Digital Home-based Rehabilitation for Musculoskeletal Disorders

NCT04092946 | Completed

• 1 other identifier: SH-SA-MSK-US
• Study Type: interventional
• Target: 48,774
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Diseases

Keywords

Home-based rehabilitation; Biofeedback; Telerehabilitation

Outcome Measures

Primary Outcomes (7)

• 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.

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

• 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.

  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

  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

• 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

• 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.

  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

• 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 - \[(patient's score of the subscale x 100)/(total score of the subscale)\]

  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)

• Self-reported 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 Surgical Intent

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

• Self-reported Medication

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

• Anxiety

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

• Depression

  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)

Patients with musculoskeletal disorders

EXPERIMENTAL

Tailored digital programs for individuals working for organizations that enter into a commercial agreement with SWORD Health, which acts as a service provider.

Device: Digital intervention

Interventions

Digital intervention DEVICE

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.

Patients with musculoskeletal disorders

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sword Health, SA: lead

Study Sites (1)

SWORD Health Technologies, Inc

New York, New York, 10001, United States

Location

Related Publications (8)

• 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.

  PMID: 39561359 DERIVED

• 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.

  PMID: 39470695 DERIVED

• 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.

  PMID: 39016261 DERIVED

• 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.

  PMID: 36735933 DERIVED

• 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.

  PMID: 36543719 DERIVED

• 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.

  PMID: 35954555 DERIVED

• 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.

  PMID: 35714099 DERIVED

• 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.

  PMID: 34983488 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Fernando D Correia, MD

  Centro Hospitalar e Universitário do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, prospective, interventional study

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 17, 2019
• Study Start: June 16, 2020
• Primary Completion: August 10, 2022
• Study Completion: February 10, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available upon study 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

US (1)