Skip to main content
OpenTrials
Completed

NCT Number: NCT05139173

Novel Shoulder Rehabilitation Program (SPARS-REHAB)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rotator Cuff Pathology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Upper extremity neurologic deficit
  • Symptomatic contralateral shoulder with limited mobility requiring treatment
  • Failed surgical management of rotator cuff pathology

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  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. The American Shoulder and Elbow Society (ASES) Score

    Time frame: Up to 1 year

    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.

  5. Strength testing

    Time frame: Up to 12 weeks

    Rotator cuff strength testing using manual muscle testing as well as strength testing with a dynamometer.

  6. Shoulder active range of motion

    Time frame: Up to 12 weeks

    Measured by a handheld goniometer

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

User Centred Design and Pilot Testing of a Novel Shoulder Rehabilitation Program With Engagement Tracking

Acronym: SPARS-REHAB

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2021
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.