Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

March 4, 2024 updated by: Michael Boninger, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • South Florida Spinal Cord Injury System
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Midwest Regional Spinal Cord Injury Care System
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Northern New Jersey Spinal Cord System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15101
        • Debbie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 Training Program
For Group 1, participants will aim to be recruited within the first week of their inpatient rehabilitation stay (admission time point).
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
For Group 2, individuals may be enrolled in the study at any time over their inpatient rehabilitation stay. Data collection may occur at admission (Group 2 only), just prior to discharge and at 3, 6 and 12 months after discharge.
Other: Group 2 Training Program
Two group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life at 1 year
Time Frame: Baseline, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of life at 1 month
Time Frame: Baseline, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Michael Boninger, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

March 12, 2018

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimated)

March 8, 2013

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12090536
  • H133A120004 (Other Grant/Funding Number: U.S. Department of Education)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on Group 1 Training Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe