Mobile Device Based Telerehabilitation for Frozen Shoulder-A Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change shoulder active range of motion in degree
研究概览
简要总结
Abstract
Introduction Frozen shoulder is a common musculoskeletal disorder with reported lifetime prevalence to be 2%~5% in the general population. Patients with frozen shoulders present with chronic pain and limited range of motion of affected shoulder and often cause an adverse impact on their daily activities and working ability. Shoulder exercises had been proven to be effective in treatment of frozen shoulders and the effects were even better after intraarticular corticosteroid injection. Strategies to enhance home exercise for patients with frozen shoulders are essential.
Objective To compare the effects of home exercises delivered by a newly developed app named Defrozen app with that by convention home exercise for frozen shoulder patients after intra-articular corticosteroid injection.
Methods and analysis This is a randomized, controlled, assessor-blinded clinical trial. Seventy-eight individuals diagnosed with frozen shoulders will be randomly divided into two groups. The primary outcome will be shoulder passive range of motion (measured with a universal goniometer). The secondary outcomes will include , shoulder pain evaluated by 11-point numeric rating scale , Oxford shoulder score and Disabilities of the arm, shoulder and hand questionnaire. Feasibility of the app includes including Technology Acceptance Model (TAM-2), System Usability Scale (SUS) and Usability, Satisfaction and Ease of Use (USE) questionnaire . The treatment will be conducted for 6 months (Defrozen app home exercise x conventional home exercise by instructions from printed pamphlets).All participants will receive outcome measurements assessment prior to randomization , 4 weeks , 12 weeks after injections interventions. Feasibility will be evaluated 4 weeks after intervention in the Defrozen app group.
Ethics and dissemination The study protocol was approved by the Institutional Review Board. The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
详细描述
The primary objective of this study is to test the hypothesis that a 12-week frozen shoulder exercise program delivered through the mobile app will result in greater improvement in shoulder range of motion compared to the control group. The control group will receive conventional home exercises provided on paper for patients with frozen shoulder after undergoing intra-articular corticosteroid injection.The secondary objective is to assess the differences in range of motion and functional outcomes between the two groups of patients. Additionally, the feasibility and acceptability of the Defrozen-App to these patients will be evaluated.
This study will employ a prospective, two-armed, assessor-blinded superiority randomized controlled trial design to compare two parallel groups of patients with primary frozen shoulder. The study was designed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for planning interventional trials. The trial results will be reported following the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
This study will be conducted in the northern branch of a medical system, which includes three hospitals located in northern Taiwan. The trial is registered [provide registration number or leave it blank if not available]. The recruitment of patients will take place in the clinic of the Department of Physical Medicine and Rehabilitation at Chang Gung Memorial Hospital, Taipei, Linko, and Taoyuan branches.
A Mobile Phone App for Demonstrating Home Exercises for Frozen Shoulder:
The Defrozen app is designed to provide simple home exercise programs for patients with frozen shoulders. It includes various features such as a training mode with exercise demonstrations, an exercise calendar, and pain evaluation.The main screen of the app displays exercise videos that are demonstrated by one of our researchers. It consists of seven sets of exercises specifically selected by physicians and a physiotherapist in our team. These exercises include Finger Walk for shoulder flexion and abduction, self-stretching exercises for shoulder external rotation and pectoral muscles, and crossover arm stretch for shoulder adduction. Additionally, towel exercises for shoulder extension and internal rotation are included. Each set of exercises consists of 10 repetitions, and we recommend performing four sessions per day. The total exercise time for one session is approximately 8 minutes. We encourage users to follow the exercise demonstrations provided in the app.After completing the exercise mode, the app prompts the patient to indicate whether they have completed the exercise and record their current pain intensity on a scale ranging from 0 to 10 . The app then transitions to the calendar mode, which displays the number of exercise sessions completed on that day and reminds the patient of the remaining sessions to be completed.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor blind to the arm of the subjects
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
App intervention group
Patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The APP intervention group will be guided through the exercises using the mobile app. Each set of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day.
干预措施: Nonsteroidal anti-inflammatory drugs (aceclofenac) (Drug)
App intervention group
Patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The APP intervention group will be guided through the exercises using the mobile app. Each set of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day.
干预措施: Glenohumeral joint and subacromial space triamcinolone injections (Drug)
App intervention group
Patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The APP intervention group will be guided through the exercises using the mobile app. Each set of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day.
干预措施: App-assisted exercise (Device)
Conventional group
patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The conventional group will be provided with a printed pamphlet illustrating the exercises. Each set of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day.
干预措施: Glenohumeral joint and subacromial space triamcinolone injections (Drug)
Conventional group
patients will receive instructions on performing the seven sets of frozen shoulder exercises mentioned earlier. The conventional group will be provided with a printed pamphlet illustrating the exercises. Each set of exercises will involve 10 repetitions, and it is recommended to perform four sessions per day.
干预措施: Nonsteroidal anti-inflammatory drugs (aceclofenac) (Drug)
结局指标
主要结局
Change shoulder active range of motion in degree
时间窗: prior to randomization, 4-weeks after interventions and 12-weeks after intervention
The range of motion of the shoulder will be assessed using a universal goniometer, which measures the angle of movement between specific bone landmarks. The investigator will evaluate the active range of motion of the affected shoulder, including flexion, abduction, internal rotation, and external rotation, using the goniometer to determine the degrees of movement in each direction. Active range of movement of the affected shoulder, including flexion, abduction, internal rotation, and external rotation, will be measured by goniometer in degree.
次要结局
- Change of Shoulder pain by Numeric Rating Scale (NRS)(prior to randomization, 4-weeks after interventions and 12-weeks after intervention)
- Change of Oxford shoulder score (OSS).(prior to randomization, 4-weeks after interventions and 12-weeks after intervention)
- Change of Quick Disability of the Arm, Shoulder and Head (QuickDASH) score(prior to randomization, 4-weeks after interventions and 12-weeks after intervention)
- Selected part of revised Technology Acceptance Model (TAM-2)(4 weeks after intervention in App intervention group)
- System Usability Scale (SUS)(4 weeks after intervention in App intervention group)
- Usability, Satisfaction and Ease of Use (USE) questionnaire(4 weeks after intervention in App intervention group)
研究者
Chih-Chi ,Chen
Principle investigator
Chang Gung Memorial Hospital