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Telerehabilitation of Patients After Knee Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Telerehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Future Patient - Telerehabilitation of Patients After Knee Surgery
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731208


Locations
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Denmark
Aalborg University
Aalborg, Denmark, 9220
Aalborg University Hospital
Farsø, Denmark, 9640
Sponsors and Collaborators
Aalborg University
Aalborg University Hospital
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03731208    
Other Study ID Numbers: N-20180012
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan for sharing protocol was considered.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammad Reza Naeemabadi, Aalborg University:
Quality of life
Telerehabilitation
Knee rehabilitation
Knee Osteoarthritis
Total Knee Replacement
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases