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

NCT07723755 | Completed

• 2 other identifiers: N202312062112TMUH-P-12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Frozen Shoulder; Adhesive Capsulitis

Outcome Measures

Primary Outcomes (2)

• Joint angle measurements

  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

  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 Outcomes (3)

• Upper limb function

  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

  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

  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 Outcomes (2)

• Adverse events/Pain exacerbation

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

• Device compliance rate

  ontinuous / Daily throughout the entire 4-week intervention period.

Study Arms (2)

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.

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.

Device: "HappyGoGo" interactive rehabilitation software; Behavioral: Standard home exercise education alongside standard hospital physical therapy

Interventions

"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.

Control Group; Home Interactive Device Intervention Group

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.

Control Group; Home Interactive Device Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 11031, Taiwan

Location

Related Publications (10)

• 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.

  PMID: 30610428 BACKGROUND

• Chen 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.

  PMID: 33902646 BACKGROUND

• Lee 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.

  PMID: 36573031 BACKGROUND

• Steiner 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.

  PMID: 32777826 BACKGROUND

• Malliaras 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.

  PMID: 33206059 BACKGROUND

• Cho 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.

  PMID: 31475043 BACKGROUND

• Robinson 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.

  PMID: 28318848 BACKGROUND

• Mertens 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.

  PMID: 34425089 BACKGROUND

• Cubukcu 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.

  PMID: 31882393 BACKGROUND

• Gupta, 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

  BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: April 23, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 23, 2026

Record last verified: 2026-06

Locations

TW (1)