Wellclub Shoulder Therapy Outcome Validation

NCT02954185 | Terminated

• 1 other identifier: 1607M91681
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Shoulder Pain

Keywords

Shoulder Pain

Outcome Measures

Primary Outcomes (3)

• Change in performance measured by percentages

  Percentage of completed exercises correctly completed by the patient

  Baseline and 6 weeks

• 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

  Baseline and 6 weeks

• Change in degrees of shoulder range of motion

  Change in range of motion on metered scale

  Baseline and 6 weeks

Study Arms (2)

WellClub Device

EXPERIMENTAL

Hand held device that patients use for home therapy

Other: WellClub

Standard Therapy

ACTIVE COMPARATOR

Standard care therapy for should pain

Behavioral: Standard Therapy

Interventions

WellClub OTHER

WellClub Device

Standard Therapy BEHAVIORAL

Standard Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Shoulder impingement not requiring immediate surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead
• Fairview Sports Physical Therapy Program: collaborator

Study Sites (5)

Fairview - Institute for Athletic Medicine

Blaine, Minnesota, 55449, United States

Location

Fairview - Institute for Athletic Medicine

Eden Prairie, Minnesota, 55344, United States

Location

Fairview - Institute for Athletic Medicine

Edina, Minnesota, 55435, United States

Location

University Orthopaedic Therapy Center

Minneapolis, Minnesota, 55454, United States

Location

Fairview - Institute for Athletic Medicine

Saint Paul, Minnesota, 55116, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Peter Ames, PT PhD

  Fairview Sports Physical Therapy Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: November 3, 2016
• Study Start: November 1, 2016
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (5)