Natural History of Shoulder Pathology in Manual Wheelchair Users (NHSSI)

September 12, 2025 updated by: The University of Texas Medical Branch, Galveston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

50 new manual wheelchair users with traumatic or non-traumatic spinal cord injuries (SCI) will be recruited & consented during the first 2 years of this project. Subjects will be recruited at sites that treat & rehabilitate people with acute SCI. SE MN & neighboring states will be the 1st regions of recruitment. The inclusion and exclusion criteria were chosen to include a sample of the population of people with new SCIs who will use MWCs as their primary mode of mobility inside and outside the home. For 25 SCI participants, an age, sex, and activity level able-bodied matched participant will be recruited from the SE MN area.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Manual Wheelchair User Cohort

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.
Matched Able-bodied Cohort

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, health status, and job type.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant completion of MRI and Field measurements after 3 to 5 years follow-up.
Time Frame: 3-5 years
Investigators will use the standardized MRI Assessment of the shoulder guide to assess shoulder pathology and compare baseline shoulder condition on MRI to yearly follow-up. For the purposes of grading, pathology aside from rotator cuff tears will be assessed on an ordinal scale from 0-3 with 0 indicating no abnormality, 1 mild, 2 moderate, and 3 severe. Field measurements will be used to determine changes in upper extremity motion and loading from baseline across 3-5 years of follow-up.
3-5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Development of the Conceptual Model of Preclinical Natural History of Shoulder Health Decline.
Time Frame: 3-5 years
Investigators will model the preclinical phase of shoulder health decline based on the Natural History of Disease. The exposure variables are defined by the upper extremity motion and loading, and the biological onset of the disease and pattern of disease development will be defined with the MRI findings of pathology type, location, and severity. Using regression techniques, an exposure-response relationship will be defined.
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Medical Branch, Galveston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mayo Clinic
West Virginia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa Morrow, University of Texas Medical Branch, Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-0127
  • 15-004974 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This will be decided further into the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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