Wellclub Shoulder Therapy Outcome Validation

Study Overview
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Brief Summary
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Preliminary evaluations have been completed and resulted in patients and therapist indicating positive outcomes through increased patient engagement, asynchronous communications (i.e. messaging) between therapists and patients, and objective assessment and monitoring of exercises performed by the patients. The investigator's hypothesis is that patients using the Wellclub device and application in addition to in-clinic physical therapy will be more compliant with their home exercise programs and have the same or better functional outcomes than patients with similar conditions who use in-clinic care only.

Detailed Description
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Patients seeking an initial outpatient physical therapy evaluation for non-surgical shoulder impingement with pain, who own iPhones with iOS 8 or later. Patients will be randomized into the study group or the control group, and be seen at least once per week by their physical therapist for the duration of the therapy episode, or up to 12 weeks. The study group will be asked to strap to their wrist a small, measurement device and download a smartphone application. The App communicates with the wearable device and reminds them to complete their therapy and provides patients visual instruction, feedback on exercise quality, and exercise count for the prescribed physical therapy. The control group will only have traditional in-clinic therapy as deemed clinically necessary by the PT.

Official Title
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Wellclub Shoulder Therapy Outcome Validation

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: WellClub
* Behavioral: Standard Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Shoulder impingement not requiring immediate surgery Exclusion Criteria: Rotator cuff tear (RCT) Surgical history of rotator cuff repair (RCR) Cortisone injection or other injectable for past 6 months Prescription NSAIDs in the past 6 months Frozen shoulder syndrome Neurological conditions Other orthopaedic conditions (spine/neck)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WellClub Device<br>Hand held device that patients use for home therapy | Other: WellClub<br> <br> |
| Active Comparator: Standard Therapy<br>Standard care therapy for should pain | Behavioral: Standard Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in performance measured by percentages | Percentage of completed exercises correctly completed by the patient | Baseline and 6 weeks | 
| Change in score on SPADI (Shoulder Pain And Disability Index) | SPADI is a scale consisting of 0-10 0 being the best and 10 being the worse pain ever | Baseline and 6 weeks | 
| Change in degrees of shoulder range of motion | Change in range of motion on metered scale | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Pain