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The purpose of this study is to create a research repository, comprised of data collected in the course of rehabilitation programs for musculoskeletal disorders (MSDs) using the medical device SWORD Phoenix®, to ascertain the acceptance, engagement and effectiveness of programs using this asynchronous tele-rehabilitation platform in the treatment of multiple MSDs.
The present study is a prospective observational cohort study, aiming at compiling and objectively analysing all clinical and kinematic data collected by SWORD Phoenix® in the course of the rehabilitation programs using the device.
The study is part of the post-marketing surveillance program, enabling further assessment of the safety and performance of the medical device, as well as the efficacy and scalability of clinical interventions directed to musculoskeletal disorders involving this medical device, while unveiling disease-specific human motion patterns that will inform the development of new diagnostic and treatment tools.
The data that will be collected in the scope of this registry includes:
1. data that is sourced from the subject, which will be collected by the physical therapist managing that subject;
2. data that is generated by the physical therapist through interaction with the web-based Portal (i.e. session composition in terms of exercises, sets, repetitions, usage or not of external resistance)
3. data that is generated by the subject through interaction with the app (i.e. pain and fatigue levels, satisfaction)
4. data that is generated automatically by the medical device (i.e. range of motion, compliance)
Collection and objective analysis of the collected data will allow:
1. Continuous monitoring of the safety of this medical device, under the post-marketing surveillance process;
2. Monitoring of user needs, engagement and satisfaction to guide further improvements;
3. Analysis of the effectiveness of rehabilitation programs using this medical device;
4. Correlation of results with patient's demographic and clinical profiles;
5. Compilation of patient cohorts to increase and disseminate knowledge on each disorder, its progression and response to physical therapy programs;
6. Explore the cost-efficiency of physical therapy programs involving SWORD Phoenix®
7. Development of novel intelligent tools to assist therapists with patient management;
Not yet recruiting
Sword Health, SA
Published on BioPortfolio: 2019-09-23T04:51:43-0400
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