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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-60
SponsorPeking University Third Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Artificial and intelligent combination of shoulder joint function exercise

    Other intervention

    Rehabilitation therapist rehabilitation and intelligent rehabilitation are combined

  • Traditional rehabilitation training

    Other intervention

    Shoulder joint function training is performed by a rehabilitation therapist

  • Intelligent rehabilitation training

    Other intervention

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

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Traditional rehabilitation groupExperimental treatment 1 intervention
Group C: Smart rehabilitation groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

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