Frozen ShoulderNCT07723755
The Effectiveness of Using Interactive Devices for Home Exercise in Patients With Frozen Shoulder.
A study testing "HappyGoGo" interactive rehabilitation software and Standard home exercise education alongside standard hospital physical therapy in people with Frozen Shoulder and Adhesive Capsulitis, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frozen Shoulder, Adhesive Capsulitis
- What is being tested?
- "HappyGoGo" interactive rehabilitation software and Standard home exercise education alongside standard hospital physical therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Apr 2024to 31 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient must have a formal clinical diagnosis of adhesive capsulitis (frozen shoulder).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Frozen Shoulder, Adhesive Capsulitis
- Being tested
- "HappyGoGo" interactive rehabilitation software, Standard home exercise education alongside standard hospital physical therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"HappyGoGo" interactive rehabilitation softwareDevice
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Interactive Device Intervention Group | Experimental | 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. Receives: Device: "HappyGoGo" interactive rehabilitation software; Behavioral: Standard home exercise education alongside standard hospital physical therapy |
| Control Group | Active comparator | 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. Receives: Behavioral: Standard home exercise education alongside standard hospital physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint angle measurements
Range of Motion for flexion, abduction, rotation
Measured: 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
Reduction in pain levels
Measured: 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 outcomes (3)
Upper limb function
DASH questionnaire
Measured: 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
Functional strength
Measured: 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
SF-36 scale
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start23 Apr 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723755
- Sponsor's protocol ID
- N202312062
- Other IDs
- 112TMUH-P-12
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ho TH, Yang FC, Lin RC, Chien WC, Chung CH, Chiang SL, Chou CH, Tsai CK, Tsai CL, Lin YK, Lee JT. Impact of virtual reality-based rehabilitation on functional outcomes in patients with acute stroke: a retrospective case-matched study. J Neurol. 2019 Mar;266(3):589-597. doi: 10.1007/s00415-018-09171-2. Epub 2019 Jan 4.
PubMed 30610428Chen SC, Lin CH, Su SW, Chang YT, Lai CH. Feasibility and effect of interactive telerehabilitation on balance in individuals with chronic stroke: a pilot study. J Neuroeng Rehabil. 2021 Apr 26;18(1):71. doi: 10.1186/s12984-021-00866-8.
PubMed 33902646Lee Y, Jung KB. Effect of Physiotherapy to Correct Rounded Shoulder Posture in 30 Patients During the COVID-19 Pandemic in South Korea Using a Telerehabilitation Exercise Program to Improve Posture, Physical Function, and Reduced Pain, with Evaluation of Patient Satisfaction. Med Sci Monit. 2022 Dec 27;28:e938926. doi: 10.12659/MSM.938926.
PubMed 36573031Steiner B, Elgert L, Saalfeld B, Schwartze J, Borrmann HP, Kobelt-Ponicke A, Figlewicz A, Kasprowski D, Thiel M, Kreikebohm R, Haux R, Wolf KH. Health-Enabling Technologies for Telerehabilitation of the Shoulder: A Feasibility and User Acceptance Study. Methods Inf Med. 2020 Dec;59(S 02):e90-e99. doi: 10.1055/s-0040-1713685. Epub 2020 Aug 10.
PubMed 32777826Malliaras P, Cridland K, Hopmans R, Ashton S, Littlewood C, Page R, Harris I, Skouteris H, Haines T. Internet and Telerehabilitation-Delivered Management of Rotator Cuff-Related Shoulder Pain (INTEL Trial): Randomized Controlled Pilot and Feasibility Trial. JMIR Mhealth Uhealth. 2020 Nov 18;8(11):e24311. doi: 10.2196/24311.
PubMed 33206059Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.
PubMed 31475043Robinson PM, Norris J, Roberts CP. Randomized controlled trial of supervised physiotherapy versus a home exercise program after hydrodilatation for the management of primary frozen shoulder. J Shoulder Elbow Surg. 2017 May;26(5):757-765. doi: 10.1016/j.jse.2017.01.012. Epub 2017 Mar 18.
PubMed 28318848Mertens MG, Meert L, Struyf F, Schwank A, Meeus M. Exercise Therapy Is Effective for Improvement in Range of Motion, Function, and Pain in Patients With Frozen Shoulder: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2022 May;103(5):998-1012.e14. doi: 10.1016/j.apmr.2021.07.806. Epub 2021 Aug 21.
PubMed 34425089Cubukcu B, Yuzgec U, Zileli R, Zileli A. Reliability and validity analyzes of Kinect V2 based measurement system for shoulder motions. Med Eng Phys. 2020 Feb;76:20-31. doi: 10.1016/j.medengphy.2019.10.017. Epub 2019 Dec 25.
PubMed 31882393Gupta, A., Shrestha, P. L., Thapa, B., Silwal, R., & Shrestha, R. (2023). Knee Flexion/Extension Angle Measurement for Gait Analysis Using Machine Learning Solution "MediaPipe Pose" and Its Comparison with Kinovea® . IOP Conf. Series: Materials Science and Engineering, 1279(1), 012004. doi:10.1088/1757- 899X/1279/1/012004