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Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01807728
Recruitment Status : Active, not recruiting
First Posted : March 8, 2013
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh

Brief Summary:
The objective of this study is to determine the effectiveness of different training programs on outcomes in persons with spinal cord injury (SCI). We are interested to see which programs have the greatest impact.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Group 1 Training Program Other: Group 2 Training Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
Study Start Date : August 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1 Training Program Other: Group 1 Training Program
Up to four group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).
Experimental: Group 2 Training Program Other: Group 2 Training Program
Two group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).



Primary Outcome Measures :
  1. Change from baseline in quality of life at 1 year [ Time Frame: Baseline, 1 Year ]

Secondary Outcome Measures :
  1. Change from baseline in quality of life at 1 month [ Time Frame: Baseline, 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 75 years old
  • Use either a power or manual wheelchair as a primary means of mobility (>50% of weekly mobility)
  • Living in the community
  • Must have a non-progressive spinal cord injury
  • Manual wheelchair users must be able to independently propel their wheelchairs
  • Manual wheelchair users score ≤90 on the Wheelchair Skills Training Questionnaire (WST-Q)

Exclusion Criteria:

  • Cognitive impairment that could interfere with learning

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): NCT01807728


Locations
United States, Florida
South Florida Spinal Cord Injury System
Miami, Florida, United States, 33136
United States, Illinois
Midwest Regional Spinal Cord Injury Care System
Chicago, Illinois, United States, 60611
United States, New Jersey
Northern New Jersey Spinal Cord System
West Orange, New Jersey, United States, 07052
United States, Pennsylvania
University of Pittsburgh Model Center on Spinal Cord Injury
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
University of Pittsburgh
U.S. Department of Education
Investigators
Principal Investigator: Michael Boninger, M.D. University of Pittsburgh

Responsible Party: Michael Boninger, Chair, Department of Physical Medicine and Rehabilitation, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01807728     History of Changes
Other Study ID Numbers: 12090536
H133A120004 ( Other Grant/Funding Number: U.S. Department of Education )
First Posted: March 8, 2013    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by Michael Boninger, University of Pittsburgh:
Quality of life
Participation
Training

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System