The PROTECT-study: Home-based Telerehabilitation in the Post-operative Care After Shoulder Arthroplasty Compared to Usual Care: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative
研究概览
简要总结
The goal of this clinical trial is to compare the rehabilitation by use of a smartphone-app with the usual care of physical therapy in patients, 60 years and older, who underwent a primary shoulder arthroplasty.
The main questions it aims to answer are:
- is the outcome of rehabilitation with the app as good as the usual care?
- is the outcome for both types of shoulder arthroplasty similar?
- what is the usability of the app?.
Participants will
- have treatment according to the group they are allocated to
- fill in questionnaires at specific moments during the rehabilitation stage (0 - 3 months ) and at 1 year post-surgery
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years and older
- •primary total shoulder arthroplasty (anatomical and reverse)
- •osteoarthritis, cuff tear arthropathy, pseudoparalysis
- •return home after discharge from hospital
- •no brace after surgery
- •sufficient verbal and written comprehension
- •hospitalization insurance
排除标准
- •revision arthroplasty
- •arthroplasty for fracture or tumor
- •neurological disease (parkinson, stroke, ...)
- •no access to smartphone, tablet or internet connectivity
结局指标
主要结局
SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline pre-operative
时间窗: Prior to surgery
Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder
SHOULDER PAIN AND DISABILITY INDEX (SPADI)
时间窗: week 52
Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder
SHOULDER PAIN AND DISABILITY INDEX (SPADI)_baseline post-operative
时间窗: week 0
Content: 5 questions for the subscale pain and 8 questions for the disability subscale. Scoring: numeric rating scale from 1 to 10, with a maximum of 130. The total score is the sum of the sub-scores. Interpretation: The higher the score the more pain and disability. The lower the score, the better patients perceive their shoulder
次要结局
- PASSIVE MOBILITY (ROM) OF THE SHOULDER(Prior to surgery, week 3, week 6, week 12, week 52)
- STRENGTH(Prior to surgery, week 3, week 6, week 12, week 52)
- CONSTANT-MURLEY SCORE(Prior to surgery, week 3, week 6, week 12, week 52)
- ACTIVITIES OF DAILY LIVING EXTERNAL AND INTERNAL ROTATIONS (ADLEIR)(Prior to surgery, week 3, week 6, week 12, week 52)
- EUROQOL 5-DIMENSIONS 5-LEVEL (EQ-5D-5L)(Prior to surgery, week 3, week 6, week 12, week 52)
- SINGLE ASSESSMENT NUMERIC EVALUATION (SANE)(Prior to surgery, week 3, week 6, week 12, week 52)
- GRONINGEN ACTIVITY RESTRICTION SCALE (GARS-4)(Prior to surgery, week 3, week 6, week 12, week 52)
- EXERCISE ADHERENCE RATING SCALE (EARS)(Prior to surgery, week 3, week 6, week 12, week 52)
- EXERCISE DIARY(Daily post-surgery (week 0 - week 12))
- SELF-EFFICACY FOR EXERCISES (SEE)(Week 3, week 6, week 12, week 52)
- GLOBAL RATING OF CHANGE SCALE (GROC)(Prior to surgery, week 3, week 6, week 12, week 52)
- GLOBAL PERCEIVED EFFECT (GPE/GEE)(Prior to surgery, week 3, week 6, week 12, week 52)
- ACTIVE MOBILITY (ROM) OF THE SHOULDER(Prior to surgery, week 3, week 6, week 12, week 52)