Wellclub Shoulder Therapy Outcome Validation
Primary Purpose
Shoulder Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WellClub
Standard Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain
Eligibility Criteria
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)
Sites / Locations
- Fairview - Institute for Athletic Medicine
- Fairview - Institute for Athletic Medicine
- Fairview - Institute for Athletic Medicine
- University Orthopaedic Therapy Center
- Fairview - Institute for Athletic Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WellClub Device
Standard Therapy
Arm Description
Hand held device that patients use for home therapy
Standard care therapy for should pain
Outcomes
Primary Outcome Measures
Change in performance measured by percentages
Percentage of completed exercises correctly completed by the patient
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
Change in degrees of shoulder range of motion
Change in range of motion on metered scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02954185
First Posted
October 7, 2016
Last Updated
January 22, 2020
Sponsor
University of Minnesota
Collaborators
Fairview Sports Physical Therapy Program
1. Study Identification
Unique Protocol Identification Number
NCT02954185
Brief Title
Wellclub Shoulder Therapy Outcome Validation
Official Title
Wellclub Shoulder Therapy Outcome Validation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment/Financial Issues
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Fairview Sports Physical Therapy Program
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WellClub Device
Arm Type
Experimental
Arm Description
Hand held device that patients use for home therapy
Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
Standard care therapy for should pain
Intervention Type
Other
Intervention Name(s)
WellClub
Intervention Type
Behavioral
Intervention Name(s)
Standard Therapy
Primary Outcome Measure Information:
Title
Change in performance measured by percentages
Description
Percentage of completed exercises correctly completed by the patient
Time Frame
Baseline and 6 weeks
Title
Change in score on SPADI (Shoulder Pain And Disability Index)
Description
SPADI is a scale consisting of 0-10 0 being the best and 10 being the worse pain ever
Time Frame
Baseline and 6 weeks
Title
Change in degrees of shoulder range of motion
Description
Change in range of motion on metered scale
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ames, PT PhD
Organizational Affiliation
Fairview Sports Physical Therapy Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fairview - Institute for Athletic Medicine
City
Blaine
State/Province
Minnesota
ZIP/Postal Code
55449
Country
United States
Facility Name
Fairview - Institute for Athletic Medicine
City
Eden Prairie
State/Province
Minnesota
ZIP/Postal Code
55344
Country
United States
Facility Name
Fairview - Institute for Athletic Medicine
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University Orthopaedic Therapy Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Fairview - Institute for Athletic Medicine
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55116
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Wellclub Shoulder Therapy Outcome Validation
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