OsteoarthritisMOVEUP-WTNCT06157190
Incorporating Wearable Technology for Enhanced Rehabilitation Monitoring After Hip and Knee Replacement
An observational study of Osteoarthritis and Osteoarthritis, Hip, run by PXL University College at 1 site in Belgium.
Trial summary
This study focuses on the impact of osteoarthritis (OA), a leading cause of disability among older adults, with the hip and knee joints being particularly affected. The rise in OA prevalence is attributed to factors such as aging and increasing obesity rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Osteoarthritis, Hip
- What is being tested?
- Unsupervised monitoring
- How many people
- 1,144 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 30 Oct 2023
- Phase
- Observational
- 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
Study population: * Patients with Osteoarthritis (OA): The study focuses on individuals affected by osteoarthritis, a common degenerative joint condition. * Age Group: * Underwent Hip or Knee Replacement Surgery: The population includes individuals who have undergone either total hip arthroplasty or total knee arthroplasty. * Geographical Distribution: The dataset used for the study is from moveUP digital therapies and includes patients from Belgium, France, and the Netherlands. Therefore, the study population is likely diverse, representing patients from these regions. * Technology-Engaged Individuals:The study population engaged with technology-assisted rehabilitation through the moveUP digital therapies platform. * Minimum Post-Surgery Duration: Patients engaged with the technology-assisted rehabilitation for a minimum of six weeks post-surgery, indicating a focus on the early stages of the recovery process.
Who may be able to join
- Persons with Hip or Knee Replacement surgery
- minimum 18 years of age
- Patient has emailadres
- use of application for at least 6 weeks postop
- completion of preoperative questionnaire
Who cannot join
- Patient younger than 18 years of age
- no emailadres
Trial locations and contacts
1 site in 1 country.
About this study
This study focuses on the impact of osteoarthritis (OA), a leading cause of disability among older adults, with the hip and knee joints being particularly affected. The rise in OA prevalence is attributed to factors such as aging and increasing obesity rates. Post-surgery rehabilitation, especially after total hip or knee replacement, traditionally relies on supervised clinical assessments, which have limitations in capturing real-world experiences. The study aims to explore the integration of technology-assisted rehabilitation, utilizing wearable sensors and mobile health technologies, for unsupervised, real-world assessments. The use of digital biomarkers collected from these technologies offers continuous, objective measurements of patients' biological and physiological data. The research employs a dataset from moveUP digital therapies, including patients who underwent total knee arthroplasty, utilizing a digital application for at least six weeks post-surgery.
Key objectives include evaluating the potential of automated unsupervised assessments in providing a holistic understanding of patient progression during rehabilitation. The study utilizes mixed models for statistical analysis, examining outcomes such as steps per day, 6-minute walk test, and peak 1 minute. Results indicate differences in recovery trajectories between hip and knee patients, with variations based on gender and type of prosthesis.
Read the detailed description
Data Source:
This retrospective observational study utilized anonymized and depersonalized data from the moveUP digital therapies database (moveUP solution, Brussels, Belgium). The database encompasses information from patients who underwent hip and knee arthroplasty across Belgium, France, and the Netherlands. A cohort of 1144 patients who underwent elective total knee arthroplasty was selected based on their use of the digital application for a minimum of 6 weeks post-surgery, with completion of preoperative patient-reported outcome measures. Written informed consent for the scientific use of anonymized data was obtained from each patient. Regulatory guidelines were adhered to, and no institutional review board (IRB) approval was required, given the use of anonymized patient-level data.
Recording Device and Outcomes:
All data collection occurred through the moveUP® application, a registered medical device operating on a smart virtual platform designed for digital monitoring. This platform comprises a patient-facing mobile application and a web-based dashboard utilized by care providers. Objective data, including the number of steps per day and steps per minute, were collected using a commercial activity tracker (Garmin Vivofit 4) worn 24/7 by patients throughout the rehabilitation period. Patient-reported outcomes, such as the Oxford Knee Score, Forgotten Joint Score (FJS), Hip Osteoarthritis Outcome score (KOOS), Knee Osteoarthritis Outcome score (KOOS), UCLA Activity Scale (UCLA), and the EuroQol 5-Dimension (EQ5D), were measured before surgery and at various intervals up to two years post-surgery through the app.
Statistical Analysis:
We analyzed outcomes using mixed models for both knee and hip patients, treating values from each day as repeated measures. The model incorporated fixed effects related to recovery, days after surgery, age, gender, and the interaction between recovery and days. Our analysis employed fixed effects for recovery, days after surgery, and their interaction, with baseline measures normalized for comparability. Time needed to differentiate between recovery statuses was computed along with associated 95% confidence intervals. Statistical analyses were conducted at a significance level of 0.05 using RStudio (version 2023.09.0) with R version 4.4.2 and the LME4 package for mixed effect models.
- Conditions
- Osteoarthritis, Osteoarthritis, Hip
- Being tested
- Unsupervised monitoring
- Keywords
- wearable technology, rehabilitation monitoring
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsupervised monitoringOther
This study introduces technology-assisted rehabilitation for patients post-total hip or knee arthroplasty, utilizing wearable sensors and mobile health tech. The intervention includes:
Technology-Assisted Rehabilitation: Utilizing wearable sensors and mobile health technologies, the intervention promotes unsupervised, real-world assessments after total hip or knee replacement. It shifts from traditional supervised clinical assessments. The moveUP digital therapies platform, featuring a dedicated mobile app, acts as the primary interface for patients in rehabilitation.
Digital Biomarkers: The intervention involves gathering digital biomarkers from wearable sensors and mobile health tech. These biomarkers offer continuous, objective measurements of patients' biological and physiological data. Examples include mobility and activity level data.
| Study group | Role | What they receive |
|---|---|---|
| patients with knee replacement | The knee replacement patient cohort in this study consists of individuals who underwent Total Knee Arthroplasty (TKA) and utilized the moveUP digital application for at least six weeks post-surgery. The criteria include:
Total Knee Arthroplasty (TKA): Individuals who had surgical intervention for total knee replacement.
moveUP Digital Application Usage: Patients actively engaged with the moveUP digital therapies platform, using the associated application for rehabilitation. The application aids and monitors the recovery process.
Post-Surgery Duration of Six Weeks: To be part of the study, patients in this cohort used the digital application for a minimum of six weeks after knee replacement surgery. This duration aims to evaluate the effectiveness of technology-assisted rehabilitation during the critical early recovery phase. Receives: Other: Unsupervised monitoring | |
| patients with hip replacement | The hip replacement cohort likely comprises individuals who had total hip arthroplasty. Similar to the knee replacement cohort, inclusion criteria may involve using the moveUP digital application for at least six post-surgery weeks. Characteristics include:
Total Hip Arthroplasty (THA): Patients underwent surgical intervention for total hip replacement.
moveUP Digital Application Usage: Cohort members actively engaged with the moveUP digital therapies platform, utilizing the associated app for post-surgery rehabilitation.
Post-Surgery Duration of Six Weeks: To join the study, patients likely used the digital application for a minimum of six weeks post-hip replacement surgery. This period helps assess technology-assisted rehabilitation effectiveness during early recovery. Receives: Other: Unsupervised monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
steps per day
This parameter represents the daily step count of patients. Monitoring steps per day is a common metric for assessing mobility and physical activity during rehabilitation.
Measured: pre and 6 weeks post surgery
6 minute walking test
he 6-minute walk test is a standard measure of functional capacity and endurance. Patients are assessed on the distance they can walk in six minutes, providing valuable information about their cardiovascular and musculoskeletal function
Measured: pre and 6 weeks post surgery
Peak 1 Minute
Refers to the walking performance measured during a one-minute interval
Measured: pre and 6 weeks post surgery
Intensity
intensity of physical activity, specifically focusing on activities classified as moderate-to-vigorous. This parameter provides information about the intensity of patients' physical efforts during rehabilitation
Measured: pre and 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Sep 2020
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,144 participants (actual)
Sponsor and investigators
- Lead sponsor
- PXL University College
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157190
- Sponsor's protocol ID
- PXLuc
- Acronym
- MOVEUP-WT
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Wearable Technology for Enhanced Rehabilitation Monitoring After Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT06157190
- Acronym / sponsor ID
- MOVEUP-WT / PXLuc
- Conditions
- Osteoarthritis, Osteoarthritis, Hip
- Keywords
- wearable technology, rehabilitation monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,144 participants (actual)
- Lead sponsor
- PXL University CollegeUniversity, hospital or other
- Collaborators
- Hasselt University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 5 Dec 2023 (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 study focuses on the impact of osteoarthritis (OA), a leading cause of disability among older adults, with the hip and knee joints being particularly affected. The rise in OA prevalence is attributed to factors such as aging and increasing obesity rates. Post-surgery rehabilitation, especially after total hip or knee replacement, traditionally relies on supervised clinical assessments, which have limitations in capturing real-world experiences. The study aims to explore the integration of technology-assisted rehabilitation, utilizing wearable sensors and mobile health technologies, for unsupervised, real-world assessments. The use of digital biomarkers collected from these technologies offers continuous, objective measurements of patients' biological and physiological data. The research employs a dataset from moveUP digital therapies, including patients who underwent total knee arthroplasty, utilizing a digital application for at least six weeks post-surgery.
Key objectives include evaluating the potential of automated unsupervised assessments in providing a holistic understanding of patient progression during rehabilitation. The study utilizes mixed models for statistical analysis, examining outcomes such as steps per day, 6-minute walk test, and peak 1 minute. Results indicate differences in recovery trajectories between hip and knee patients, with variations based on gender and type of prosthesis.
Detailed description
Data Source:
This retrospective observational study utilized anonymized and depersonalized data from the moveUP digital therapies database (moveUP solution, Brussels, Belgium). The database encompasses information from patients who underwent hip and knee arthroplasty across Belgium, France, and the Netherlands. A cohort of 1144 patients who underwent elective total knee arthroplasty was selected based on their use of the digital application for a minimum of 6 weeks post-surgery, with completion of preoperative patient-reported outcome measures. Written informed consent for the scientific use of anonymized data was obtained from each patient. Regulatory guidelines were adhered to, and no institutional review board (IRB) approval was required, given the use of anonymized patient-level data.
Recording Device and Outcomes:
All data collection occurred through the moveUP® application, a registered medical device operating on a smart virtual platform designed for digital monitoring. This platform comprises a patient-facing mobile application and a web-based dashboard utilized by care providers. Objective data, including the number of steps per day and steps per minute, were collected using a commercial activity tracker (Garmin Vivofit 4) worn 24/7 by patients throughout the rehabilitation period. Patient-reported outcomes, such as the Oxford Knee Score, Forgotten Joint Score (FJS), Hip Osteoarthritis Outcome score (KOOS), Knee Osteoarthritis Outcome score (KOOS), UCLA Activity Scale (UCLA), and the EuroQol 5-Dimension (EQ5D), were measured before surgery and at various intervals up to two years post-surgery through the app.
Statistical Analysis:
We analyzed outcomes using mixed models for both knee and hip patients, treating values from each day as repeated measures. The model incorporated fixed effects related to recovery, days after surgery, age, gender, and the interaction between recovery and days. Our analysis employed fixed effects for recovery, days after surgery, and their interaction, with baseline measures normalized for comparability. Time needed to differentiate between recovery statuses was computed along with associated 95% confidence intervals. Statistical analyses were conducted at a significance level of 0.05 using RStudio (version 2023.09.0) with R version 4.4.2 and the LME4 package for mixed effect models.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with knee replacement | – | Other: Unsupervised monitoringThe knee replacement patient cohort in this study consists of individuals who underwent Total Knee Arthroplasty (TKA) and utilized the moveUP digital application for at least six weeks post-surgery. The criteria include: Total Knee Arthroplasty (TKA): Individuals who had surgical intervention for total knee replacement. moveUP Digital Application Usage: Patients actively engaged with the moveUP digital therapies platform, using the associated application for rehabilitation. The application aids and monitors the recovery process. Post-Surgery Duration of Six Weeks: To be part of the study, patients in this cohort used the digital application for a minimum of six weeks after knee replacement surgery. This duration aims to evaluate the effectiveness of technology-assisted rehabilitation during the critical early recovery phase. |
| patients with hip replacement | – | Other: Unsupervised monitoringThe hip replacement cohort likely comprises individuals who had total hip arthroplasty. Similar to the knee replacement cohort, inclusion criteria may involve using the moveUP digital application for at least six post-surgery weeks. Characteristics include: Total Hip Arthroplasty (THA): Patients underwent surgical intervention for total hip replacement. moveUP Digital Application Usage: Cohort members actively engaged with the moveUP digital therapies platform, utilizing the associated app for post-surgery rehabilitation. Post-Surgery Duration of Six Weeks: To join the study, patients likely used the digital application for a minimum of six weeks post-hip replacement surgery. This period helps assess technology-assisted rehabilitation effectiveness during early recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with Osteoarthritis (OA): The study focuses on individuals affected by osteoarthritis, a common degenerative joint condition. * Age Group: * Underwent Hip or Knee Replacement Surgery: The population includes individuals who have undergone either total hip arthroplasty or total knee arthroplasty. * Geographical Distribution: The dataset used for the study is from moveUP digital therapies and includes patients from Belgium, France, and the Netherlands. Therefore, the study population is likely diverse, representing patients from these regions. * Technology-Engaged Individuals:The study population engaged with technology-assisted rehabilitation through the moveUP digital therapies platform. * Minimum Post-Surgery Duration: Patients engaged with the technology-assisted rehabilitation for a minimum of six weeks post-surgery, indicating a focus on the early stages of the recovery process.
Key inclusion criteria (5 listed)
- Persons with Hip or Knee Replacement surgery
- minimum 18 years of age
- Patient has emailadres
- use of application for at least 6 weeks postop
- completion of preoperative questionnaire
Key exclusion criteria (2 listed)
- Patient younger than 18 years of age
- no emailadres
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 |
|---|---|---|
| Unsupervised monitoringThis study introduces technology-assisted rehabilitation for patients post-total hip or knee arthroplasty, utilizing wearable sensors and mobile health tech. The intervention includes: Technology-Assisted Rehabilitation: Utilizing wearable sensors and mobile health technologies, the intervention promotes unsupervised, real-world assessments after total hip or knee replacement. It shifts from traditional supervised clinical assessments. The moveUP digital therapies platform, featuring a dedicated mobile app, acts as the primary interface for patients in rehabilitation. Digital Biomarkers: The intervention involves gathering digital biomarkers from wearable sensors and mobile health tech. These biomarkers offer continuous, objective measurements of patients' biological and physiological data. Examples include mobility and activity level data. | Other | patients with hip replacement, patients with knee replacement |
Primary outcome
steps per day
Time frame: pre and 6 weeks post surgery
This parameter represents the daily step count of patients. Monitoring steps per day is a common metric for assessing mobility and physical activity during rehabilitation.
6 minute walking test
Time frame: pre and 6 weeks post surgery
he 6-minute walk test is a standard measure of functional capacity and endurance. Patients are assessed on the distance they can walk in six minutes, providing valuable information about their cardiovascular and musculoskeletal function
Peak 1 Minute
Time frame: pre and 6 weeks post surgery
Refers to the walking performance measured during a one-minute interval
Intensity
Time frame: pre and 6 weeks post surgery
intensity of physical activity, specifically focusing on activities classified as moderate-to-vigorous. This parameter provides information about the intensity of patients' physical efforts during rehabilitation
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 5 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Osteoarthritis, Hip, run by PXL University College at 1 site in Belgium.
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 5 inclusion and 2 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
steps per day (time frame: pre and 6 weeks post surgery). The study lists 4 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 5 Dec 2023.