Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807728
• Other study ID #: 12090536
• Secondary ID: H133A120004
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: March 12, 2018

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 12, 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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).
• Group 2 Training Program
Two group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).

Locations

Country	Name	City	State
United States	Midwest Regional Spinal Cord Injury Care System	Chicago	Illinois
United States	South Florida Spinal Cord Injury System	Miami	Florida
United States	Debbie	Pittsburgh	Pennsylvania
United States	Northern New Jersey Spinal Cord System	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in quality of life at 1 year	Predict mode of mobility at 1 year post-discharge based on patient characteristics and activity during IPR using a minimum data collection window. Predict ambulatory ability at 1 year post-discharge based on patient characteristics and measures of non-purposeful activity.	Baseline, 1 Year
Secondary	Change from baseline in quality of life at 1 month	Predict mode of mobility at discharge or 1 month based on patient characteristics and activity during IPR using a minimum data collection window. Predict ambulatory ability at discharge or 1 month based on patient characteristics and measures of non-purposeful activity.	Baseline, 1 month