Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence

Rotator Cuff Pathology Clinical Trial

— SPARS  

Official title:

Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04629417
• Other study ID #: SPARS2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: April 30, 2024
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females over the age of 18

2. Be diagnosed with rotator cuff tendinosis, shoulder impingement syndrome or a rotator cuff tear

3. Will be undergoing planned conservative management

4. Be able to participate in home physiotherapy exercises

Exclusion Criteria:

1. Upper extremity neurological deficit

2. Have had a previous failed surgery on the shoulder that is currently being treated

3. Undergoing simultaneous treatment for both shoulders

Related Conditions & MeSH terms

• Rotator Cuff Pathology

Intervention

Device:
• Smart Physiotherapy Activity Recognition System (SPARS)
Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) while patients are performing physiotherapy exercises.

Locations

Country	Name	City	State
Canada	Sunnybrook Holland Orthopaedic & Arthritic Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Beaton 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. — View Citation

Bollen 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. — View Citation

Burns 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. — View Citation

Faber 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. — View Citation

Jack 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. — View Citation

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. — View Citation

Staples 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. — View Citation

Thomson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3-5 months
Secondary	Work status	Clinical and return to work outcome data Full-time, part-time, off-work, modified or regular duties	Up to 1 year
Secondary	Numeric Pain Rating Scale (NPRS)	Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.	Up to 1 year
Secondary	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.	Up to 1 year
Secondary	Strength testing	Rotator cuff strength testing using manual muscle testing as well as strength testing with a dynamometer	Up to 12 weeks
Secondary	Shoulder active range of motion	Measured by handheld goniometer	Up to 12 weeks