Range of Motion, ArticularNCT07422714
Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder
A study testing Artificial and intelligent combination of shoulder joint function exercise, Traditional rehabilitation training and Intelligent rehabilitation training in people with Range of Motion, Articular, run by Peking University Third Hospital at 1 site in China.
Trial summary
A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Range of Motion, Articular
- What is being tested?
- Artificial and intelligent combination of shoulder joint function exercise, Traditional rehabilitation training and Intelligent rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2026to 30 Jun 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria:① Subjects are aged between 40 and 60 years (inclusive), regardless of gender;
- Diagnosed with the adhesive phase of frozen shoulder by the Department of Sports Medicine, with patients potentially coming from different physicians;
- Have not participated in any other clinical trials within the past 3 months; ④ Patients voluntarily agree to participate in the clinical trial, sign the informed consent form, and are able to cooperate with clinical follow-up.
Exclusion Criteria:① Patients with combined cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, coagulation disorders, severe electrocardiogram abnormalities, etc.;
- Patients with local lesions in the affected shoulder or arm, such as skin damage, infection, tuberculosis, tumors, or skin diseases;
- Patients with poor physical condition who are unable to tolerate the intensity of rehabilitation training; ④ Patients with cognitive impairments who cannot undergo normal rehabilitation training, or other conditions deemed by the physician as unsuitable for trial participation; ⑤ Pregnant or breastfeeding women; ⑥ Patients with other shoulder conditions, such as rotator cuff tears or shoulder dislocation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Zhenlong Liu, 13261993917, zhenlong_liu@bjmu.edu.cn
About this study
A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation
Read the detailed description
Frozen Shoulder (FS), as a diffuse inflammatory disease, involves the glenohumeral joint, joint capsule, synovial tissues, and glenohumeral ligaments. Current management of FS includes conservative and surgical treatments. However, there remains room for improvement in the efficacy of conservative rehabilitation for FS. This study intends to enroll subjects diagnosed with Frozen Shoulder (FS) and conduct a randomized controlled trial to compare the safety and effectiveness of traditional rehabilitation versus remote intelligent rehabilitation for FS. Evaluations will include patient pain scores, shoulder joint function, and magnetic resonance imaging findings to observe the therapeutic effects of different interventions. This study aims to address how to enhance the rationality of FS patient management and identify the optimal rehabilitation treatment plan, thereby assisting FS patients in restoring daily living and motor functions as soon as possible.
- Conditions
- Range of Motion, Articular
- Being tested
- Artificial and intelligent combination of shoulder joint function exercise, Traditional rehabilitation training, Intelligent rehabilitation training
- Keywords
- Frozen Shoulder, Smart rehabilitation, functional exercise
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial and intelligent combination of shoulder joint function exerciseOther
Also called Experimental group
Rehabilitation therapist rehabilitation and intelligent rehabilitation are combined
Traditional rehabilitation trainingOther
Shoulder joint function training is performed by a rehabilitation therapist
Intelligent rehabilitation trainingOther
Shoulder joint rehabilitation training is carried out according to the intelligent rehabilitation system
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Combination of traditional rehabilitation and intelligent rehabilitation Receives: Other: Artificial and intelligent combination of shoulder joint function exercise |
| Traditional rehabilitation group | Experimental | Rehabilitation training by a rehabilitation therapist Receives: Other: Traditional rehabilitation training |
| Smart rehabilitation group | Experimental | Not described Receives: Other: Intelligent rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Shoulder Assessment Score Scale
The Constant-Murley Shoulder Assessment Score Scale consists of four components: activities of daily living (20 points), pain (15 points), muscle strength (25 points), and range of motion (40 points), with a total score of 100 points. A lower score indicates a higher percentage of dysfunction, while a higher score indicates the opposite. The questionnaire demonstrates high accuracy and reliability and is commonly used to assess patients' shoulder joint conditions.
Measured: Week 0、Week 4 and Week 8
Secondary outcomes (5)
Visual Analogue Scale
Visual Analogue Scale is a commonly used subjective pain assessment tool. In this study, patients were asked to use the Visual Analogue Scale score at different follow-up time points to subjectively evaluate the average pain intensity in their affected shoulder. The Visual Analogue Scale scoring method involves drawing a 10 cm horizontal line on paper. One end of the line is marked as 0, indicating no pain, while the other end is marked as 10, indicating severe pain. The middle sections represent varying degrees of pain. Patients are instructed to mark a point on the line based on their self-perceived level of pain.
Measured: Week 0、Week 4 and Week 8
Shoulder Range of Motion
Testing Instrument: A plastic Baseline® goniometer (Model 12-100, New York, NY, USA) was used.
Testing Method:
Shoulder flexion and abduction were assessed in a standing posture. Shoulder extension was measured in the prone position with the elbow flexed at 90°. Shoulder internal rotation was measured in the prone position with the shoulder abducted at 90° and the elbow flexed at 90°. Finally, shoulder external rotation was measured in the supine position with the shoulder abducted at 90° and the elbow flexed at 90° to minimize the impact of measurement errors and individual postural differences.
All measurements were conducted by trained professionals and performed in accordance with standardized operating procedures. To enhance data accuracy, each ROM parameter was measured three times, and the average value was used for final analysis.
Measured: Week 0、Week 4 and Week 8
Shoulder muscle strength
Muscle strength was measured using a highly reliable portable handheld dynamometer (Power-Track II, J Tech Medical Industries, Midvale, UT, USA). To assess maximum anterior flexion strength, the elbow joint was extended in the anatomical position with the forearm pronated at 90°. For measuring shoulder external rotation strength, the device was horizontally positioned while the participant sat in a neutral posture with the elbow flexed at 90°, and the back was fixed against a wall to prevent trunk movement. Participants were instructed to move in the same direction to measure muscle strength during contraction.
Measured: Week 0 、Week 4 and Week 8
Shoulder joint MRI
Shoulder MRI was performed using a 3.0T magnetic resonance scanner (Siemens Healthineers). Professional radiologists (blinded to group assignments) conducted the examinations, with routine sequences including axial PD fat-suppressed, oblique coronal T1WI and T2WI fat-suppressed, and oblique sagittal PD fat-suppressed sequences. All patients' arm positions were standardized (thumb pointing upward). Two radiologists with five years of MRI analysis experience (blinded to patient diagnoses and treatment processes) independently analyzed the images and simultaneously measured the thickness of the coracohumeral ligament (CHL) and the axillary recess capsule (CAR). In cases of significant measurement discrepancies, a third radiologist with ten years of experience performed remeasurements and corrections. Changes in structural thickness were calculated by subtracting the baseline thickness at admission from the post-treatment thickness.
Measured: Week 0 、Week 4 and Week 8
Exercise completion rate
The exercise completion rate for the group using the smart rehabilitation system was reported by the system itself. It was calculated by dividing the number of daily completed exercises by the number of daily assigned exercise tasks. The monthly exercise completion rate was the average of the daily completion rates over the entire month.For the control group, the patient-reported exercise completion rate for each month was obtained by asking each patient: "On a scale of 0% to 100%, what was your average exercise completion rate last month?"
Measured: Week 0 、Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start17 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Range of Motion, ArticularStudies 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
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422714
- Sponsor's protocol ID
- M20251134
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 22 Sep 2026
- Results posted
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT07422714
- Acronym / sponsor ID
- M20251134
- Conditions
- Range of Motion, Articular
- Keywords
- Frozen Shoulder, Smart rehabilitation, functional exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 17 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 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.
A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation
Detailed description
Frozen Shoulder (FS), as a diffuse inflammatory disease, involves the glenohumeral joint, joint capsule, synovial tissues, and glenohumeral ligaments. Current management of FS includes conservative and surgical treatments. However, there remains room for improvement in the efficacy of conservative rehabilitation for FS. This study intends to enroll subjects diagnosed with Frozen Shoulder (FS) and conduct a randomized controlled trial to compare the safety and effectiveness of traditional rehabilitation versus remote intelligent rehabilitation for FS. Evaluations will include patient pain scores, shoulder joint function, and magnetic resonance imaging findings to observe the therapeutic effects of different interventions. This study aims to address how to enhance the rationality of FS patient management and identify the optimal rehabilitation treatment plan, thereby assisting FS patients in restoring daily living and motor functions as soon as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Artificial and intelligent combination of shoulder joint function exerciseCombination of traditional rehabilitation and intelligent rehabilitation |
| Traditional rehabilitation group | Experimental | Other: Traditional rehabilitation trainingRehabilitation training by a rehabilitation therapist |
| Smart rehabilitation group | Experimental | Other: Intelligent rehabilitation training |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Artificial and intelligent combination of shoulder joint function exerciseAlso: Experimental groupRehabilitation therapist rehabilitation and intelligent rehabilitation are combined | Other | Experimental group |
| Traditional rehabilitation trainingShoulder joint function training is performed by a rehabilitation therapist | Other | Traditional rehabilitation group |
| Intelligent rehabilitation trainingShoulder joint rehabilitation training is carried out according to the intelligent rehabilitation system | Other | Smart rehabilitation group |
Primary outcome
Constant-Murley Shoulder Assessment Score Scale
Time frame: Week 0、Week 4 and Week 8
The Constant-Murley Shoulder Assessment Score Scale consists of four components: activities of daily living (20 points), pain (15 points), muscle strength (25 points), and range of motion (40 points), with a total score of 100 points. A lower score indicates a higher percentage of dysfunction, while a higher score indicates the opposite. The questionnaire demonstrates high accuracy and reliability and is commonly used to assess patients' shoulder joint conditions.
5 secondary outcomes
Visual Analogue Scale
Time frame: Week 0、Week 4 and Week 8
Shoulder Range of Motion
Time frame: Week 0、Week 4 and Week 8
Shoulder muscle strength
Time frame: Week 0 、Week 4 and Week 8
Shoulder joint MRI
Time frame: Week 0 、Week 4 and Week 8
Exercise completion rate
Time frame: Week 0 、Week 4 and Week 8
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 22 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial and intelligent combination of shoulder joint function exercise, Traditional rehabilitation training and Intelligent rehabilitation training in people with Range of Motion, Articular, 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?
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 22 Sep 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 Zhenlong Liu (13261993917, zhenlong_liu@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Shoulder Assessment Score Scale (time frame: Week 0、Week 4 and Week 8). 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 22 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.