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Completed

NCT Number: NCT03731208

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telerehabilitation

Device

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

Primary outcomes

  1. Usability of the telerehabilitation program: semi-structured interview

    Time frame: The interview is conducted two weeks after discharge.

    The data is collected by a semi-structured interview

  2. Exercise adherence

    Time frame: Everyday, started after discharge and for period of 8-weeks

    Measured by telerehabilitation system reports

Secondary outcomes

  1. Self-reported pain, stiffness, and physical function: KOOS

    Time frame: After discharge (weeks 2, 8)

    Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)

  2. Self-reported pain and physical function: OKS

    Time frame: Baseline (before operation), and after discharge (weeks 0,2,4,6,8)

    measured by an electronic version of Oxford Knee Score (OKS)

  3. Self-reported pain: VAS

    Time frame: 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

  4. Self-reported knee swelling

    Time frame: Baseline (before operation), and every third day after discharge (for period of 8 weeks)

    measured by an electronic report of knee circumference

  5. Quality of life: EQ-5D

    Time frame: After discharge (weeks 2, 8)

    Measured using Euro Quality of Life - 5 Dimension (EQ-5D)

  6. Users satisfaction: semi-structured interview

    Time frame: The interview is conducted two weeks after discharge.

    Measured by semi-structured interview

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Aalborg University Hospital

Registry information

Official study title

Future Patient - Telerehabilitation of Patients After Knee Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 6, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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