Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury

NCT ID: NCT01807728

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-03-12

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Group 1 Training Program

Intervention Type OTHER

Up to four group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).

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.

Group Type EXPERIMENTAL

Group 2 Training Program

Intervention Type OTHER

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

Interventions

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Group 1 Training Program

Up to four group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).

Intervention Type OTHER

Group 2 Training Program

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Michael Boninger

Chair, Department of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Boninger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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South Florida Spinal Cord Injury System

Miami, Florida, United States

Site Status

Midwest Regional Spinal Cord Injury Care System

Chicago, Illinois, United States

Site Status

Northern New Jersey Spinal Cord System

West Orange, New Jersey, United States

Site Status

Debbie

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34174224 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32809896 (View on PubMed)

Other Identifiers

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H133A120004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12090536

Identifier Type: -

Identifier Source: org_study_id

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