Novel Shoulder Rehabilitation Program (SPARS-REHAB)

NCT05139173 | Completed

• 1 other identifier: SPARS-REHAB
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Rotator Cuff Pathology

Keywords

Rehabilitation; Artificial Intelligence; Wearable Electronic Devices; Adherence; Physiotherapy; Rotator Cuff Pathology

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3-5 months

Secondary Outcomes (6)

• Work status

  Up to 1 year

• Numeric Pain Rating Scale (NPRS)

  Up to 1 year

• The Disabilities of the Arm, Shoulder and Hand (DASH) Score

  Up to 1 year

• The American Shoulder and Elbow Society (ASES) Score

  Up to 1 year

• Strength testing

  Up to 12 weeks

Study Arms (2)

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.

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.

Device: Smart Physiotherapy Activity Recognition System (SPARS)

Interventions

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.

Active Comparator: OHIP (funded) Patient Population; Experimental: Injured Worker Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

Study Officials

• Helen Razmjou

  Sunnybrook Holland Orthopaedic & Arthritic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Device: Smart Physiotherapy Activity Recognition System (SPARS)

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 1, 2021
• Study Start: January 17, 2022
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: August 11, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)