Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Device: Wearable device rehabilitation; Other: Offline Traditional Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuang Ren, Doctor; Phone Number: 17610252992; Email: xixishuang123@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Wearable Device Training Group; The online wearable device training group trained independently using wearable sensor devices according to the 'Fugu Medical Mini Program' instructions. Training started from the 5th week post-surgery and continued until the 12th week, totaling 8 weeks, with a minimum of 3 training days per week and 50 minutes each day.	Device: Wearable device rehabilitation; Patients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.
Active Comparator: Offline Traditional Rehabilitation Group; The offline traditional rehabilitation group carries out rehabilitation training under the guidance of therapists. Starting from the 5th week post-surgery and continuing until the 12th week, the training lasts for a total of 8 weeks, with at least 3 sessions per week, each lasting 50 minutes.	Other: Offline Traditional Rehabilitation; Offline Traditional Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (°).	Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
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.	Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
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.	Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
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.	Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
Surface electromyography	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'.	Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
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.	Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
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.	Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Shuang Ren, Doctor, Affiliated with the organization

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Rotator cuff tear; Wearable device; Remote rehabilitation
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: M20250763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No