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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.
The data that will be collected in the scope of this registry includes:
Collection and objective analysis of the collected data will allow:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Musculoskeletal disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute and post-acute | Device | These programs will cover patients suffering from acute or post-acute musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed-up-and-go test (TUG) | Change in condition-specific clinical outcomes over time measured through the TUG test. The TUG consists on the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. As a reference, patients treated with conventional physiotherapy 6 months after total knee replacement reported a TUG of 9.1 seconds. | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Foot and Ankle Ability Measure (FAAM) | Change in condition-specific clinical outcomes over time, measured through the Foot and Ankle Ability Measure (FAAM). FAAM is a self-report measure that assesses physical function of individuals with lower leg, foot, and ankle musculoskeletal disorders. Thus instrument included 2 subscales: 1) Activities of Daily Living (ADLs) with 21 items and 2) Sports with 8 items. For each subscale patients are asked to answer each question with a single response that most clearly describes their condition within past week. To calculate the score for either subscale, the total number of points are added, divided by the total number os possible points (ADLs-84; Sports-32) and then multiplied by 100. | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Constant-Murley Shoulder Outcome Score (CM) | Change in condition-specific clinical outcomes over time, measured through the CM score. The scale consists of:
| Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM) | Change in condition-specific clinical outcomes over time measured through Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM) (flexion/extension/abduction/rotation), in degrees, as directly retrieved from the angle measurement tool integrated within the medical device. | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fernando D Correia, MD | SWORD Health, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SWORD Health, S.A. | Porto | 4000-437 Porto | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34499038 | Derived | 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. |
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Study protocol and study aggregate results (including anonymised individual patient data) will be made available.
The data will become available upon studies publication, for 5 years.
Study protocol will be available through a direct link in this platform. The excel file with the aggregate results will be made available as supplementary information upon study publication
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019467 | Subacute Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Chronic | Device | These programs will cover patients suffering from chronic musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these disorders. |
|
| Post-surgical | Device | These programs will 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. |
|
| Oswestry Disability Index (ODI) | Change in condition-specific clinical outcomes over time measured through the Oswestry Disability Index (ODI). \ The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Knee range of motion | Change in meniscal repair or cruciate ligament reconstruction patients' clinical outcomes over time measured through knee range of motion (ROM) (flexion/extension/abduction/rotation), in degrees, as directly retrieved from the angle measurement tool integrated within the medical device. | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire | Change in condition-specific clinical outcomes over time measured through the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH). Scoring Formula = ([(sum of n responses)/n] -1)x(25). | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Change in condition-specific clinical outcomes over time measured through the Knee Injury and Osteoarthritis Outcome Score (KOOS) Scoring Formula: 100 - [(patient's score of the subscale x 100)/(total score of the subscale)] | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Hip Disability and Osteoarthritis Outcome Score | Change in condition-specific clinical outcomes over time measured through the hip disability and osteoarthritis outcome score (HOOS) Scoring Formula: 100 - [(patient's score of the subscale x 100)/(total score of the subscale)] | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Fear avoidance behaviour | Change over time in clinical outcomes common to all conditions measured through the Fear Avoidance Beliefs Questionnaire - Work & Physical Activity (FABQ). | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Single leg stance test (SLS) | Change in condition-specific clinical outcomes over time measured through the SLS test. Used to assess static postural and balance control. Performed with eyes open and hands on the hips. Patient must stand unassisted on one leg, timed from the time the other foot leaves the ground till when the foot touches the ground again or the arms leave the hips. If unable to stand for 5 seconds or less client at greater risk of injury from fall. | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Self-reported Pain (NPRS) | Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Self-reported Pain (VAS) | Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for pain | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Self-reported fatigue (VAS) | Change over time in clinical outcomes common to all conditions measured through a 0-10 Visual Analogue Scale for fatigue | Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Self-reported satisfaction | Self-reported at the end of the program through the question: "On a scale from 0 to 10, how likely is it that you would recommend this intervention to a friend or neighbour?" | Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |
| Compliance | Average number os sessions performed per week | Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment |