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

July 19, 2026 updated by: Taipei Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

**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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11031
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home Interactive Device Intervention Group

Participants receive standard hospital-based physical therapy (which includes manual therapy, electrotherapy, and thermotherapy) twice a week.

They are provided with an iPhone equipped with the "HappyGoGo" interactive rehabilitation software.

They are instructed to use the device to perform 15 minutes of daily home exercise guided by gamified scenarios.

The guided movements include shoulder flexion, abduction, push/pull, internal/external rotation, and elbow flexion.

The device tracks the patient's movements (such as joint angles and trajectories) and uploads the data to a cloud server, allowing the medical team to remotely monitor execution quality and compliance.
Device: "HappyGoGo" interactive rehabilitation software

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.

Behavioral: Standard home exercise education alongside standard hospital physical therapy

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.
Active Comparator: Control Group

Participants receive the same standard hospital-based physical therapy (manual therapy, electrotherapy, and thermotherapy) twice a week.

They do not receive the interactive digital device.

Instead, they receive standard home exercise education and instructions provided by the clinical staff.
Device: "HappyGoGo" interactive rehabilitation software

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.

Behavioral: Standard home exercise education alongside standard hospital physical therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Continuous / Daily throughout the entire 4-week intervention period.
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
ontinuous / Daily throughout the entire 4-week intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2024

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

July 19, 2026

First Submitted That Met QC Criteria

July 19, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202312062
  • 112TMUH-P-12 (Other Grant/Funding Number: Taipei Medical University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adhesive Capsulitis

Clinical Trials on "HappyGoGo" interactive rehabilitation software

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe