Wellclub Shoulder Therapy Outcome Validation

University of Minnesota (UMN)

Status: Terminated

Conditions: Shoulder Pain

Treatments: Behavioral: Standard Therapy; Other: WellClub

Study type: Interventional

Funder types: Other

Identifiers

NCT02954185

1607M91681

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

WellClub Device

Experimental group

Description:

Hand held device that patients use for home therapy

Treatment:

Other: WellClub

Standard Therapy

Active Comparator group

Description:

Standard care therapy for should pain

Treatment:

Behavioral: Standard Therapy