Knee OsteoarthritisNCT03731208
Telerehabilitation of Patients After Knee Surgery
A study testing Telerehabilitation in people with Knee Osteoarthritis, run by Aalborg University at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Telerehabilitation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aalborg University
Aalborg, 9220
Aalborg University Hospital
Farsø, 9640
About this study
Official title: Future Patient - 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Telerehabilitation
- Keywords
- Quality of life, Telerehabilitation, Knee rehabilitation, Knee Osteoarthritis, Total Knee Replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationDevice
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation Receives: Device: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the telerehabilitation program: semi-structured interview
The data is collected by a semi-structured interview
Measured: The interview is conducted two weeks after discharge.
Exercise adherence
Measured by telerehabilitation system reports
Measured: Everyday, started after discharge and for period of 8-weeks
Secondary outcomes (6)
Self-reported pain, stiffness, and physical function: KOOS
Measured using Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: After discharge (weeks 2, 8)
Self-reported pain and physical function: OKS
measured by an electronic version of Oxford Knee Score (OKS)
Measured: Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
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
Measured: Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Self-reported knee swelling
measured by an electronic report of knee circumference
Measured: Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Quality of life: EQ-5D
Measured using Euro Quality of Life - 5 Dimension (EQ-5D)
Measured: After discharge (weeks 2, 8)
Users satisfaction: semi-structured interview
Measured by semi-structured interview
Measured: The interview is conducted two weeks after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 May 2018
- Primary completion15 Jul 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Mohammad Reza Naeemabadi, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731208
- Sponsor's protocol ID
- N-20180012
- Status last verified
- Jul 2020
- First submitted
- 22 Sep 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing protocol was considered.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Patient - Telerehabilitation of Patients After Knee Surgery
- ClinicalTrials.gov ID
- NCT03731208
- Acronym / sponsor ID
- N-20180012
- Conditions
- Knee Osteoarthritis
- Keywords
- Quality of life, Telerehabilitation, Knee rehabilitation, Knee Osteoarthritis, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: TelerehabilitationThe patient assign to this arm receive the telerehabilitation program for 8-week after a knee operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe 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 | Device | Intervention group |
Primary outcome
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
6 secondary outcomes
Self-reported pain, stiffness, and physical function: KOOS
Time frame: After discharge (weeks 2, 8)
Self-reported pain and physical function: OKS
Time frame: Baseline (before operation), and after discharge (weeks 0,2,4,6,8)
Self-reported pain: VAS
Time frame: Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Self-reported knee swelling
Time frame: Baseline (before operation), and every third day after discharge (for period of 8 weeks)
Quality of life: EQ-5D
Time frame: After discharge (weeks 2, 8)
Users satisfaction: semi-structured interview
Time frame: The interview is conducted two weeks after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No. No plan for sharing protocol was considered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Knee Osteoarthritis, run by Aalborg University at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the telerehabilitation program: semi-structured interview (time frame: The interview is conducted two weeks after discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.