Taipei Medical University
Taipei, 11031, Taiwan
NCT Number: NCT07723755
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.
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Interventional
Not applicable
Taipei, 11031, Taiwan
**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**
**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:
**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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Core Intervention: Participants are provided with an interactive digital device (an iPhone) equipped with the specialized "HappyGoGo" interactive rehabilitation software.
Home Exercise Regimen: Patients are instructed to use the device to perform 15 minutes of home exercise daily. The software utilizes gamified scenarios to guide them through specific movements, including shoulder flexion, abduction, push/pull, internal/external rotation, and elbow flexion.
Monitoring and Data Collection: As the patient exercises, the device tracks real-time movement data, such as joint angles and movement trajectories. This data is automatically uploaded to a cloud server, allowing the medical team to remotely monitor the patient's exercise form, execution quality, and daily compliance.
Standard Care Included: In addition to the home device, participants also receive standard hospital-based physical therapy (manual therapy, electrotherapy, and thermotherapy) twice a week.
Core Intervention: Participants receive standard home exercise education from the clinical staff, utilizing conventional verbal and written instructions. They do not receive the interactive digital device.
Standard Care Included: Like the experimental group, these participants continue to receive standard hospital-based physical therapy (manual therapy, electrotherapy, and thermotherapy) twice a week.
Time frame: Evaluated at exactly two time points: Baseline (Pre-test): Prior to the start of the intervention. 4 Weeks (Post-test): At the conclusion of the 4-week study period.
Range of Motion for flexion, abduction, rotation
Time frame: Evaluated at exactly two time points: Baseline (Pre-test): Prior to the start of the intervention. 4 Weeks (Post-test): At the conclusion of the 4-week study period.
Reduction in pain levels
Time frame: Evaluated at exactly two time points: Baseline (Pre-test): Prior to the start of the intervention. 4 Weeks (Post-test): At the conclusion of the 4-week study period.
DASH questionnaire
Time frame: Evaluated at exactly two time points: Baseline (Pre-test): Prior to the start of the intervention. 4 Weeks (Post-test): At the conclusion of the 4-week study period.
Functional strength
Time frame: Evaluated at exactly two time points: Baseline (Pre-test): Prior to the start of the intervention. 4 Weeks (Post-test): At the conclusion of the 4-week study period.
SF-36 scale
Time frame: Continuous / Daily throughout the entire 4-week intervention period.
Tracking instances where pain exceeds VAS > 5 or exertion exceeds RPE > 9
Time frame: ontinuous / Daily throughout the entire 4-week intervention period.
Tracking if the patient can consistently complete >40% of the daily home exercise program
Taipei Medical University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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