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Wellclub Shoulder Therapy Outcome Validation

Wellclub Shoulder Therapy Outcome Validation

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02954185
Enrollment
30
Registered
2016-11-03
Start date
2016-11-01
Completion date
2018-08-23
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Shoulder Pain

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.

Interventions

OTHERWellClub
BEHAVIORALStandard Therapy

Sponsors

Fairview Sports Physical Therapy Program
CollaboratorUNKNOWN
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in performance measured by percentagesBaseline and 6 weeksPercentage of completed exercises correctly completed by the patient
Change in score on SPADI (Shoulder Pain And Disability Index)Baseline and 6 weeksSPADI is a scale consisting of 0-10 0 being the best and 10 being the worse pain ever
Change in degrees of shoulder range of motionBaseline and 6 weeksChange in range of motion on metered scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026