The Effectiveness of Using Interactive Devices for Home Exercise in Patients With Frozen Shoulder.

Adhesive Capsulitis, Frozen Shoulder

This study is a randomized clinical trial designed to evaluate the effectiveness of using interactive digital devices to guide home exercise for patients with frozen shoulder (adhesive capsulitis). Background: While exercise therapy is a crucial treatment for improving joint mobility and reducing pain in frozen shoulder patients, ensuring proper technique and compliance during home exercises can be difficult. Methodology: The trial plans to enroll 30 participants, randomly assigning them to either an interactive device group or a control group. Both groups will undergo standard hospital rehabilitation twice a week. Intervention: The intervention group will be provided with an iPhone containing interactive rehabilitation software to perform 15 minutes of guided home exercise daily. The control group will receive standard home exercise education. Hypothesis: The study hypothesizes that after a 4-week period, the group utilizing the interactive device for home exercise will demonstrate superior improvements in pain, joint angle, grip strength, and quality of life compared to the control group.

\*\*Background and Rationale\*\* Frozen shoulder, formally known as adhesive capsulitis, is a condition causing restricted shoulder movement and significant pain, which severely impacts a patient's quality of life. The disease progression typically involves three stages: freezing, frozen, and thawing. While standard treatments include medication and physical therapy, exercise therapy-specifically home exercise-is a critical component for restoring joint mobility and muscle strength. However, patients often struggle with compliance and correct form when exercising unsupervised at home. This study introduces an interactive digital system to provide real-time guidance, movement monitoring, and immediate feedback to optimize home rehabilitation. \*\*Study Design\*\* The study is a randomized parallel experimental clinical trial. It plans to enroll 30 patients diagnosed with adhesive capsulitis from the Rehabilitation Medicine Outpatient Department. Participants are randomly assigned to either an interactive device intervention group (15 patients) or a control group (15 patients). The total intervention period for each participant is 4 weeks. \*\*Intervention Details\*\* * \*\*Interactive Device Group:\*\* Participants receive standard hospital physical therapy (including manual therapy, electrotherapy, and thermotherapy) twice a week. Additionally, they are provided an iPhone equipped with the "HappyGoGo" interactive rehabilitation software to perform 15 minutes of home exercise daily. The software uses gamified scenarios to guide patients through shoulder flexion, abduction, push/pull, internal/external rotation, and elbow flexion exercises. The system tracks movement, and post-session data (such as joint angles and movement trajectories) is uploaded to a cloud server, allowing the medical team to remotely review the patient's execution quality and daily compliance. * \*\*Control Group:\*\* Participants receive the same standard hospital physical therapy twice a week. Instead of the interactive device, they are given standard home exercise education by the clinical staff. \*\*Outcome Measures\*\* Both groups undergo a pre-test before the intervention begins and a post-test exactly 4 weeks later. The trial evaluates the following parameters to compare the clinical effectiveness of the two approaches: * Pain records. * Joint angle measurements. * Grip strength tests. * Upper limb function (assessed via the DASH questionnaire). * Quality of life (assessed via the SF-36 scale). \*\*Safety and Monitoring\*\* Safety is monitored both in the clinical setting and remotely. For the home exercise component, the assigned movements are low-intensity, and patients are thoroughly trained on the equipment in the hospital prior to taking it home. The medical team actively monitors for adverse events through phone follow-ups and data tracking. Home exercises are suspended or adjusted if a patient experiences significant pain (VAS \> 5), extreme exertion (RPE \> 9), or is consistently unable to complete more than 40% of the daily exercise program.

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