Digital Home-based Rehabilitation for Musculoskeletal Disorders

SWORD Health

Status: Completed

Conditions: Musculoskeletal Diseases

Treatments: Device: Digital intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT04092946

SH-SA-MSK-US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48,774 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48,774 participants in 1 patient group

Patients with musculoskeletal disorders

Experimental group

Description:

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

Treatment:

Device: Digital intervention