Digital Home-based Rehabilitation for Musculoskeletal Disorders

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Diseases
• Intervention / Treatment: Device: Digital intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 48774
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • SWORD Health Technologies, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with musculoskeletal disorders; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Pain	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 Surgical Intent	Change over time in clinical outcomes common to all conditions measured through a 0-10 Surgical Intent 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 Medication	Change over time in clinical outcomes common to all conditions measured through self reported consumption of painkillers	Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Anxiety	Change over time in clinical outcomes common to all conditions measured through the General Anxiety Disorder-7 (GAD7) scale.	Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.	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
Work Productivity and Absenteeism	Change over time in clinical outcomes common to all conditions measured through the Work Productivity and Activity Impairment Questionnaire (WPAI).	Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.	Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.	Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Completion rates	Change in patient interaction with medical device over time measured through average retention rates at 8/12 weeks	Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment

Collaborators and Investigators

• Sponsor: Sword Health, SA
• Investigators: Principal Investigator: Fernando D Correia, MD, Centro Hospitalar e Universitário do Porto

Publications and helpful links

General Publications

• Li CH, Seak CJ, Chaou CH, Su TH, Gao SY, Chien CY, Ng CJ. Comparison of the diagnostic accuracy of monocyte distribution width and procalcitonin in sepsis cases in the emergency department: a prospective cohort study. BMC Infect Dis. 2022 Jan 4;22(1):26. doi: 10.1186/s12879-021-06999-4.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Telerehabilitation; Biofeedback; Home-based rehabilitation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: SH-SA-MSK-US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and study aggregate results (including anonymised individual patient data) will be made available
• IPD Sharing Time Frame: The data will become available upon study publication, for 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No