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Musculoskeletal DiseasesNCT04092946

Digital Home-based Rehabilitation for Musculoskeletal Disorders

A study testing Digital intervention in people with Musculoskeletal Diseases, run by Sword Health, SA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the acceptance, engagement and outcomes of a digital care program for acute and chronic musculoskeletal conditions affecting the shoulder, elbow, hip, knee, ankle and spine. 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?
Digital intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48,774 participants
Where
1 siteUnited States
Study dates
16 Jun 2020to 10 Feb 2023
Phase
Interventional
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

Who may be able to join

  • Over 18 years old
  • Suffering from acute (<12 weeks) or chronic (>12 weeks) pain in the neck, low back, shoulder, elbow, hip, knee, ankle or wrist;
  • Able to understand study procedures and willing to provide informed consent

Who cannot join

  • Cardiac or respiratory condition incompatible with at least 20 minutes of light to moderate exercise
  • Cancer diagnosis or receiving treatment for cancer
  • Unexplained weight loss in the last 6 months
  • Significant trauma in the area of pain in the last 3 months
  • Rapidly progressive loss of strength and/or numbness in the arms/legs in the last 2 weeks
  • Unexplained change in bowel or urinary function in the last 2 weeks
  • Other known health condition limiting participation in an exercise program involving at least 20 minutes of light to moderate exercise

Trial locations and contacts

1 site in 1 country.

United States1 site

  • SWORD Health Technologies, Inc

    New York, New York, 10001

Other trials in United States

About this study

Official title: Home-based Digital Program for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Single-arm, Interventional Study

The purpose of this study is to assess the acceptance, engagement and outcomes of a digital care program for acute and chronic musculoskeletal conditions affecting the shoulder, elbow, hip, knee, ankle and spine.

Read the detailed description

SWORD Health has developed a novel digital biofeedback system for home-based physical rehabilitation - SWORD Phoenix- which is an FDA-listed class I medical device. The company has previously conducted two pilot studies (NCT03047252; NCT03045549) comparing a digital rehabilitation program using this device against conventional face-to-face physical therapy. These studies have proven the feasibility, safety and effectiveness of this medical device on rehabilitation after total knee and hip arthroplasty.

SWORD Health is now seeking additional validation of its digital programs on acute and chronic MSK conditions, to assess the acceptance, engagement and outcomes of these clinical programs. This study will also unveil disease-specific human motion patterns that may be used to inform the development of new diagnostic and treatment tools.

Data to be collected on every individual undergoing our programs includes:

  1. data that is sourced from the subject through online assessment forms
  2. data that is sourced from the subject, collected by the physical therapist managing that subject (i.e. suggestions for improvement);
  3. 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)
  4. data generated by the patient through interaction with the mobile app (i.e. pain and fatigue levels, satisfaction)
  5. 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. Monitoring of user needs, engagement and satisfaction to guide further improvements;
  2. Analysis of the effectiveness of these digital care programs;
  3. Correlation of results with patient's demographic and clinical profiles;
  4. Compilation of patient cohorts to increase and disseminate knowledge on each disorder, its progression and response to physical therapy programs;
  5. Explore the cost-efficiency of these digital programs
  6. Development of novel intelligent tools to assist therapists with patient management.
Being tested
Digital intervention
Keywords
Home-based rehabilitation, Biofeedback, Telerehabilitation
Medical subject headings
Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital interventionDevice

    Individuals included will be offered a program based on three pillars: education, cognitive-behavioural therapy (CBT) and therapeutic exercise.

    The therapeutic exercise component will be delivered in the form of exercise sessions to be performed independently by the individual at home using SWORD Phoenix. These programs will have a duration of between 8 and 12 weeks, according to the condition, following pre-defined protocols. These protocols can be adapted to the needs, performance and progress of each individual by their assigned physical therapist. Individuals will be asked to perform at least 3 exercise sessions per week, in different days, but will not be excluded in case of lower adherence.

    In addition to the exercises, the individuals will also have access to educational articles written by the clinical team, as well as to a CBT program delivered through a combination of written articles and pre-recorded audio sessions.

Study groups in NCT04092946
Study groupRoleWhat they receive
Patients with musculoskeletal disordersExperimentalTailored digital programs for individuals working for organizations that enter into a commercial agreement with SWORD Health, which acts as a service provider.
Receives: Device: Digital intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion

    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

  2. Neck Disability Index

    Change in condition-specific clinical outcomes over time measured through the Neck Disability Index.

    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

  3. Oswestry Disability Index

    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

  4. 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

  5. Foot and Ankle Ability Measure

    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

  6. 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

  7. Knee Injury and Osteoarthritis Outcome Score

    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

Secondary outcomes (10)

  1. Self-reported Pain

    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

  2. Self-reported Surgical Intent

    Change over time in clinical outcomes common to all conditions measured through a 0-10 Surgical Intent 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

  3. Self-reported Medication

    Change over time in clinical outcomes common to all conditions measured through self reported consumption of painkillers

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

  4. Anxiety

    Change over time in clinical outcomes common to all conditions measured through the General Anxiety Disorder-7 (GAD7) scale.

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

  5. Depression

    Self-administered version of the PRIME-MD diagnostic instrument for common mental disorders, used to monitor the severity of depression and response to treatment. The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Validated for use in primary care.

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

  6. 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

  7. Work Productivity and Absenteeism

    Change over time in clinical outcomes common to all conditions measured through the Work Productivity and Activity Impairment Questionnaire (WPAI).

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

  8. Engagement levels

    Change in patient interaction with medical device over time measured through adherence levels. Patients are asked to perform daily therapeutic sessions, 5-7 days a week. Engagement is calculated weekly and averaged by the end of the therapeutic program.

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

  9. Satisfaction scores

    Change in patient interaction with medical device over time measured through Net Promoter Scores. Patients are asked to report their satisfaction level by answering the question: "On a scale from zero to ten, how much would you recommend the system to one of your friends or neighbours?", where 0=do not recommend at all and 10=highly recommend.

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

  10. Completion rates

    Change in patient interaction with medical device over time measured through average retention rates at 8/12 weeks

    Measured: Baseline, 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.

  1. First posted17 Sep 2019
  2. Study start16 Jun 2020
  3. Primary completion10 Aug 2022
  4. Study completion10 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, prospective, interventional study
Masking
None (open label)
Enrolment
48,774 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04092946
Sponsor's protocol ID
SH-SA-MSK-US
Status last verified
Apr 2023
First submitted
6 Sep 2019
Last updated
11 Apr 2023
Results posted
No
Data monitoring committee
No
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

  • C Areias A, G Moulder R, Molinos M, Janela D, Bento V, Moreira C, Yanamadala V, P Cohen S, Dias Correia F, Costa F. Predicting Pain Response to a Remote Musculoskeletal Care Program for Low Back Pain Management: Development of a Prediction Tool. JMIR Med Inform. 2024 Nov 19;12:e64806. doi: 10.2196/64806.

    PubMed 39561359

  • Areias AC, Janela D, Molinos M, Bento V, Moreira C, Yanamadala V, Cohen SP, Correia FD, Costa F. Exploring the Importance of Race and Gender Concordance Between Patients and Physical Therapists in Digital Rehabilitation for Musculoskeletal Conditions: Observational, Longitudinal Study. J Med Internet Res. 2024 Oct 29;26:e65354. doi: 10.2196/65354.

    PubMed 39470695

  • Janela D, Areias AC, Moulder RG, Molinos M, Bento V, Yanamadala V, Correia FD, Costa F. Recovering Work Productivity in a Population With Chronic Musculoskeletal Pain: Unveiling the Value and Cost-Savings of a Digital Care Program. J Occup Environ Med. 2024 Oct 1;66(10):e493-e499. doi: 10.1097/JOM.0000000000003191. Epub 2024 Jul 16.

    PubMed 39016261

  • Scheer J, Areias AC, Molinos M, Janela D, Moulder R, Lains J, Bento V, Yanamadala V, Dias Correia F, Costa F. Engagement and Utilization of a Complete Remote Digital Care Program for Musculoskeletal Pain Management in Urban and Rural Areas Across the United States: Longitudinal Cohort Study. JMIR Mhealth Uhealth. 2023 Mar 16;11:e44316. doi: 10.2196/44316.

    PubMed 36735933

  • Areias AC, Costa F, Janela D, Molinos M, Moulder RG, Lains J, Scheer JK, Bento V, Yanamadala V, Cohen SP, Correia FD. Impact on productivity impairment of a digital care program for chronic low back pain: A prospective longitudinal cohort study. Musculoskelet Sci Pract. 2023 Feb;63:102709. doi: 10.1016/j.msksp.2022.102709. Epub 2022 Dec 12.

    PubMed 36543719

  • Janela D, Costa F, Molinos M, Moulder RG, Lains J, Bento V, Scheer JK, Yanamadala V, Cohen SP, Correia FD. Digital Rehabilitation for Elbow Pain Musculoskeletal Conditions: A Prospective Longitudinal Cohort Study. Int J Environ Res Public Health. 2022 Jul 27;19(15):9198. doi: 10.3390/ijerph19159198.

    PubMed 35954555

  • Costa F, Janela D, Molinos M, Moulder R, Bento V, Lains J, Scheer J, Yanamadala V, Cohen S, Dias Correia F. Impacts of Digital Care Programs for Musculoskeletal Conditions on Depression and Work Productivity: Longitudinal Cohort Study. J Med Internet Res. 2022 Jul 25;24(7):e38942. doi: 10.2196/38942.

    PubMed 35714099

  • Costa F, Janela D, Molinos M, Lains J, Francisco GE, Bento V, Dias Correia F. Telerehabilitation of acute musculoskeletal multi-disorders: prospective, single-arm, interventional study. BMC Musculoskelet Disord. 2022 Jan 4;23(1):29. doi: 10.1186/s12891-021-04891-5.

    PubMed 34983488

Questions about this trial

What is this clinical trial studying?

A study testing Digital intervention in people with Musculoskeletal Diseases, run by Sword Health, SA at 1 site in United States.

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 7 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 11 Apr 2023. 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 United States. 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?

Neck, lower spine, shoulder, elbow, ankle, hip and 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). The study lists 7 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 NCT04092946, which also lists 8 linked publications.

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 11 Apr 2023.

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