Wellclub Shoulder Therapy Outcome Validation



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 99
Updated:10/13/2018
Start Date:November 2016
End Date:December 2019
Contact:Peter Ames, PT PhD
Email:pames1@fairview.org
Phone:952-944-2314

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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.

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.

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)
We found this trial at
5
sites
2512 South 7th Street
Minneapolis, Minnesota 55454
Phone: 612-273-7100
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1750 105th Avenue Northeast
Blaine, Minnesota 55449
Phone: 763-780-0356
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Blaine, MN
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775 Prairie Center Drive
Eden Prairie, Minnesota 55344
Phone: 952-944-5314
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Eden Prairie, MN
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14101 Fairview Drive
Edina, Minnesota 55435
Phone: 952-920-8525
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Edina, MN
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2155 Ford Parkway
Saint Paul, Minnesota 55116
Phone: 651-696-5010
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Saint Paul, MN
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