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Recruitment/Financial Issues
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| Name | Class |
|---|---|
| Fairview Sports Physical Therapy Program | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WellClub Device | Experimental | Hand held device that patients use for home therapy |
|
| Standard Therapy | Active Comparator | Standard care therapy for should pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WellClub | Other |
| ||
| Standard Therapy |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Ames, PT PhD | Fairview Sports Physical Therapy Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairview - Institute for Athletic Medicine | Blaine | Minnesota | 55449 | United States | ||
| Fairview - Institute for Athletic Medicine |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Eden Prairie |
| Minnesota |
| 55344 |
| United States |
| Fairview - Institute for Athletic Medicine | Edina | Minnesota | 55435 | United States |
| University Orthopaedic Therapy Center | Minneapolis | Minnesota | 55454 | United States |
| Fairview - Institute for Athletic Medicine | Saint Paul | Minnesota | 55116 | United States |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |