Digital Home-based Rehabilitation for Musculoskeletal Disorders

Status Completed

Clinical 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Musculoskeletal Diseases

Clinical Trial Details

NCT number	NCT04092946
Study type	Interventional
Source	Sword Health, SA
Contact
Status	Completed
Phase	N/A
Start date	June 16, 2020
Completion date	February 10, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.