Telerehabilitation of Patients After Knee Surgery
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Quality of life, Telerehabilitation, Knee rehabilitation, Knee Osteoarthritis, Total Knee Replacement
Eligibility 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
Sites / Locations
- Aalborg University
- Aalborg University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation
Outcomes
Primary Outcome Measures
Usability of the telerehabilitation program: semi-structured interview
The data is collected by a semi-structured interview
Exercise adherence
Measured by telerehabilitation system reports
Secondary Outcome Measures
Self-reported pain, stiffness, and physical function: KOOS
Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)
Self-reported pain and physical function: OKS
measured by an electronic version of Oxford Knee Score (OKS)
Self-reported pain: VAS
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
measured by an electronic report of knee circumference
Quality of life: EQ-5D
Measured using Euro Quality of Life - 5 Dimension (EQ-5D)
Users satisfaction: semi-structured interview
Measured by semi-structured interview
Full Information
NCT ID
NCT03731208
First Posted
September 22, 2018
Last Updated
July 7, 2020
Sponsor
Aalborg University
Collaborators
Aalborg University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03731208
Brief Title
Telerehabilitation of Patients After Knee Surgery
Official Title
Future Patient - Telerehabilitation of Patients After Knee Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Aalborg University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Quality of life, Telerehabilitation, Knee rehabilitation, Knee Osteoarthritis, Total Knee Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation
Intervention Type
Device
Intervention Name(s)
Telerehabilitation
Intervention Description
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 Measure Information:
Title
Usability of the telerehabilitation program: semi-structured interview
Description
The data is collected by a semi-structured interview
Time Frame
The interview is conducted two weeks after discharge.
Title
Exercise adherence
Description
Measured by telerehabilitation system reports
Time Frame
Everyday, started after discharge and for period of 8-weeks
Secondary Outcome Measure Information:
Title
Self-reported pain, stiffness, and physical function: KOOS
Description
Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
After discharge (weeks 2, 8)
Title
Self-reported pain and physical function: OKS
Description
measured by an electronic version of Oxford Knee Score (OKS)
Time Frame
Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
Title
Self-reported pain: VAS
Description
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
Time Frame
Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Title
Self-reported knee swelling
Description
measured by an electronic report of knee circumference
Time Frame
Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Title
Quality of life: EQ-5D
Description
Measured using Euro Quality of Life - 5 Dimension (EQ-5D)
Time Frame
After discharge (weeks 2, 8)
Title
Users satisfaction: semi-structured interview
Description
Measured by semi-structured interview
Time Frame
The interview is conducted two weeks after discharge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Aalborg University
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark
Facility Name
Aalborg University Hospital
City
Farsø
ZIP/Postal Code
9640
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan for sharing protocol was considered.
Learn more about this trial
Telerehabilitation of Patients After Knee Surgery
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