Rotator Cuff PathologySPARS-REHABNCT05139173
Novel Shoulder Rehabilitation Program (SPARS-REHAB)
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
Physical therapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their… 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
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jan 2022to 8 Oct 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
- Diagnosed with rotator cuff tendinosis, shoulder impingement syndrome, or degenerative or traumatic rotator cuff tear
- Planned conservative (non-operative) management
- Capacity to participate in home shoulder physiotherapy
Who cannot join
- Upper extremity neurologic deficit
- Symptomatic contralateral shoulder with limited mobility requiring treatment
- Failed surgical management of rotator cuff pathology
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Holland Orthopaedic & Arthritic Centre
Toronto, Ontario, M4Y 1H1
About this study
Official title: User Centred Design and Pilot Testing of a Novel Shoulder Rehabilitation Program With Engagement Tracking
Physical therapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their physiotherapy independently at home. It is unknown how often patients perform their home exercises, if these exercises are done correctly without supervision, and how poor adherence might impact recovery.
The investigators have recently developed a Smart Physiotherapy Activity Recognition System (SPARS) for tracking home shoulder physiotherapy exercises using sensors in a commercial smart watch and artificial intelligence (AI). SPARS was successful in identifying shoulder exercises in healthy adults in the laboratory setting, and in patients undergoing physiotherapy for rotator cuff pathology. Further inquiry is required to establish the clinical effectiveness of this technology for tracking and improving patient engagement, and to investigate the potential individual impacts of its use.
Read the detailed description
The Research Team will conduct in-person data collection on 30 patients, by recording patients' exercises during their supervised physiotherapy sessions each week using the SPARS smart watch. Each patient will wear the 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 and the exercise is started on the tablet. An app installed on the provided Android smart tablet allows the patient to view their assigned exercises, videos showing them how to perform those exercises, and the record of their tracked participation. A tablet app will also be available to the treating physiotherapist to allow them to view this same data. The purpose of the participation tracking is to promote better patient engagement in the home component of physiotherapy.
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. Physical therapy of the patient population will be recruited from referrals by the Sunnybrook Shoulder and Upper Extremity Program funded by study grants. Data collection will be collected at each supervised physiotherapy session during the course of a patient's treatment. 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, Physiotherapy, Rotator Cuff Pathology
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) and the exercise is started on the tablet, while patients are performing physiotherapy exercises.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 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) |
| Active Comparator: 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 (Minutes weekly physiotherapy)
Investigators will recruit up to 30 patients with rotator cuff pathology. Watch will begin recording inertial sensor data when it is put on by a patient during supervised and home physiotherapy exercises and the exercise is started on the tablet, and will stop recording when it is removed and the exercise is stopped on the tablet. Inertial data will be analyzed to generate quantitative measures of at-home physiotherapy participation in comparison to each patient's current physiotherapy prescription. Participation will be measured in minutes of weekly physiotherapy participation. Participation measurement will be compared to historical controls to detect statistically significant differences resulting from the use of apps by patients and their physiotherapists.
Measured: Up to 3-5 months
Secondary outcomes (6)
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
The American Shoulder and Elbow Society (ASES) Score
Self administered questionnaire to self rate current shoulder pain and the ability to do 10 activities, and lower scores represent more inability to perform these activities.
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 a 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 posted1 Dec 2021
- Study start17 Jan 2022
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Device: Smart Physiotherapy Activity Recognition System (SPARS)
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Helen Razmjou, Principal investigator, Sunnybrook Holland Orthopaedic & Arthritic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139173
- Sponsor's protocol ID
- SPARS-REHAB
- Acronym
- SPARS-REHAB
- Status last verified
- Jul 2024
- First submitted
- 15 Nov 2021
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Centred Design and Pilot Testing of a Novel Shoulder Rehabilitation Program With Engagement Tracking
- ClinicalTrials.gov ID
- NCT05139173
- Acronym / sponsor ID
- SPARS-REHAB / SPARS-REHAB
- Conditions
- Rotator Cuff Pathology
- Keywords
- Rehabilitation, Artificial Intelligence, Wearable Electronic Devices, Adherence, Physiotherapy, Rotator Cuff Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 1 Dec 2021 (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.
Physical therapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their physiotherapy independently at home. It is unknown how often patients perform their home exercises, if these exercises are done correctly without supervision, and how poor adherence might impact recovery.
The investigators have recently developed a Smart Physiotherapy Activity Recognition System (SPARS) for tracking home shoulder physiotherapy exercises using sensors in a commercial smart watch and artificial intelligence (AI). SPARS was successful in identifying shoulder exercises in healthy adults in the laboratory setting, and in patients undergoing physiotherapy for rotator cuff pathology. Further inquiry is required to establish the clinical effectiveness of this technology for tracking and improving patient engagement, and to investigate the potential individual impacts of its use.
Detailed description
The Research Team will conduct in-person data collection on 30 patients, by recording patients' exercises during their supervised physiotherapy sessions each week using the SPARS smart watch. Each patient will wear the 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 and the exercise is started on the tablet. An app installed on the provided Android smart tablet allows the patient to view their assigned exercises, videos showing them how to perform those exercises, and the record of their tracked participation. A tablet app will also be available to the treating physiotherapist to allow them to view this same data. The purpose of the participation tracking is to promote better patient engagement in the home component of physiotherapy.
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. Physical therapy of the patient population will be recruited from referrals by the Sunnybrook Shoulder and Upper Extremity Program funded by study grants. Data collection will be collected at each supervised physiotherapy session during the course of a patient's treatment. 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
- Model description
- Device: Smart Physiotherapy Activity Recognition System (SPARS)
| Arm | Type | Receives |
|---|---|---|
| Experimental: 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. |
| Active Comparator: 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
- Diagnosed with rotator cuff tendinosis, shoulder impingement syndrome, or degenerative or traumatic rotator cuff tear
- Planned conservative (non-operative) management
- Capacity to participate in home shoulder physiotherapy
Key exclusion criteria (3 listed)
- Upper extremity neurologic deficit
- Symptomatic contralateral shoulder with limited mobility requiring treatment
- Failed surgical management of rotator cuff pathology
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) and the exercise is started on the tablet, while patients are performing physiotherapy exercises. | Device | Active Comparator: OHIP (funded) Patient Population, Experimental: Injured Worker Population |
Primary outcome
Physiotherapy participation (Minutes weekly physiotherapy)
Time frame: Up to 3-5 months
Investigators will recruit up to 30 patients with rotator cuff pathology. Watch will begin recording inertial sensor data when it is put on by a patient during supervised and home physiotherapy exercises and the exercise is started on the tablet, and will stop recording when it is removed and the exercise is stopped on the tablet. Inertial data will be analyzed to generate quantitative measures of at-home physiotherapy participation in comparison to each patient's current physiotherapy prescription. Participation will be measured in minutes of weekly physiotherapy participation. Participation measurement will be compared to historical controls to detect statistically significant differences resulting from the use of apps by patients and their physiotherapists.
6 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
The American Shoulder and Elbow Society (ASES) 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 11 Aug 2025.
- Individual participant dataSharing planned: No
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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Effects of Scapular Stabilization on Rotator Cuff Strength, Shoulder Pain, Ansd Function
Shoulder Pain and Stiffness
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Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
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RecruitingObservational study
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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.
Helen Razmjou principal investigator
Sunnybrook Holland Orthopaedic & Arthritic 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 11 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 (Minutes weekly physiotherapy) (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?
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 11 Aug 2025.