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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
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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)

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

First Posted
October 7, 2016
Last Updated
January 22, 2020
Sponsor
University of Minnesota
Collaborators
Fairview Sports Physical Therapy Program
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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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