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Telerehabilitation of Patients After Knee Surgery

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ClinicalTrials.gov Identifier: NCT03731208
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Aalborg University Hospital
Information provided by (Responsible Party):
Mohammad Reza Naeemabadi, Aalborg University

Tracking Information
First Submitted Date  ICMJE September 22, 2018
First Posted Date  ICMJE November 6, 2018
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE May 1, 2018
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • 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
  • Exercise adherence [ Time Frame: Everyday, started after discharge and for period of 8-weeks ]
    Measured by telerehabilitation system reports
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • Self-reported pain, stiffness, and physical function: KOOS [ Time Frame: After discharge (weeks 2, 8) ]
    Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)
  • 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)
  • 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
  • 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
  • Quality of life: EQ-5D [ Time Frame: After discharge (weeks 2, 8) ]
    Measured using Euro Quality of Life - 5 Dimension (EQ-5D)
  • Users satisfaction: semi-structured interview [ Time Frame: The interview is conducted two weeks after discharge. ]
    Measured by semi-structured interview
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Self-reported pain, stiffness, and physical function: KOOS [ Time Frame: Baseline (before operation), and after discharge (weeks 2, 8) ]
    Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)
  • 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)
  • 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
  • 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
  • Quality of life: EQ-5D [ Time Frame: Baseline (before operation), and after discharge (weeks 2 , 8) ]
    Measured using Euro Quality of Life - 5 Dimension (EQ-5D)
  • Users satisfaction: semi-structured interview [ Time Frame: The interview is conducted two weeks after discharge. ]
    Measured by semi-structured interview
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telerehabilitation of Patients After Knee Surgery
Official Title  ICMJE Future Patient - Telerehabilitation of Patients After Knee Surgery
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Device: Telerehabilitation

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
Study Arms  ICMJE Experimental: Intervention group
The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation
Intervention: Device: Telerehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03731208
Other Study ID Numbers  ICMJE N-20180012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan for sharing protocol was considered.
Responsible Party Mohammad Reza Naeemabadi, Aalborg University
Study Sponsor  ICMJE Aalborg University
Collaborators  ICMJE Aalborg University Hospital
Investigators  ICMJE Not Provided
PRS Account Aalborg University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP