Incorporating Wearable Technology for Enhanced Rehabilitation Monitoring After Hip and Knee Replacement

NCT06157190 | Completed

• 1 other identifier: PXLuc
• Study Type: observational
• Target: 1,144
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis; Osteoarthritis, Hip

Keywords

wearable technology; rehabilitation monitoring

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  pre and 6 weeks post surgery

• Peak 1 Minute

  Refers to the walking performance measured during a one-minute interval

  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

  pre and 6 weeks post surgery

Study Arms (2)

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.

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.

Other: Unsupervised monitoring

Interventions

Unsupervised monitoring OTHER

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; patients with knee replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Patient younger than 18 years of age
• no emailadres

Sponsors & Collaborators

• PXL University College: lead
• Hasselt University: collaborator

Study Sites (1)

Move Up

Brussels, Brussels Capital, 1000, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: September 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

BE (1)