NCT04629417

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2024

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2024

Enrollment Period

4.8 years

First QC Date

August 14, 2020

Last Update Submit

August 5, 2025

Conditions

Keywords

RehabilitationArtificial IntelligenceWearable Electronic DevicesAdherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • Strength testing

    Up to 12 weeks

  • Shoulder active range of motion

    Up to 12 weeks

Study Arms (2)

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)

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

Wearable smart watch that records inertial data such as (accelerometer, gyroscope magnetometer) while patients are performing physiotherapy exercises.

Injured Worker PopulationOHIP (funded) Patient Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females over the age of 18
  • Be diagnosed with rotator cuff tendinosis, shoulder impingement syndrome or a rotator cuff tear
  • Will be undergoing planned conservative management
  • Be able to participate in home physiotherapy exercises

You may not qualify if:

  • Upper extremity neurological deficit
  • Have had a previous failed surgery on the shoulder that is currently being treated
  • Undergoing simultaneous treatment for both shoulders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

Related Publications (8)

  • 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.

    PMID: 27582966BACKGROUND
  • 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.

    PMID: 26510584BACKGROUND
  • 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.

    PMID: 20163979BACKGROUND
  • 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.

    PMID: 26244112BACKGROUND
  • 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.

    PMID: 24972606BACKGROUND
  • 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.

    PMID: 29952759BACKGROUND
  • 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.

    PMID: 11382253BACKGROUND
  • 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.

    PMID: 19683414BACKGROUND

Study Officials

  • Robin Richards

    Sunnybrook Health Sciences 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

Study Record Dates

First Submitted

August 14, 2020

First Posted

November 16, 2020

Study Start

May 14, 2019

Primary Completion

February 16, 2024

Study Completion

February 16, 2024

Last Updated

August 7, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations