Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Pittsburgh
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Michael Boninger, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01807728
First received: March 1, 2013
Last updated: December 10, 2014
Last verified: December 2014
  Purpose

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 Intervention
Spinal Cord Injuries
Other: Group 1 Training Program
Other: Group 2 Training Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change from baseline in quality of life at 1 year [ Time Frame: Baseline, 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in quality of life at 1 month [ Time Frame: Baseline, 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 680
Study Start Date: August 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807728

Contacts
Contact: Lynn Worobey, PhD 412-822-3674 law93@pitt.edu

Locations
United States, Florida
South Florida Spinal Cord Injury System Recruiting
Miami, Florida, United States, 33136
Contact: Rachel Cowan, PhD       RCowan@med.miami.edu   
Principal Investigator: Rachel Cowan, PhD         
United States, Illinois
Midwest Regional Spinal Cord Injury Care System Recruiting
Chicago, Illinois, United States, 60611
Contact: Allen Heinemann, PhD    312-238-1000    aheinemann@ric.org   
Principal Investigator: Allen Heinemann, PhD         
United States, New Jersey
Northern New Jersey Spinal Cord System Recruiting
West Orange, New Jersey, United States, 07052
Contact: Trevor Dyson-Hudson, MD       tdysonhudson@kesslerfoundation.org   
Principal Investigator: Trevor Dyson-Hudson, MD         
United States, Pennsylvania
University of Pittsburgh Model Center on Spinal Cord Injury Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Emily Krobot, MSW    412-822-3666    eak20@pitt.edu   
Principal Investigator: Michael Boninger, M.D.         
Sponsors and Collaborators
University of Pittsburgh
U.S. Department of Education
Investigators
Principal Investigator: Michael Boninger, M.D. University of Pittsburgh
  More Information

No publications provided

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
Study First Received: March 1, 2013
Last Updated: December 10, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Quality of life
Participation
Training

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

ClinicalTrials.gov processed this record on February 27, 2015