Musculoskeletal DiseasesNCT04819022
SWORD Health Patient Registry
An observational study of Musculoskeletal Diseases, run by Sword Health, SA at 1 site in Portugal.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Acute and post-acute, Chronic and Post-surgical
- Type of treatment
- Medical device
- How many people
- 10,500 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2019to 1 Jan 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digitally Assisted Rehabilitation Programs for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Longitudinal Cohort Study
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.
Read the detailed 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
- Conditions
- Musculoskeletal Diseases
- Being tested
- Acute and post-acute, Chronic, Post-surgical
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute and post-acuteDevice
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.
ChronicDevice
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-surgicalDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal disorder | Not described Receives: Device: Acute and post-acute; Device: Chronic; Device: Post-surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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:
- Subjective variables: a) Pain - Absence of pain gets maximum score of 15; b) Limitation of Activities of daily living (sleep, work, recreation/sport). No limitations get maximum score, 20. The subjective variables add to a maximum score of 35.
- Objective variables: c) Range of motion - Maximum score 40; d) Strength - Maximum Score 25 Objective variables add to a total of 65. Total Constant Score is calculated by adding the scores from subjective and objective variables. The maximum possible total score is 100.
Measured: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Measured: 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.
Measured: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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)]
Measured: 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)]
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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?"
Measured: 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
Measured: Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sword Health, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando D Correia, MD, Principal investigator, SWORD Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819022
- Sponsor's protocol ID
- SH-MSD-OBS-01
- Status last verified
- Dec 2024
- First submitted
- 23 Mar 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and study aggregate results (including anonymised individual patient data) will be made available.
Publications
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.
PubMed 34499038
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Assisted Rehabilitation Programs for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT04819022
- Acronym / sponsor ID
- SH-MSD-OBS-01
- Conditions
- Musculoskeletal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,500 participants (actual)
- Lead sponsor
- Sword Health, SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal disorder | – | Device: Acute and post-acute, Device: Chronic, Device: Post-surgical |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute and post-acuteThese 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. | Device | Musculoskeletal disorder |
| ChronicThese 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. | Device | Musculoskeletal disorder |
| Post-surgicalThese 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. | Device | Musculoskeletal disorder |
Primary outcome
Timed-up-and-go test (TUG)
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Foot and Ankle Ability Measure (FAAM)
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Constant-Murley Shoulder Outcome Score (CM)
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Change in condition-specific clinical outcomes over time, measured through the CM score. The scale consists of: 1. Subjective variables: a) Pain - Absence of pain gets maximum score of 15; b) Limitation of Activities of daily living (sleep, work, recreation/sport). No limitations get maximum score, 20. The subjective variables add to a maximum score of 35. 2. Objective variables: c) Range of motion - Maximum score 40; d) Strength - Maximum Score 25 Objective variables add to a total of 65. Total Constant Score is calculated by adding the scores from subjective and objective variables. The maximum possible total score is 100.
Oswestry Disability Index (ODI)
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Knee range of motion
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
11 secondary outcomes
Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Compliance
Time frame: Each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 34499038Correia 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.
- Individual participant dataSharing planned: Yes. Study protocol and study aggregate results (including anonymised individual patient data) will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando D Correia, MD principal investigator
SWORD Health, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases, run by Sword Health, SA at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed-up-and-go test (TUG) (time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.