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

NCT07412184 | Recruiting

• 1 other identifier: M20250763
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff tear; Wearable device; Remote rehabilitation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Constant- Murley score

  Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative

• American Shoulder and Elbow Surgeon's Form

  Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative

• Western Ontario Rotator Cuff Index

  Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative

Study Arms (2)

Online Wearable Device Training Group

EXPERIMENTAL

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

Offline Traditional Rehabilitation Group

ACTIVE COMPARATOR

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

Interventions

Wearable device rehabilitation DEVICE

Patients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.

Online Wearable Device Training Group

Offline Traditional Rehabilitation OTHER

Offline Traditional Rehabilitation

Offline Traditional Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Shuang Ren, Doctor

  Affiliated with the organization

  STUDY CHAIR

Central Study Contacts

Shuang Ren, Doctor

CONTACT

17610252992; xixishuang123@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 17, 2026
• Study Start: January 23, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)