SPARS Rehabilitation Program for Rotator Cuff Injury

(SPARS-REHAB Trial)

Overseen By Helen Razmjou

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Neurologic deficit, Contralateral shoulder, Failed surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3-5 months

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the SPARS treatment for rotator cuff injury?

The research on at-home physiotherapy using smart technology shows that using a smartwatch to track exercises can improve the accuracy of exercise classification and patient engagement, which is important for rehabilitation. Additionally, a study on a similar smart textile system for shoulder pain showed that patients using the technology had better recovery outcomes, suggesting that smart systems like SPARS could be effective for rotator cuff rehabilitation. ^{1 2 3 4 5}

Is the SPARS Rehabilitation Program for Rotator Cuff Injury safe for humans?

The available research does not provide specific safety data for the SPARS Rehabilitation Program or similar systems, but studies involving wearable sensors and physiotherapy exercises for rotator cuff injuries generally focus on monitoring and improving rehabilitation without indicating safety concerns. ^{4 6 7 8 9}

How is the SPARS Rehabilitation Program for Rotator Cuff Injury different from other treatments?

The SPARS Rehabilitation Program is unique because it likely incorporates telerehabilitation, which allows patients to perform exercises at home while being monitored remotely, enhancing engagement and outcomes. This approach is different from traditional in-clinic physiotherapy, as it uses technology to track adherence and provide feedback, potentially improving recovery for rotator cuff injuries. ^{2 3 4 5 10}

Research Team

Helen Razmjou

Principal Investigator

Sunnybrook Holland Orthopaedic & Arthritic Centre

Eligibility Criteria

This trial is for men and women over 18 who can do shoulder physiotherapy at home. They must have a rotator cuff injury like tendinosis, impingement syndrome, or a tear that's being treated without surgery. People with issues in the other shoulder, failed shoulder surgery, or nerve problems in the arm can't join.

Inclusion Criteria

I am over 18 years old.

I am planning to manage my condition without surgery.

I have been diagnosed with a shoulder condition or injury affecting the rotator cuff.

Exclusion Criteria

My other shoulder is painful and I can't move it well, needing treatment.

My shoulder surgery for a torn rotator cuff did not work.

I have weakness or numbness in my arm or hand.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo physiotherapy with SPARS smart watch tracking during supervised and home exercises

3-5 months

Weekly supervised physiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and shoulder testing

Up to 1 year

Monthly follow-up visits, final treatment session, and 1-year follow-up

Treatment Details

Interventions

• Smart Physiotherapy Activity Recognition System (SPARS)

Trial Overview The study tests a new system called SPARS that uses smartwatches and AI to track how well patients follow their home-based shoulder physiotherapy routines. It aims to see if this tech improves patient engagement and recovery from common shoulder injuries.

Participant Groups

Group I: Experimental: Injured Worker Population Experimental Treatment 1 Intervention

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.

Group II: Active Comparator: OHIP (funded) Patient Population Active Control 1 Intervention

Participants that have a confirmed rotator cuff pathology, and are undergoing physiotherapy at the Holland Centre as part of the Shoulder Program.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A randomized controlled trial showed that patients with subacromial pain syndrome using the DAid smart shirt experienced significantly better recovery outcomes compared to a reference group, as measured by standardized tests (p < 0.001).

The DAid smart shirt provides real-time feedback on shoulder motion, helping patients perform exercises more accurately, which enhances muscle control and contributes to improved rehabilitation results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt. Semjonova, G., Vetra, J., Cauce, V., et al.[2021]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Functional outcomes after physiotherapy program in patients with massive and irreparable rotator cuff tear. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of early versus delayed rehabilitation following rotator cuff repair: Systematic review and meta-analyses. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of at-home physiotherapy. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Improving the Recovery of Patients with Subacromial Pain Syndrome with the DAid Smart Textile Shirt. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Quantifying shoulder activity after rotator cuff repair: Technique and preliminary results. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Exercise into pain in chronic rotator cuff related shoulder pain: a prospective single-group feasibility study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Reporting of Patient-Reported Outcome Measures in Randomized Controlled Trials on Shoulder Rotator Cuff Injuries Is Suboptimal and Requires Standardization. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Accelerometry as an objective measure of upper-extremity activity. [2021]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Proposal and Evaluation of a Telerehabilitation Platform Designed for Patients With Partial Rotator Cuff Tears: A Preliminary Study. [2020]