MedPath

Novel Shoulder Rehabilitation Program (SPARS-REHAB)

Not Applicable
Active, not recruiting
Conditions
Rotator Cuff Pathology
Interventions
Device: Smart Physiotherapy Activity Recognition System (SPARS)
Registration Number
NCT05139173
Lead Sponsor
Sunnybrook Health Sciences Centre
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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
25
Inclusion Criteria
  1. Males and females over the age of 18
  2. Diagnosed with rotator cuff tendinosis, shoulder impingement syndrome, or degenerative or traumatic rotator cuff tear
  3. Planned conservative (non-operative) management
  4. Capacity to participate in home shoulder physiotherapy
Exclusion Criteria
  1. Upper extremity neurologic deficit
  2. Symptomatic contralateral shoulder with limited mobility requiring treatment
  3. Failed surgical management of rotator cuff pathology

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental: Injured Worker PopulationSmart 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 PopulationSmart 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.
Primary Outcome Measures
NameTimeMethod
Physiotherapy participation (Minutes weekly physiotherapy)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 Outcome Measures
NameTimeMethod
Strength testingUp to 12 weeks

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

Numeric Pain Rating Scale (NPRS)Up to 1 year

Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.

Work statusUp to 1 year

Clinical and return to work outcome data full-time, part-time, off-work, modified or regular duties.

The Disabilities of the Arm, Shoulder and Hand (DASH) ScoreUp 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.

The American Shoulder and Elbow Society (ASES) ScoreUp 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.

Shoulder active range of motionUp to 12 weeks

Measured by a handheld goniometer

Trial Locations

Locations (1)

Sunnybrook Holland Orthopaedic & Arthritic Centre

🇨🇦

Toronto, Ontario, Canada

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