NCT04092946

Digital Home-based Rehabilitation for Musculoskeletal Disorders

Home-based Digital Program for Musculoskeletal Disorders: a Large-scale, Multi-disorder, Prospective, Single-arm, Interventional Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48,774 (actual)
• Sponsor: Sword Health, SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Musculoskeletal Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-16
• Primary completion: 2022-08-10
• Completion: 2023-02-10
• First posted: 2019-09-17
• Last updated: 2023-04-11

Locations

1 site across 1 country: United States