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Trial record 8 of 25 for:    Spinal Cord Injuries | ( Map: Minnesota, United States )

Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI

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ClinicalTrials.gov Identifier: NCT02777281
Recruitment Status : Suspended (Funding)
First Posted : May 19, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
This study will compare two exercise programs in an interventional study for manual wheelchair users with spinal cord injury and shoulder pain. Subjects without spinal cord injury will also be enrolled to compare exercise approaches.

Condition or disease Intervention/treatment Phase
Shoulder Pain Spinal Cord Injury Behavioral: Shoulder pain and SCI Behavioral: Shoulder pain and able bodies Not Applicable

Detailed Description:
The investigators hypothesis is that the biomechanically based exercise program will demonstrate greater muscle activation of targeted muscles, and reduced compression risk to the rotator cuff tendons.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Shoulder pain and SCI
Manual wheelchair users with SCI
Behavioral: Shoulder pain and SCI
Shoulder pain and SCI

Shoulder pain and able bodies
No SCI or wheelchair use but presence of shoulder pain
Behavioral: Shoulder pain and able bodies



Primary Outcome Measures :
  1. Muscle activity [ Time Frame: baseline ]
    Muscle activity during exercises is measured as a change in EMG

  2. Rotator cuff compression risk [ Time Frame: baseline ]
    Motion and position data of the upper arm relative to the shoulder blade measured in degrees



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Persons with paraplegia at least 1 year post SCI. Prior to this time patients are still adjusting to independent function with manual wheelchairs as their primary means of mobility. This criteria ensures the subjects have had sufficient exposure to the functional demands associated with their condition.
  2. Age 21 to 60 years old; below age 21, particularly in males, the humeral growth plate may not have fully closed. Including subjects above this age ensures skeletal maturity. After age 60, even in able-bodied individuals, substantial degenerative changes can begin to occur in the shoulder joint.
  3. Use of a manual wheelchair as the primary means of mobility (> 50% time). This is the population with most risk of development of shoulder pain and associated secondary complications.
  4. A history of unilateral or bilateral shoulder pain that interferes with at least one functional task. Symptoms localized to the proximal anterior, lateral, or posterior glenohumeral (shoulder joint) region are required. Rotator cuff tendinopathy and "impingement" syndromes involve localized pain in this region. More diffuse symptoms are consistent with combined shoulder/neck syndromes or radiating pain from cervical spine pathology.

Exclusion Criteria:

  1. Inability to provide informed consent.
  2. Reproduction of shoulder pain, pain radiating down the upper extremity, numbness or tingling in the upper extremity, or other upper extremity symptoms during a cervical screening examination or thoracic outlet testing. This result would be indicative of primary cervical or thoracic outlet pathology.
  3. Shoulder pain of traumatic origin. Cumulative trauma disorders are of primary interest and most amenable to the proposed exercise interventions.
  4. History of shoulder surgery or dislocation.
  5. Recent history of fracture (within 1 year), hospitalization (within the past month), or cortisone injection to the shoulder (within 4 months). These conditions may interfere with safe or effective completion of the exercise intervention.
  6. A diagnosis or imaging findings of rheumatoid arthritis, end stage osteoarthritis, full thickness rotator cuff tear, adhesive capsulitis, or complex regional pain syndrome. These subjects may have joint disease progression that is severe, or not appropriately treated with a stretching and strengthening intervention.
  7. Diagnosed major depression, alcohol or substance abuse, or other serious medical conditions. These conditions may prevent subjects from regularly completing the exercise intervention

All criteria apply to both groups excepting manual wheelchair use and SCI criteria not applicable to the able bodied subject group.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777281


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Paula M Ludewig, PhD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02777281     History of Changes
Other Study ID Numbers: SCIR01HD080857-01
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Shoulder Pain
Wheelchair
Spinal Cord injury

Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Shoulder Pain
Central Nervous System Diseases
Nervous System Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms