Clinical trial NCT04819022: SWORD Health Patient Registry
Official title: Digitally Assisted Rehabilitation Programs for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 10500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: These programs will cover patients suffering from musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which, irrespective of their duration (acute, post-acute or chronic), significantly impact their quality of life, to the extent they seek specialized care in direct relation to these disorders. The programs will also cover patients submitted to surgery for a given musculoskeletal condition, including, but not limited to, shoulder tendon repair, shoulder replacement, spinal surgery, hip or knee replacement, meniscal repair, knee ligament reconstruction, undergoing physical rehabilitation programs after surgery.

Brief 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.

Detailed description: 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. Assess the adoption, engagement and feasibility of digital care programs for musculoskeletal conditions and musculoskeletal health
2. Assess the results of digital care programs and compare the costs with the benefits obtained;
3. Correlate the results with patient's demographic and clinical profiles;
4. Examine the impact of mental health and the behavioral modification components of SWORD Health interventions on disease markers, comorbidities, and productivity;
5. Increase the knowledge on several musculoskeletal conditions, namely how they progress and respond to digital care programs;
6. 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

Eligibility criteria: Inclusion Criteria:

* Over 18 years old;
* Initiating a rehabilitation program using the medical device SWORD Phoenix®;
* Able to understand study procedures and willing to provide informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Timed-up-and-go test (TUG)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Constant-Murley Shoulder Outcome Score (CM)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Knee range of motion
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Secondary outcomes:
measure: Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Hip Disability and Osteoarthritis Outcome Score
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Fear avoidance behaviour
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Single leg stance test (SLS)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Self-reported Pain (NPRS)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Self-reported Pain (VAS)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Self-reported fatigue (VAS)
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Self-reported satisfaction
timeFrame: Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Compliance
timeFrame: Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: SWORD Health, S.A.
Study officials:
affiliation: SWORD Health, Inc
name: Fernando D Correia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Correia FD, Molinos M, Neves C, Janela D, Carvalho D, Luis S, Francisco GE, Lains J, Bento V. Digital Rehabilitation for Acute Ankle Sprains: Prospective Longitudinal Cohort Study. JMIR Rehabil Assist Technol. 2021 Sep 30;8(3):e31247. doi: 10.2196/31247.