Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence

Not Applicable

Active, not recruiting

• Conditions: Rotator Cuff Pathology
• Interventions: Device: Smart Physiotherapy Activity Recognition System (SPARS)

• Registration Number: NCT04629417
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study Start: 2019-05-14
• Study First Submitted: 2020-08-14
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Primary Completion: 2023-04-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OHIP (funded) Patient Population	Smart Physiotherapy Activity Recognition System (SPARS)	Participants that have a confirmed rotator cuff pathology, and are undergoing physiotherapy at the Holland Centre as part of the Shoulder Program.
Injured Worker Population	Smart Physiotherapy Activity Recognition System (SPARS)	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.

Primary Outcome Measures

Name	Time	Method
Physiotherapy participation (smart watch inertial data)	Up to 3-5 months	Watch will begin recording inertial sensor data when it is put on during supervised and home physiotherapy exercises, and will stop recording when it is removed.

Secondary Outcome Measures

Name	Time	Method
The Disabilities of the Arm, Shoulder and Hand (DASH) Score	Up to 1 year	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.
Strength testing	Up to 12 weeks	Rotator cuff strength testing using manual muscle testing as well as strength testing with a dynamometer
Shoulder active range of motion	Up to 12 weeks	Measured by handheld goniometer
Work status	Up to 1 year	Clinical and return to work outcome data Full-time, part-time, off-work, modified or regular duties
Numeric Pain Rating Scale (NPRS)	Up to 1 year	Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.

Trial Locations

Locations (1)

Sunnybrook Holland Orthopaedic & Arthritic Centre; 🇨🇦 Toronto, Ontario, Canada