Rotator Cuff TearNCT07412184
Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury
A study testing Wearable device rehabilitation and Offline Traditional Rehabilitation in people with Rotator Cuff Tear, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Wearable device rehabilitation and Offline Traditional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Wearable device rehabilitation, Offline Traditional Rehabilitation
- Keywords
- Rotator cuff tear, Wearable device, Remote rehabilitation
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable device rehabilitationDevice
Patients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'.
Offline Traditional RehabilitationOther
Offline Traditional Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Offline Traditional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (°).
Measured: 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.
Measured: 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.
Measured: 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.
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'.
Measured: Preoperative, 1 month postoperative, 3 months postoperative, 6 months postoperative.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start23 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuang Ren, Doctor, Study chair, Affiliated with the organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412184
- Sponsor's protocol ID
- M20250763
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury
- ClinicalTrials.gov ID
- NCT07412184
- Acronym / sponsor ID
- M20250763
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator cuff tear, Wearable device, Remote rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Wearable Device Training Group | Experimental | Device: Wearable device rehabilitationThe 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. |
| Offline Traditional Rehabilitation Group | Active comparator | Other: Offline Traditional RehabilitationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable device rehabilitationPatients with rotator cuff tears wear sensors and undergo training in conjunction with 'Fugu Medical'. | Device | Online Wearable Device Training Group |
| Offline Traditional RehabilitationOffline Traditional Rehabilitation | Other | Offline Traditional Rehabilitation Group |
Primary outcome
Joint range of motion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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'.
3 secondary outcomes
Constant- Murley score
Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
American Shoulder and Elbow Surgeon's Form
Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
Western Ontario Rotator Cuff Index
Time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuang Ren, Doctor study chair
Affiliated with the organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable device rehabilitation and Offline Traditional Rehabilitation in people with Rotator Cuff Tear, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuang Ren, Doctor (17610252992, xixishuang123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint range of motion (time frame: Preoperative baseline, 1 month postoperative, 3 months postoperative, 6 months postoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.