Wellclub Shoulder Therapy Outcome Validation

Not Applicable

Terminated

• Conditions: Shoulder Pain
• Interventions: Behavioral: Standard Therapy; Other: WellClub

• Registration Number: NCT02954185
• Lead Sponsor: University of Minnesota

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-10-07
• Study Start: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Primary Completion: 2018-08-23
• Study Completion: 2018-08-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Shoulder impingement not requiring immediate surgery

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Standard Therapy	Standard care therapy for should pain
WellClub Device	WellClub	Hand held device that patients use for home therapy

Primary Outcome Measures

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

Trial Locations

Locations (2)

Fairview - Institute for Athletic Medicine; 🇺🇸 Saint Paul, Minnesota, United States

University Orthopaedic Therapy Center; 🇺🇸 Minneapolis, Minnesota, United States