Novel Shoulder Rehabilitation Program (SPARS-REHAB)

Study Overview
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Brief Summary
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Physical therapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their physiotherapy independently at home. It is unknown how often patients perform their home exercises, if these exercises are done correctly without supervision, and how poor adherence might impact recovery. The investigators have recently developed a Smart Physiotherapy Activity Recognition System (SPARS) for tracking home shoulder physiotherapy exercises using sensors in a commercial smart watch and artificial intelligence (AI). SPARS was successful in identifying shoulder exercises in healthy adults in the laboratory setting, and in patients undergoing physiotherapy for rotator cuff pathology. Further inquiry is required to establish the clinical effectiveness of this technology for tracking and improving patient engagement, and to investigate the potential individual impacts of its use.

Detailed Description
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The Research Team will conduct in-person data collection on 30 patients, by recording patients' exercises during their supervised physiotherapy sessions each week using the SPARS smart watch. Each patient will wear the smart watch on their affected arm only when performing prescribed exercises, and the watch will start recording inertial sensor data once the patient puts the watch on and the exercise is started on the tablet. An app installed on the provided Android smart tablet allows the patient to view their assigned exercises, videos showing them how to perform those exercises, and the record of their tracked participation. A tablet app will also be available to the treating physiotherapist to allow them to view this same data. The purpose of the participation tracking is to promote better patient engagement in the home component of physiotherapy. The injured worker population will be recruited from referrals made to the Sunnybrook Working Condition Program (WCP) at the Holland Centre for a work-related shoulder injury. Physical therapy of the patient population will be recruited from referrals by the Sunnybrook Shoulder and Upper Extremity Program funded by study grants. Data collection will be collected at each supervised physiotherapy session during the course of a patient's treatment. Follow-up outcomes such as surveys and shoulder testing will be done at 6 weeks, monthly at a maximum of 3 months (OHIP-patients) and 5 months (WSIB) patients, final treatment session (if different than maximum amount), and 1 year after.

Official Title
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User Centred Design and Pilot Testing of a Novel Shoulder Rehabilitation Program With Engagement Tracking

Conditions
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Rotator Cuff Pathology

Intervention / Treatment
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* Device: Smart Physiotherapy Activity Recognition System (SPARS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females over the age of 18 Diagnosed with rotator cuff tendinosis, shoulder impingement syndrome, or degenerative or traumatic rotator cuff tear Planned conservative (non-operative) management Capacity to participate in home shoulder physiotherapy Exclusion Criteria: Upper extremity neurologic deficit Symptomatic contralateral shoulder with limited mobility requiring treatment Failed surgical management of rotator cuff pathology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Device: Smart Physiotherapy Activity Recognition System (SPARS)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Injured Worker Population<br>Participants that have a confirmed rotator cuff pathology, and are undergoing physiotherapy at the Holland Centre for a work-related shoulder injury as part of the Working Condition Program. | Device: Smart Physiotherapy Activity Recognition System (SPARS)<br>* Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) and the exercise is started on the tablet, while patients are performing physiotherapy exercises.<br>|
| Active Comparator: Active Comparator: OHIP (funded) Patient Population<br>Participants that have a confirmed rotator cuff pathology, and are undergoing physiotherapy at the Holland Centre as part of the Shoulder Program. | Device: Smart Physiotherapy Activity Recognition System (SPARS)<br>* Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) and the exercise is started on the tablet, while patients are performing physiotherapy exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiotherapy participation (Minutes weekly physiotherapy) | Investigators will recruit up to 30 patients with rotator cuff pathology. Watch will begin recording inertial sensor data when it is put on by a patient during supervised and home physiotherapy exercises and the exercise is started on the tablet, and will stop recording when it is removed and the exercise is stopped on the tablet. Inertial data will be analyzed to generate quantitative measures of at-home physiotherapy participation in comparison to each patient's current physiotherapy prescription. Participation will be measured in minutes of weekly physiotherapy participation. Participation measurement will be compared to historical controls to detect statistically significant differences resulting from the use of apps by patients and their physiotherapists. | Up to 3-5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work status | Clinical and return to work outcome data full-time, part-time, off-work, modified or regular duties. | Up to 1 year | 
| Numeric Pain Rating Scale (NPRS) | Scale range: 0 to 10 (whole number integers). Higher scores represent more pain. | Up to 1 year | 
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | Self administered questionnaire to self rate upper extremity disability and symptoms. Comprises of a 30-item disability/symptom scale, and higher scores represent more symptoms/disability. | Up to 1 year | 
| The American Shoulder and Elbow Society (ASES) Score | Self administered questionnaire to self rate current shoulder pain and the ability to do 10 activities, and lower scores represent more inability to perform these activities. | Up to 1 year | 
| Strength testing | Rotator cuff strength testing using manual muscle testing as well as strength testing with a dynamometer. | Up to 12 weeks | 
| Shoulder active range of motion | Measured by a handheld goniometer | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Artificial Intelligence, Wearable Electronic Devices, Adherence, Physiotherapy, Rotator Cuff Pathology