NCT01807728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

March 1, 2013

Last Update Submit

March 4, 2024

Conditions

Spinal Cord Injuries

Keywords

Quality of lifeParticipationTraining

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from baseline in quality of life at 1 month

    Baseline, 1 month

Study Arms (2)

Group 1 Training Program

EXPERIMENTAL

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

Group 2 Training Program

EXPERIMENTAL

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

Interventions

Group 1 Training ProgramOTHER

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

Group 1 Training Program
Group 2 Training ProgramOTHER

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

Group 2 Training Program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Cognitive impairment that could interfere with learning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

South Florida Spinal Cord Injury System

Miami, Florida, 33136, United States

Location

Midwest Regional Spinal Cord Injury Care System

Chicago, Illinois, 60611, United States

Location

Northern New Jersey Spinal Cord System

West Orange, New Jersey, 07052, United States

Location

Debbie

Pittsburgh, Pennsylvania, 15101, United States

Location

Related Publications (2)

  • 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.

    PMID: 34174224DERIVED

  • 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.

    PMID: 32809896DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Michael Boninger, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 8, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2015

Study Completion

March 12, 2018

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

US(4)