SWORD Health Patient Registry

NCT04819022 | Completed DMC

• 1 other identifier: SH-MSD-OBS-01
• Study Type: observational
• Target: 10,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (5)

• 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: 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.

  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.

  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

Secondary Outcomes (11)

• Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion (ROM)

  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

  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)

  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

  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

  Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment

Study Arms (1)

Musculoskeletal disorder

Device: Acute and post-acute; Device: Chronic; Device: Post-surgical

Interventions

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.

Musculoskeletal disorder

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.

Musculoskeletal disorder

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.

Musculoskeletal disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Sword Health, SA: lead

Study Sites (1)

SWORD Health, S.A.

Porto, 4000-437 Porto, Portugal

Location

Related Publications (1)

• 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.

  PMID: 34499038 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Subacute Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fernando D Correia, MD

  SWORD Health, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available upon studies publication, for 5 years.
• Access Criteria: 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

Locations

PT (1)