An interventional study of Digital intervention in Musculoskeletal Diseases, sponsored by Sword Health, SA. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by Sword Health, SA · Not applicable, Interventional, and Treatment
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.
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:
Collection and objective analysis of the collected data will allow:
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 48,774 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Sword Health, SA is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tailored digital programs for individuals working for organizations that enter into a commercial agreement with SWORD Health, which acts as a service provider.
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.
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.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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).
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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 - \[(patient's score of the subscale x 100)/(total score of the subscale)\]
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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 - \[(patient's score of the subscale x 100)/(total score of the subscale)\]
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Self-reported Pain
Change over time in clinical outcomes common to all conditions measured through a 0-10 Pain Numerical Rating Scale
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Self-reported Surgical Intent
Change over time in clinical outcomes common to all conditions measured through a 0-10 Surgical Intent Numerical Rating Scale
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Self-reported Medication
Change over time in clinical outcomes common to all conditions measured through self reported consumption of painkillers
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Anxiety
Change over time in clinical outcomes common to all conditions measured through the General Anxiety Disorder-7 (GAD7) scale.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Fear avoidance behaviour
Change over time in clinical outcomes common to all conditions measured through the Fear Avoidance Beliefs Questionnaire - Work \& Physical Activity (FABQ).
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Work Productivity and Absenteeism
Change over time in clinical outcomes common to all conditions measured through the Work Productivity and Activity Impairment Questionnaire (WPAI).
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
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.
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Completion rates
Change in patient interaction with medical device over time measured through average retention rates at 8/12 weeks
Time frame: Baseline, each four weeks after initiation of rehabilitation program, and periodical follow-up assessments (each 8 weeks) until 2 years after enrolment
Plan to share: Yes — Study protocol and study aggregate results (including anonymised individual patient data) will be made available
Supporting information: Study protocol, Sap
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sword Health, SA