Incorporating Wearable Technology for Enhanced Rehabilitation Monitoring After Hip and Knee Replacement
NCT ID: NCT06157190
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1144 participants
OBSERVATIONAL
2020-09-01
2023-10-30
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Unsupervised monitoring
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.
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.
Unsupervised monitoring
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.
Interventions
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Unsupervised monitoring
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.
Eligibility Criteria
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Inclusion Criteria
* minimum 18 years of age
* Patient has emailadres
* use of application for at least 6 weeks postop
* completion of preoperative questionnaire
Exclusion Criteria
* no emailadres
18 Years
ALL
No
Sponsors
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Hasselt University
OTHER
PXL University College
OTHER
Responsible Party
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Locations
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Move Up
Brussels, Brussels Capital, Belgium
Countries
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Other Identifiers
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PXLuc
Identifier Type: -
Identifier Source: org_study_id