SWORD Health Patient Registry
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- STATUS
- Recruiting
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- End date
- Jan 15, 2024
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- participants needed
- 10000
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- sponsor
- Sword Health, SA
Summary
The purpose of this study is to create a research repository, comprised of data collected in the course of physical rehabilitation programs for musculoskeletal disorders (MSDs) using the medical device SWORD Phoenix®.
This will allow the company to ascertain the acceptance, engagement and effectiveness of programs using this asynchronous tele-rehabilitation platform in the treatment of multiple MSDs.
Description
The data that will be collected in the scope of this registry includes:
- data that is sourced from the subject, which will be collected by the physical therapist managing that subject;
- 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)
- data that is generated by the subject through interaction with the app (i.e. pain and fatigue levels, satisfaction)
- 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:
- Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health
- Assess the results of digital care programs and compare the costs with the benefits obtained;
- Correlate the results with patient's demographic and clinical profiles;
- Examine the impact of mental health and the behavioral modification components of SWORD Health interventions on disease markers, comorbidities, and productivity;
- Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
- Develop new or improved tools to assist clinicians in the management of these conditions and in helping people achieve better musculoskeletal health
Clinical outcomes
The primary outcome will be the evolution of patient's clinical condition along the rehabilitation program, objectively estimated through the monitoring data collected using SWORD Phoenix®, as part of patients' supervision routine. Depending on the condition, primary and secondary outcome measures vary.
In any case, this registry will include a complete characterisation of the clinical condition, as well as the periodic assessment of: a) joints' range of motion (collect by the medical device); b) performance indicators (through condition-specific tests); c) patient-reported outcomes (obtained using internationally validated pathology-specific questionnaires); d) pain and fatigue levels (reported by patients by the end of each therapeutic exercise session); e) compliance; f) patient satisfaction
Details
| Condition | Musculoskeletal Diseases |
|---|---|
| Treatment | Acute and post-acute, Chronic, Chronic, Post-surgical, Post-surgical |
| Clinical Study Identifier | NCT04819022 |
| Sponsor | Sword Health, SA |
| Last Modified on | 15 June 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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