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Telerehabilitation of Patients After Knee Surgery

2020年7月7日 更新者:Mohammad Reza Naeemabadi、Aalborg University

Future Patient - Telerehabilitation of Patients After Knee Surgery

This project is aimed to investigate the feasibility of employing communication and sensor technologies for the patient after a knee operation.

In the study, it is hypothesized that the effectiveness of postoperative rehabilitation programs might be improved by establishing electronic communication between healthcare professionals and the patients. It is also believed that users satisfaction and patients quality of life will be improved.

The telerehabilitation program promises a synchronized communication as well as an individualized training program (by health professionals) based on the patient's electronic reports.

研究概览

地位

完全的

详细说明

Aim The objectives of this project are to assess the feasibility of using a telerehabilitation program for patients after a knee operation and investigate the acceptance of the provided solution by the patients and healthcare professionals.

Hypothesis It is hypothesized that the acceptance and satisfaction of patients and healthcare professionals by using the telerehabilitation program will be high and correlated with patients' exercise adherence and health recovery.

Telerehabilitation Group (Target Group) The subjects will be recruited before the operation and will be followed during an 8-week rehabilitation period.

In addition to the telerehabilitation program, the subjects will receive the regular treatment offered by Farsø Hospital in connection with total knee replacement surgery and are to follow the same rehabilitation procedure as regular patients (see below).

Before the operation, the project physiotherapist will hand over the telerehabilitation system equipment and instruct the subject how to use the system. In addition, the physiotherapist will also ask the subject to follow the instruction process and try the available services a few times. The physiotherapist makes sure that the subject can operate the system easily and without any challenges.

研究类型

介入性

注册 (实际的)

12

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。

学习地点

      • Aalborg、丹麦、9220
        • Aalborg University
      • Farsø、丹麦、9640
        • Aalborg University Hospital

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Aged over 18
  • Successful primary total knee replacement surgery at Farsø Hospital
  • Referred to the regular rehabilitation program (self-training at home) by the physiotherapists at Farsø Hospital
  • Ability to walk (with or without walking aids)
  • Able to use electronic technologies and devices (for example: smart phone, tablet) or at least one relative who can assist in this matter
  • Living in The North Denmark Region

Exclusion Criteria:

  • Previous or current drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous or current neurologic, musculoskeletal or mental illnesses
  • Any other aggravating medical complication (such as infection or DVT)
  • Lack of ability to understand and accept trial procedures

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention group
The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation

The telerehabilitation program equipment consists of the following devices:

  • a tablet with a keyboard and a fingerprint sensor
  • two wearable sensors
  • a wireless modem
  • measuring tape

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
Usability of the telerehabilitation program: semi-structured interview
大体时间:The interview is conducted two weeks after discharge.
The data is collected by a semi-structured interview
The interview is conducted two weeks after discharge.
Exercise adherence
大体时间:Everyday, started after discharge and for period of 8-weeks
Measured by telerehabilitation system reports
Everyday, started after discharge and for period of 8-weeks

次要结果测量

结果测量
措施说明
大体时间
Self-reported pain, stiffness, and physical function: KOOS
大体时间:After discharge (weeks 2, 8)
Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)
After discharge (weeks 2, 8)
Self-reported pain and physical function: OKS
大体时间:Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
measured by an electronic version of Oxford Knee Score (OKS)
Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
Self-reported pain: VAS
大体时间:Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Measured by an electronic report of the visual analog scale (VAS) of pain [minimum 0, Maximum 10] higher values represent a higher level of pain
Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Self-reported knee swelling
大体时间:Baseline (before operation), and every third day after discharge (for period of 8 weeks)
measured by an electronic report of knee circumference
Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Quality of life: EQ-5D
大体时间:After discharge (weeks 2, 8)
Measured using Euro Quality of Life - 5 Dimension (EQ-5D)
After discharge (weeks 2, 8)
Users satisfaction: semi-structured interview
大体时间:The interview is conducted two weeks after discharge.
Measured by semi-structured interview
The interview is conducted two weeks after discharge.

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。

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 (实际的)

2018年5月1日

初级完成 (实际的)

2019年7月15日

研究完成 (实际的)

2020年7月1日

研究注册日期

首次提交

2018年9月22日

首先提交符合 QC 标准的

2018年11月5日

首次发布 (实际的)

2018年11月6日

研究记录更新

最后更新发布 (实际的)

2020年7月8日

上次提交的符合 QC 标准的更新

2020年7月7日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

No plan for sharing protocol was considered.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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