goniometer to measure the subject's shoulder flexion, extension, adduction, abduction, internal rotation, and external rotation exercises to test the range of motion of the shoulder in each direction, with the unit in degrees (°).
Upper Limb Closed-Chain Stability Test
For the starting position, male subjects perform a standard push-up, while female subjects perform a knee push-up, keeping their back flat. The distance between the hands is 36 inches. One hand remains in support while the other hand swings to touch the supporting hand and then returns to the starting position. Then switch the supporting hand and repeat the movement. One repetition is counted when the swinging hand leaves the ground, touches the supporting hand, and returns to the starting position. Record the number of full-effort hand touches completed by the subject within 15 seconds, and repeat the test 3 times.
FMS Shoulder Mobility Test
The subjects were asked to make fists with both hands, placing their thumbs inside the fists. Then, the subjects were required to position one shoulder in maximum adduction, extension, and internal rotation, while the other shoulder was in maximum abduction, flexion, and external rotation, and both hands needed to be placed on the back in a smooth movement. Throughout the process, both hands remained clenched in fists. The tester measured the distance between the two closest bony prominences of the hands on the back. The test was repeated three times.
Isometric Strength Test
The subjects performed shoulder flexion, extension, adduction, abduction, internal rotation, and external rotation movements, resisting resistance to perform isometric contractions, and their muscle strength was measured.
Secondary outcomes
Constant- Murley score
It mainly assesses the functional status of the shoulder joint, with higher scores indicating better shoulder function. This includes muscle strength (25 points), pain level (15 points), ability to perform daily activities (20 points), and range of motion of the joint (40 points), for a total of 100 points. Lower scores indicate poorer shoulder joint function.
American Shoulder and Elbow Surgeon's Form
The patient assessment section consists of pain (50%) and cumulative daily activities (50%), forming the scoring part. The total score is 100 points, with higher scores indicating better shoulder function. Scoring method: Pain score = (10 - VAS score) × 5; Function score = total score of 10 items × 5 / 3; Total score = Pain score + Function score.
Western Ontario Rotator Cuff Index
Using a patient self-assessment questionnaire, it consists of 21 questions divided into 5 sections: Signs (questions 1-6), Exercise and Leisure Activities (questions 7-10), Work (questions 11-14), Lifestyle (questions 15-18), and Emotions (questions 19-21). Each question is evaluated using a 100mm VAS, with a maximum score of 100, where 0 indicates normal and 100 indicates abnormal. The total score ranges from 0 to 2100, with 0 indicating normal; the higher the score, the worse the shoulder function.
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