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Completed

NCT Number: NCT07723755

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 11031, Taiwan

About this study

**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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have a formal clinical diagnosis of adhesive capsulitis (frozen shoulder).

Exclusion criteria

-

Treatment and study plan

"HappyGoGo" interactive rehabilitation software

Device

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.

Standard home exercise education alongside standard hospital physical therapy

Behavioral

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.

Primary outcomes

  1. Joint angle measurements

    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

  2. Pain records

    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

Secondary outcomes

  1. Upper limb function

    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

  2. Grip strength tests

    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

  3. Quality of life survey

    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

Other outcomes

  1. Adverse events/Pain exacerbation

    Time frame: Continuous / Daily throughout the entire 4-week intervention period.

    Tracking instances where pain exceeds VAS > 5 or exertion exceeds RPE > 9

  2. Device compliance rate

    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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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