Rotator Cuff PathologySPARSNCT04629417
Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence
A study testing Smart Physiotherapy Activity Recognition System (SPARS) in people with Rotator Cuff Pathology, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Pathology
- What is being tested?
- Smart Physiotherapy Activity Recognition System (SPARS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- 14 May 2019to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females over the age of 18
- Be diagnosed with rotator cuff tendinosis, shoulder impingement syndrome or a rotator cuff tear
- Will be undergoing planned conservative management
- Be able to participate in home physiotherapy exercises
Who cannot join
- Upper extremity neurological deficit
- Have had a previous failed surgery on the shoulder that is currently being treated
- Undergoing simultaneous treatment for both shoulders
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Holland Orthopaedic & Arthritic Centre
Toronto, Ontario, M4Y 1H1
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Pathology
- Being tested
- Smart Physiotherapy Activity Recognition System (SPARS)
- Keywords
- Rehabilitation, Artificial Intelligence, Wearable Electronic Devices, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Physiotherapy Activity Recognition System (SPARS)Device
Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) while patients are performing physiotherapy exercises.
| Study group | Role | What they receive |
|---|---|---|
| Injured Worker Population | Experimental | 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. Receives: Device: Smart Physiotherapy Activity Recognition System (SPARS) |
| OHIP (funded) Patient Population | Active comparator | Participants that have a confirmed rotator cuff pathology, and are undergoing physiotherapy at the Holland Centre as part of the Shoulder Program. Receives: Device: Smart Physiotherapy Activity Recognition System (SPARS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiotherapy participation (smart watch inertial data)
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.
Measured: Up to 3-5 months
Secondary outcomes (5)
Work status
Clinical and return to work outcome data Full-time, part-time, off-work, modified or regular duties
Measured: Up to 1 year
Numeric Pain Rating Scale (NPRS)
Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.
Measured: Up to 1 year
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
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.
Measured: Up to 1 year
Strength testing
Rotator cuff strength testing using manual muscle testing as well as strength testing with a dynamometer
Measured: Up to 12 weeks
Shoulder active range of motion
Measured by handheld goniometer
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start14 May 2019
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Richards, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629417
- Sponsor's protocol ID
- SPARS2019
- Acronym
- SPARS
- Status last verified
- Jul 2024
- First submitted
- 14 Aug 2020
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Littlewood C, Bateman M, Clark D, Selfe J, Watkinson D, Walton M, Funk L. Rehabilitation following rotator cuff repair: a systematic review. Shoulder Elbow. 2015 Apr;7(2):115-24. doi: 10.1177/1758573214567702. Epub 2015 Jan 29.
PubMed 27582966Thomson S, Jukes C, Lewis J. Rehabilitation following surgical repair of the rotator cuff: a systematic review. Physiotherapy. 2016 Mar;102(1):20-8. doi: 10.1016/j.physio.2015.08.003. Epub 2015 Sep 8.
PubMed 26510584Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.
PubMed 20163979Faber M, Andersen MH, Sevel C, Thorborg K, Bandholm T, Rathleff M. The majority are not performing home-exercises correctly two weeks after their initial instruction-an assessor-blinded study. PeerJ. 2015 Jul 21;3:e1102. doi: 10.7717/peerj.1102. eCollection 2015.
PubMed 26244112Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA. A systematic review of measures of self-reported adherence to unsupervised home-based rehabilitation exercise programmes, and their psychometric properties. BMJ Open. 2014 Jun 27;4(6):e005044. doi: 10.1136/bmjopen-2014-005044.
PubMed 24972606Burns DM, Leung N, Hardisty M, Whyne CM, Henry P, McLachlin S. Shoulder physiotherapy exercise recognition: machine learning the inertial signals from a smartwatch. Physiol Meas. 2018 Jul 23;39(7):075007. doi: 10.1088/1361-6579/aacfd9.
PubMed 29952759Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
PubMed 11382253Staples MP, Forbes A, Green S, Buchbinder R. Shoulder-specific disability measures showed acceptable construct validity and responsiveness. J Clin Epidemiol. 2010 Feb;63(2):163-70. doi: 10.1016/j.jclinepi.2009.03.023. Epub 2009 Aug 14.
PubMed 19683414
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence
- ClinicalTrials.gov ID
- NCT04629417
- Acronym / sponsor ID
- SPARS / SPARS2019
- Conditions
- Rotator Cuff Pathology
- Keywords
- Rehabilitation, Artificial Intelligence, Wearable Electronic Devices, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured Worker Population | Experimental | Device: 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. |
| OHIP (funded) Patient Population | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females over the age of 18
- Be diagnosed with rotator cuff tendinosis, shoulder impingement syndrome or a rotator cuff tear
- Will be undergoing planned conservative management
- Be able to participate in home physiotherapy exercises
Key exclusion criteria (3 listed)
- Upper extremity neurological deficit
- Have had a previous failed surgery on the shoulder that is currently being treated
- Undergoing simultaneous treatment for both shoulders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Physiotherapy Activity Recognition System (SPARS)Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) while patients are performing physiotherapy exercises. | Device | Injured Worker Population, OHIP (funded) Patient Population |
Primary outcome
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.
5 secondary outcomes
Work status
Time frame: Up to 1 year
Numeric Pain Rating Scale (NPRS)
Time frame: Up to 1 year
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: Up to 1 year
Strength testing
Time frame: Up to 12 weeks
Shoulder active range of motion
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Background: PubMed 27582966Littlewood C, Bateman M, Clark D, Selfe J, Watkinson D, Walton M, Funk L. Rehabilitation following rotator cuff repair: a systematic review. Shoulder Elbow. 2015 Apr;7(2):115-24. doi: 10.1177/1758573214567702. Epub 2015 Jan 29.
- Background: PubMed 26510584Thomson S, Jukes C, Lewis J. Rehabilitation following surgical repair of the rotator cuff: a systematic review. Physiotherapy. 2016 Mar;102(1):20-8. doi: 10.1016/j.physio.2015.08.003. Epub 2015 Sep 8.
- Background: PubMed 20163979Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.
- Background: PubMed 26244112Faber M, Andersen MH, Sevel C, Thorborg K, Bandholm T, Rathleff M. The majority are not performing home-exercises correctly two weeks after their initial instruction-an assessor-blinded study. PeerJ. 2015 Jul 21;3:e1102. doi: 10.7717/peerj.1102. eCollection 2015.
- Background: PubMed 24972606Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA. A systematic review of measures of self-reported adherence to unsupervised home-based rehabilitation exercise programmes, and their psychometric properties. BMJ Open. 2014 Jun 27;4(6):e005044. doi: 10.1136/bmjopen-2014-005044.
- Background: PubMed 29952759Burns DM, Leung N, Hardisty M, Whyne CM, Henry P, McLachlin S. Shoulder physiotherapy exercise recognition: machine learning the inertial signals from a smartwatch. Physiol Meas. 2018 Jul 23;39(7):075007. doi: 10.1088/1361-6579/aacfd9.
- Background: PubMed 11382253Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
- Background: PubMed 19683414Staples MP, Forbes A, Green S, Buchbinder R. Shoulder-specific disability measures showed acceptable construct validity and responsiveness. J Clin Epidemiol. 2010 Feb;63(2):163-70. doi: 10.1016/j.jclinepi.2009.03.023. Epub 2009 Aug 14.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Richards principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Physiotherapy Activity Recognition System (SPARS) in people with Rotator Cuff Pathology, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiotherapy participation (smart watch inertial data) (time frame: Up to 3-5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629417, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.