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Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 1 Training Program
Group 2 Training Program
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Quality of life, Participation, Training

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Florida Spinal Cord Injury System
  • Midwest Regional Spinal Cord Injury Care System
  • Northern New Jersey Spinal Cord System
  • Debbie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 Training Program

Group 2 Training Program

Arm Description

For Group 1, participants will aim to be recruited within the first week of their inpatient rehabilitation stay (admission time point).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 1, 2013
Last Updated
March 3, 2023
Sponsor
University of Pittsburgh
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT01807728
Brief Title
Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
Official Title
Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Quality of life, Participation, Training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Training Program
Arm Type
Experimental
Arm Description
For Group 1, participants will aim to be recruited within the first week of their inpatient rehabilitation stay (admission time point).
Arm Title
Group 2 Training Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Group 1 Training Program
Intervention Description
Up to four group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).
Intervention Type
Other
Intervention Name(s)
Group 2 Training Program
Intervention Description
Two group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).
Primary Outcome Measure Information:
Title
Change from baseline in quality of life at 1 year
Description
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.
Time Frame
Baseline, 1 Year
Secondary Outcome Measure Information:
Title
Change from baseline in quality of life at 1 month
Description
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.
Time Frame
Baseline, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Boninger, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Florida Spinal Cord Injury System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Midwest Regional Spinal Cord Injury Care System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northern New Jersey Spinal Cord System
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Debbie
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34174224
Citation
Worobey LA, McKernan G, Toro M, Pearlman J, Cowan RE, Heinemann AW, Dyson-Hudson TA, Pedersen JP, Mesoros M, Boninger ML. Effectiveness of Group Wheelchair Maintenance Training for People with Spinal Cord Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Apr;103(4):790-797. doi: 10.1016/j.apmr.2021.02.031. Epub 2021 Jun 24.
Results Reference
derived
PubMed Identifier
32809896
Citation
Worobey LA, Kirby RL, Cowan RE, Dyson-Hudson TA, Shea M, Heinemann AW, Pedersen JP, Hibbs R, Boninger ML. Using remote learning to teach clinicians manual wheelchair skills: a cohort study with pre- vs post-training comparisons. Disabil Rehabil Assist Technol. 2022 Oct;17(7):752-759. doi: 10.1080/17483107.2020.1804633. Epub 2020 Aug 18.
Results Reference
derived

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Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

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