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

June 15, 2023 updated by: Sunnybrook Health Sciences Centre
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4Y 1H1
        • Sunnybrook Holland Orthopaedic & Arthritic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3-5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 year
Numeric Pain Rating Scale (NPRS)
Time Frame: Up to 1 year
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
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.
Up to 1 year
Strength testing
Time Frame: Up to 12 weeks
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
Time Frame: Up to 12 weeks
Measured by handheld goniometer
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Robin Richards, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2019

Primary Completion (Actual)

April 27, 2023

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SPARS2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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