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Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence (SPARS)

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ClinicalTrials.gov Identifier: NCT04629417
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Pathology Device: Smart Physiotherapy Activity Recognition System (SPARS) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Injured Worker Population
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)
Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) while patients are performing physiotherapy exercises.
Active Comparator: OHIP (funded) Patient Population
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)
Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) while patients are performing physiotherapy exercises.


Outcome Measures
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Primary Outcome Measures :
  1. Physiotherapy participation (smart watch inertial data) [ Time Frame: 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 :
  1. Work status [ Time Frame: Up to 1 year ]
    Clinical and return to work outcome data Full-time, part-time, off-work, modified or regular duties

  2. Numeric Pain Rating Scale (NPRS) [ Time Frame: Up to 1 year ]
    Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.

  3. The Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 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.

  4. Strength testing [ Time Frame: Up to 12 weeks ]
    Rotator cuff strength testing using manual muscle testing as well as strength testing with a dynamometer

  5. Shoulder active range of motion [ Time Frame: Up to 12 weeks ]
    Measured by handheld goniometer


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629417


Contacts
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Contact: Robin Richards, MD 416-480-5051 Robin.Richards@sunnybrook.ca
Contact: David Burns, MD d.burns@mail.utoronto.ca

Locations
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Canada, Ontario
Sunnybrook Holland Orthopaedic & Arthritic Centre Recruiting
Toronto, Ontario, Canada, M4Y 1H1
Contact: Robin Richards, MD    416-480-5051    robin.richards@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Robin Richards Sunnybrook Health Sciences Centre
More Information
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Publications:

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04629417    
Other Study ID Numbers: SPARS2019
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Rehabilitation
Artificial Intelligence
Wearable Electronic Devices
Adherence