Natural History of Shoulder Pathology in Manual Wheelchair Users

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Brief Title

Natural History of Shoulder Pathology in Manual Wheelchair Users

Official Title

Natural History of Shoulder Pathology in Manual Wheelchair Users

Brief Summary

      Over 300,000 people in the United States have spinal cord injuries and many use manual
      wheelchairs for mobility. Most manual wheelchair users will develop shoulder injuries and
      pain that greatly affect quality of life and level of independence. Understanding when
      shoulder disease starts in manual wheelchair users and which daily activities contribute to
      the disease will provide necessary evidence for effective primary prevention methods to
      inhibit the development of further disability. Our central hypothesis is that the development
      of shoulder disease in manual wheelchair users will be strongly associated with the
      cumulative exposure to elevated shoulder postures combined with high upper body loading.
    

Detailed Description

      Of the 1.7 million wheelchair users in the United States (US), 90 percent, or 1.5 million
      persons use manual wheelchairs (MWCs). People with traumatic and non-traumatic spinal cord
      injuries (SCI) make up approximately 20% of the MWC users, and 12,000 new traumatic SCIs
      occur every year. While MWCs are immediately available and enable independence, 63% of MWC
      users will have one or multiple rotator cuff tears after decades of MWC use as compared to
      15% of age-matched able-bodied adults. A crucial gap in knowledge exists in understanding how
      the shoulder of MWC users functions from an almost permanent seated position as an agent for
      mobility, weight bearing, and hand grasping; and how this altered function translates to
      longitudinal shoulder health decline.

      The objective of this application is to define the longitudinal components of the early phase
      (before chronic symptom onset) of shoulder health decline specific to new MWC users by
      characterizing the exposure to altered shoulder function and the associated MRI signs of
      early onset of shoulder pathology. The investigators propose to: (Aim 1) quantify shoulder
      joint motion and loading in the real world over 3 years in 50 new MWC users and a matched
      able-bodied cohort; (Aim 2) define early, preclinical changes on shoulder MRI specific to the
      MWC users, over 3 years, in comparison to the matched cohort; and (Aim 3) identify specific
      exposure measures as risk factors for early changes on MRI in the MWC users. Three central
      and novel aspects of this proposal will pave the way for targeting primary prevention: (1)
      characterizing the altered shoulder function in new MWC users in the real world with hardware
      and instrumentation suitable for multiple, day long collections, (2) defining the early,
      preclinical pattern of disease in users compared to a matched able-bodied cohort, and
      (3)investigating the combined effect of shoulder motion and loading and its relationship to
      the incidence of shoulder pathology.

      Successful completion of this project will define how the shoulder responds to MWC use (Aim
      1), identify the MWC-specific pattern of shoulder disease on MRI (Aim 2), and determine how
      altered shoulder function has contributed to shoulder health decline (Aim 3). This work
      provides the foundation for understanding the relative impact of shoulder elevation and
      loading in shoulder health decline. Additionally, this work provides the first building block
      in defining the complete natural history of shoulder disease in MWC users. The investigators
      expect the overall impact to be a powerful influence on environmental and assistive
      technology redesign, post-SCI rehabilitation practices, insurance reimbursement for shoulder
      health-preserving equipment, and understanding shoulder pathology in the general population.
    


Study Type

Observational


Primary Outcome

Participant completion of MRI and Field measurements after 3 to 5 years follow-up.

Secondary Outcome

 Development of the Conceptual Model of Preclinical Natural History of Shoulder Health Decline.

Condition

Paraplegia


Study Arms / Comparison Groups

 Manual Wheelchair User Cohort
Description:  Physical Exam. Screening exam performed by a licensed physical therapist to confirm inclusion/exclusion criteria.
Assessment of Shoulder Function in Everyday Life. Shoulder motion & hand loading data will be collected over a few days, twice per yr for 3-5 yrs in home & community environment.
Magnetic Resonance Imaging (MRI) of Shoulders. Imaging will use standard clinical protocol once per yr for 3-5 yrs.
Shoulder Strength Testing. Once per yr for 3-5 yrs. Additional Variables. Updated demographic info will be collected yearly including but not limited to weight, chair type, health status, and job type.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

75

Start Date

November 2015

Completion Date

May 2022

Primary Completion Date

May 2022

Eligibility Criteria

        Inclusion Criteria:

        Group1 (Manual Wheelchair User Cohort):

          -  Participants with traumatic or non-traumatic spinal cord injury who have begun using a
             MWC within 12 months of enrollment

          -  18 - 70 years of age

          -  Use of a manual wheelchair as the primary mode of mobility

          -  Functional upper extremity range of motion

          -  Willingness to participate in study

          -  Ability to return to receive shoulder MRI 1-3 times/year , and once per year receive
             physical exam, and strength assessments.

        Group 2 (Matched Able-bodied Cohort):

          -  18-70 years of age

          -  Able to walk independently with no reliance on an orthotic, prosthetic, or gait aid

          -  Functional upper extremity range of motion

          -  Willingness to participate in study

          -  Ability to receive shoulder MRI 1-3 times/year, and once per year receive physical
             exam, and strength assessments.

        Exclusion Criteria:

        Group1 (Manual Wheelchair User Cohort):

        • Previous diagnosis of bilateral shoulder tendon tears prior to spinal cord injury or
        suspected tendon tears with physical exam

        Group 2 (Matched Able-bodied Cohort):

          -  Any documented musculoskeletal or neurological disorders that would be expected to
             impact shoulder health or change ability to walk independently

          -  Previous diagnosis of shoulder tears prior to enrollment or suspected tendon tears
             with physical exam
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Melissa M Morrow, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02600910

Organization ID

15-004974


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

Melissa M Morrow, Ph.D., Principal Investigator, Mayo Clinic


Verification Date

January 2021