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RecruitingNCT07422714Updated Sep 22, 2026

Application of a Wearable Device-Based Intelligent Rehabilitation System in the Rehabilitation of Patients With Frozen Shoulder

An interventional study of Artificial and intelligent combination of shoulder joint function exercise and Traditional rehabilitation training in Range of Motion, Articular, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Range of Motion, Articular

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Keywords

  • Frozen Shoulder
  • Smart rehabilitation
  • functional exercise
03

In context

Bursitis

383 studies on the registry are indexed under Bursitis; 111 are open to participants now.

This study's planned enrollment of 42 is close to the median of 44 across 346 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Combination of traditional rehabilitation and intelligent rehabilitation

    Other: Artificial and intelligent combination of shoulder joint function exercise

  • Experimental
    Traditional rehabilitation group

    Rehabilitation training by a rehabilitation therapist

    Other: Traditional rehabilitation training

  • Experimental
    Smart rehabilitation group

    Other: Intelligent rehabilitation training

Interventions

  • OtherArtificial and intelligent combination of shoulder joint function exercise

    Rehabilitation therapist rehabilitation and intelligent rehabilitation are combined

    Also known as: Experimental group

  • OtherTraditional rehabilitation training

    Shoulder joint function training is performed by a rehabilitation therapist

  • OtherIntelligent rehabilitation training

    Shoulder joint rehabilitation training is carried out according to the intelligent rehabilitation system

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 0、Week 4 and Week 8

Secondary outcomes

  1. 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.

    Time frame: Week 0、Week 4 and Week 8

  2. 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.

    Time frame: Week 0、Week 4 and Week 8

  3. 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.

    Time frame: Week 0 、Week 4 and Week 8

  4. 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.

    Time frame: Week 0 、Week 4 and Week 8

  5. 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?"

    Time frame: Week 0 、Week 4 and Week 8

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07422714
Responsible party
Sponsor
First posted
Feb 20, 2026
Start date
Sep 17, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Zhenlong Liu
Contact
zhenlong_liu@bjmu.edu.cn
13261993917

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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