肩峰下综合征远程康复计划的有效性 (Telerehab Sis) (telerehab)
2016年10月10日 更新者：Jose Manuel Pastora Bernal
与传统疗法相比，肩峰下综合征手术后远程康复计划的有效性。随机临床试验 (Telerehab)
肩痛在普通人群中很常见且患病率很高。
肩峰下综合征（肩峰撞击综合征 (SIS)）是最常见的原因。
SIS 患者在受影响的关节中遭受疼痛、肌肉无力和运动丧失。
SIS 的初始治疗主要是保守治疗。
手术选择具有很高的成功率，通常在保守策略失败时使用。
需要传统的物理治疗和术后锻炼来恢复关节范围、肌肉力量、稳定性和功能。
与传统疗法相比，本研究评估了手术后 SIS 远程康复计划的可行性和有效性。
研究概览
详细说明
除传统物理疗法外，远程康复项目已证明其在各种神经、认知疾病和肌肉骨骼疾病中的有效性、有效性、非劣效性和重要优势；这意味着定义新的社会和干预政策的机会。
受试者被随机分配到 1) 远程康复组 2) 传统治疗组。 随机分组后，两组患者均接受了初步评估。 数据将由盲法评估员收集。
远程康复小组通过一个网络应用程序接收标准化和定制的练习来执行，该应用程序允许物理治疗师生成每个练习程序的视频、图像和参数，并通过电子邮件为每个患者发送。
远程康复计划描述了要进行的练习，重复次数取决于训练水平和进展标准。
患者最初由一名物理治疗师监督，他将通过个人视频会议进行三个培训课程，以确保正确执行练习并鼓励患者坚持。 指导患者按照远程康复计划以及我们称为远程康复手册患者的支持文件进行自我锻炼视频练习。
传统组通过西班牙的常规康复程序在物理治疗中心获得帮助，个性化治疗包括与物理治疗师一对一的治疗和在家锻炼计划。
研究类型
介入性
注册 (预期的)
138
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jose Manuel Pastora Bernal
- 电话号码：0034 658561622
- 邮箱：jmpastora@uma.es
研究联系人备份
- 姓名：Jose Manuel Pastora Bernal
- 电话号码：0034 658561622
- 邮箱：jospasber@uma.es
学习地点
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Malaga、西班牙
- 招聘中
- Faculty of Health Sciences Universidad de Málaga
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接触：
- Jose Manuel Pastora-Bernal
- 电话号码：0034658561622
- 邮箱：jmpastora@uma.es
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 18 至 65 岁的成年人
- 肩峰下综合症诊断 ICD-9 CM 726.10, 726.12, 726.19 由整形外科和康复专家发布
- 接受外科手术（关节镜检查或开放手术（肩峰下减压与部分肩峰成形术，有或没有喙肩峰松解）和康复过程的处方。
- 他在调查期间居住在西班牙
- 提供带互联网技术的家用电脑（个人电脑、笔记本电脑、平板电脑或智能手机）
- 访问电子邮件的技能和知识
排除标准：
- 以前在同一肩部进行过手术干预。
- 根据肩峰下综合征的建议接受非手术治疗的患者
- 不适合使用技术工具的认知能力
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：远程康复
远程康复小组通过网络应用程序接收标准化和定制的练习，该应用程序允许物理治疗师生成每个练习程序的视频、图像和参数，并通过电子邮件为每个患者发送。
患者最初由物理治疗师监督，他们将进行视频会议，以确保正确执行锻炼并鼓励患者坚持。
|
远程康复计划后的初始视频会议在视频支持下进行自我锻炼。
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有源比较器：传统理疗
传统物理治疗组通过西班牙的常规康复程序在物理治疗中心获得帮助，包括与物理治疗师一对一的个性化治疗和家庭锻炼计划。
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传统物理疗法在物理治疗中心接受个性化治疗的帮助，包括与物理治疗师一对一（手法治疗、家庭锻炼计划和其他物理治疗技术）。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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简单肩部测试 (SST) 分数的变化
大体时间：初始、4周、8周和12周
|
Simple Shoulder Test 是一种经过验证的工具，具有 12 个一维问题的二分法（是/否）答案。
这是一份简短的问卷（2-3 分钟），易于理解和完成，与其他主观问卷相比具有有效性和可比性。
12 个问题的总分（2 个与疼痛有关，7 个与力有关，3 个与运动范围有关），其中 0 是最差的结果，100 是最好的肩部功能，根据乘以积极回答的数量计算100。
问卷。
测验的内部一致性采用 Cronbach's alpha = 0.85 衡量。
我们将评估此测试分数的变化。
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初始、4周、8周和12周
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Constant Shoulder 测试分数的变化
大体时间：初始、4周、8周和12周
|
恒定评分是一种普遍使用和接受的肩部功能评估工具。
它包括对疼痛和进行日常活动（工作、运动、梦想和手在空间中的定位）能力的主观评估，以及通过体格检查对灵活性和力量的客观评估。
我们将评估此测试分数的变化。
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初始、4周、8周和12周
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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远程医疗满意度和实用性问卷 (TSUQ)（西班牙文改编版）
大体时间：12周
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远程医疗应用程序的接受度和可用性是确定该技术潜在临床益处的先决条件。
因此，重要的是用工具来补充这项研究，以检查患者的满意度和看法。
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12周
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直接和间接成本
大体时间：12周
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这种经济分析是基于卫生部门的角度，这意味着只考虑那些用于健康干预的成本，而与患者无关的成本。
因此，只考虑与传统理疗组远程康复中提供健康服务相关的成本。
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12周
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jose Manuel Pastora Bernal、University of Malaga
- 研究主任：Rocio Martín Valero、University of Malaga
- 研究主任：Francisco Javier Barón López、University of Malaga
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (预期的)
2017年3月1日
研究完成 (预期的)
2017年5月1日
研究注册日期
首次提交
2016年9月14日
首先提交符合 QC 标准的
2016年9月16日
首次发布 (估计)
2016年9月21日
研究记录更新
最后更新发布 (估计)
2016年10月11日
上次提交的符合 QC 标准的更新
2016年10月10日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
肩部撞击综合征的临床试验
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Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research Foundation; Cornelia... 和其他合作者招聘中线粒体疾病 | 色素性视网膜炎 | 重症肌无力 | 嗜酸性胃肠炎 | 多系统萎缩 | 平滑肌肉瘤 | 脑白质营养不良 | 肛瘘 | 脊髓小脑性共济失调3型 | 弗里德赖希共济失调 | 肯尼迪病 | 莱姆病 | 噬血细胞性淋巴组织细胞增生症 | 脊髓小脑性共济失调1型 | 脊髓小脑性共济失调2型 | 脊髓小脑共济失调6型 | 威廉姆斯综合症 | 先天性巨结肠症 | 糖原贮积病 | 川崎病 | 短肠综合症 | 低磷血症 | Leber先天性黑蒙 | 口臭 | 贲门失弛缓症 | 多发性内分泌肿瘤 | 利综合症 | 艾迪生病 | 多发性内分泌肿瘤 2 型 | 硬皮病 | 多发性内分泌肿瘤 1 型 | 多发性内分泌肿瘤 2A 型 | 多发性内分泌肿瘤 2B 型 | 非典型溶血性尿毒症综合征 | 胆道闭锁 | 痉挛性共济失调 | WAGR综合症 | 无虹膜 | 短暂性失忆症 | 马尾综合症 | Refsum 疾病 | 复发性呼吸... 及其他条件美国, 澳大利亚