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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

Tracking Information
First Submitted Date  ICMJE August 14, 2020
First Posted Date  ICMJE November 16, 2020
Last Update Posted Date October 21, 2021
Actual Study Start Date  ICMJE May 14, 2019
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
  • 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
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Up to 1 year ]
    Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.
  • 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.
  • Strength testing [ Time Frame: 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 [ Time Frame: Up to 12 weeks ]
    Measured by handheld goniometer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence
Official Title  ICMJE Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Pathology
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Smart Physiotherapy Activity Recognition System (SPARS)
  • 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.
    Intervention: Device: Smart Physiotherapy Activity Recognition System (SPARS)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robin Richards, MD 416-480-5051 Robin.Richards@sunnybrook.ca
Contact: David Burns, MD d.burns@mail.utoronto.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04629417
Other Study ID Numbers  ICMJE SPARS2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robin Richards Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP