Clinical trial NCT04629417: Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence
Official title: Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rotator Cuff Pathology
Keywords: Rehabilitation
Artificial Intelligence
Wearable Electronic Devices
Adherence
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An important part of recovery for shoulder injuries, is sticking to the exercise regimen that is prescribed by a physiotherapist. Currently, there is no proper way to measure whether patients are correcting doing their prescribed exercises at home. Researchers at Sunnybrook have tested out a Smart Physiotherapy Recognition System (SPARS), which consists of a watch that patients can wear while they are performing their physiotherapy exercises. The watch aims to learn how the exercises are done correctly when worn during supervised physiotherapy sessions, and then to record and compare whether those same exercises are being done correctly in a home setting. The main objectives of this study aims to test whether the SPARS system can effectively measure whether physiotherapy exercises are being done properly when they are done without physiotherapist supervision. Secondly, to examine whether the recovery process after shoulder injuries is improved if patients perform the physiotherapy exercises correctly.

Detailed description: A research assistant will conduct in-person data collection on 120 patients, by recording patients' exercises during their supervised physiotherapy sessions each week using the SPARS smart watch. Each patient will wear 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. 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. The patient population that is being funded by OHIP, will be recruited from referrals Sunnybrook Shoulder and Upper Extremity Program. Data collection will be collected at baseline (at time of informed consent), and at each supervised physiotherapy session during the course of a patient's treatment. A research assistant will be required to attend a minimum of one supervised physiotherapy session for each patient every two weeks, and record exercise type and technique, alongside the inertial data collection, based on feedback from the treating physiotherapist. 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.

Eligibility criteria: Inclusion Criteria:

1. Males and females over the age of 18
2. Be diagnosed with rotator cuff tendinosis, shoulder impingement syndrome or a rotator cuff tear
3. Will be undergoing planned conservative management
4. Be able to participate in home physiotherapy exercises

Exclusion Criteria:

1. Upper extremity neurological deficit
2. Have had a previous failed surgery on the shoulder that is currently being treated
3. Undergoing simultaneous treatment for both shoulders

Primary outcomes:
measure: Physiotherapy participation (smart watch inertial data)
timeFrame: Up to 3-5 months
Secondary outcomes:
measure: Work status
timeFrame: Up to 1 year
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Up to 1 year
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: Up to 1 year
measure: Strength testing
timeFrame: Up to 12 weeks
measure: Shoulder active range of motion
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Holland Orthopaedic & Arthritic Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Robin Richards
role: PRINCIPAL_INVESTIGATOR
References:
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