The Effectiveness of Using Interactive Devices for Home Exercise in Patients With Frozen Shoulder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Joint angle measurements
研究概览
简要总结
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.
详细描述
**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**
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have a formal clinical diagnosis of adhesive capsulitis (frozen shoulder).
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: "HappyGoGo" interactive rehabilitation software (Device)
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.
干预措施: Standard home exercise education alongside standard hospital physical therapy (Behavioral)
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.
干预措施: Standard home exercise education alongside standard hospital physical therapy (Behavioral)
结局指标
主要结局
Joint angle measurements
时间窗: 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
Pain records
时间窗: 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
次要结局
- 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.)