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

A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation

Study Overview

• Status: Recruiting
• Conditions: Range of Motion, Articular
• Intervention / Treatment: Other: Artificial and intelligent combination of shoulder joint function exercise; Other: Traditional rehabilitation training; Other: Intelligent rehabilitation training

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 Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenlong Liu; Phone Number: 13261993917; Email: zhenlong_liu@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Zhenlong Liu; Phone Number: 13261993917; Email: zhenlong_liu@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Combination of traditional rehabilitation and intelligent rehabilitation	Other: Artificial and intelligent combination of shoulder joint function exercise; Rehabilitation therapist rehabilitation and intelligent rehabilitation are combined; Other Names: Experimental group
Experimental: Traditional rehabilitation group; Rehabilitation training by a rehabilitation therapist	Other: Traditional rehabilitation training; Shoulder joint function training is performed by a rehabilitation therapist
Experimental: Smart rehabilitation group	Other: Intelligent rehabilitation training; Shoulder joint rehabilitation training is carried out according to the intelligent rehabilitation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 0、Week 4 and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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?"	Week 0 、Week 4 and Week 8

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 21, 2026
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Frozen Shoulder; functional exercise; Smart rehabilitation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Bursitis
• Other Study ID Numbers: M20251134

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