Rotator Cuff Tear
Conditions
Keywords
Rotator cuff tear, Wearable device, Remote rehabilitation
Brief summary
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.
Detailed description
In this randomized controlled clinical study, patients with unilateral rotator cuff tears were included. Starting from the fifth week after surgery, they were randomly assigned to either an online wearable device training group or an offline traditional rehabilitation group, with analyses conducted through functional tests and assessments. The study investigated the impact of wearable device rehabilitation on functional recovery in patients with rotator cuff tears and compared it with offline traditional rehabilitation to verify its efficacy.
Interventions
DEVICEWearable device rehabilitation
Patients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.
OTHEROffline Traditional Rehabilitation
Offline Traditional Rehabilitation
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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; * Able to complete the planned study and follow-ups within 6 months after discharge; * No visual, hearing, cognitive, or communication impairments; * Able to provide informed and valid consent to participate in the study.
Exclusion criteria
* 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; * Patients who cannot complete the entire cycle or drop out midway; * Presence of serious postoperative complications, such as wound infection, venous thromboembolism, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Joint range of motion | Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative | 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 | Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative | 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 | Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative | 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 | Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative | 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. |
| Surface electromyography | Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative. | Using the Delsys surface electromyography (EMG) test device to measure the surface EMG signals of shoulder muscles such as the anterior, middle, and posterior deltoid, serratus anterior, upper, middle, and lower trapezius, and supraspinatus during maximal voluntary contraction tests, with the unit of measurement being '%BW'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant- Murley score | Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative | 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 | Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative | 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 | Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative | 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. |
Countries
China
Contacts
CONTACTShuang Ren, Doctor
STUDY_CHAIRShuang Ren, Doctor
Affiliated with the organization
Outcome results
None listed