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临床试验/NCT03731208
NCT03731208已完成不适用

Future Patient - Telerehabilitation of Patients After Knee Surgery

Aalborg University4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
4
主要终点
Usability of the telerehabilitation program: semi-structured interview

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Usability of the telerehabilitation program: semi-structured interview

时间窗: The interview is conducted two weeks after discharge.

The data is collected by a semi-structured interview

Exercise adherence

时间窗: Everyday, started after discharge and for period of 8-weeks

Measured by telerehabilitation system reports

次要结局

  • Self-reported pain, stiffness, and physical function: KOOS(After discharge (weeks 2, 8))
  • Self-reported pain and physical function: OKS(Baseline (before operation), and after discharge (weeks 0,2,4,6,8))
  • Self-reported pain: VAS(Baseline (before operation), and every third day after discharge (for period of 8 weeks))
  • Self-reported knee swelling(Baseline (before operation), and every third day after discharge (for period of 8 weeks))
  • Quality of life: EQ-5D(After discharge (weeks 2, 8))
  • Users satisfaction: semi-structured interview(The interview is conducted two weeks after discharge.)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Reza Naeemabadi

Principal Investigator, Laboratory for Welfare Technologies - Telehealth & Telerehabilitation, Integrative Neuroscience Research Group, SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark

Aalborg University

研究点 (4)

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