Natural History of Shoulder Pathology in Manual Wheelchair Users (NCT02600910) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Natural History of Shoulder Pathology in Manual Wheelchair Users
United States75 participantsStarted 2015-11
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant completion of MRI and Field measurements after 3 to 5 years follow-up.
Timeframe: 3-5 years
Trial details
NCT IDNCT02600910
SponsorThe University of Texas Medical Branch, Galveston