Clinical trial NCT04092946: Digital Home-based Rehabilitation for Musculoskeletal Disorders
Official title: Home-based Digital Program for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Single-arm, Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Home-based rehabilitation
Biofeedback
Telerehabilitation
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 48774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, prospective, interventional study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neck, lower spine, shoulder, elbow, ankle, hip and knee range of motion
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Neck Disability Index
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Oswestry Disability Index
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Short version of the Disabilities of the Arm, Shoulder and Hand questionnaire
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Foot and Ankle Ability Measure
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Hip Disability and Osteoarthritis Outcome Score
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Secondary outcomes:
measure: Self-reported Pain
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Self-reported Surgical Intent
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Self-reported Medication
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Anxiety
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Depression
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Fear avoidance behaviour
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Work Productivity and Absenteeism
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Engagement levels
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Satisfaction scores
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
measure: Completion rates
timeFrame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Other outcomes:
Locations:
city: New York
country: United States
facility: SWORD Health Technologies, Inc
state: New York
Study officials:
affiliation: Centro Hospitalar e Universitário do Porto
name: Fernando D Correia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janela D, Costa F, Molinos M, Moulder RG, Lains J, Scheer JK, Bento V, Yanamadala V, Cohen SP, Correia FD. Fear Avoidance Beliefs in Upper-Extremity Musculoskeletal Pain Conditions: Secondary Analysis of a Prospective Clinical Study on Digital Care Programs. Pain Med. 2023 Apr 3;24(4):451-460. doi: 10.1093/pm/pnac149.
citation: 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.
citation: 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.
citation: 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.