Digital Home-based Rehabilitation for Musculoskeletal Disorders

Musculoskeletal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092946
• Other study ID #: SH-SA-MSK-US
• Status: Completed
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: April 2023
• Source: Sword Health, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48774
• Est. completion date: February 10, 2023
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	SWORD Health Technologies, Inc	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sword Health, SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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