Spinal Cord InjuriesNCT01807728
Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
A study testing Group 1 Training Program and Group 2 Training Program in people with Spinal Cord Injuries, run by University of Pittsburgh at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Group 1 Training Program and Group 2 Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2013to 12 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cognitive impairment that could interfere with learning
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Midwest Regional Spinal Cord Injury Care System
Chicago, Illinois, 60611
South Florida Spinal Cord Injury System
Miami, Florida, 33136
Debbie
Pittsburgh, Pennsylvania, 15101
Northern New Jersey Spinal Cord System
West Orange, New Jersey, 07052
About this study
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Group 1 Training Program, Group 2 Training Program
- Keywords
- Quality of life, Participation, Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 2 Training ProgramOther
Two group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Group 2 Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 Year
Secondary outcomes (1)
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.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Michael Boninger, University of Pittsburgh
- Investigators
- Michael Boninger, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807728
- Sponsor's protocol ID
- 12090536
- Other IDs
- H133A120004
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2013
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34174224Worobey 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.
PubMed 32809896
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Programs to Improve Outcomes for Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01807728
- Acronym / sponsor ID
- 12090536
- Conditions
- Spinal Cord Injuries
- Keywords
- Quality of life, Participation, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Aug 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Training Program | Experimental | Other: Group 1 Training ProgramFor Group 1, participants will aim to be recruited within the first week of their inpatient rehabilitation stay (admission time point). |
| Group 2 Training Program | Experimental | Other: Group 2 Training ProgramFor 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Cognitive impairment that could interfere with learning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 Training ProgramUp to four group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s). | Other | Group 1 Training Program |
| Group 2 Training ProgramTwo group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s). | Other | Group 2 Training Program |
Primary outcome
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.
1 secondary outcome
Change from baseline in quality of life at 1 month
Time frame: Baseline, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 34174224Worobey 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.
- Derived from this study: PubMed 32809896Worobey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Boninger, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 Training Program and Group 2 Training Program in people with Spinal Cord Injuries, run by University of Pittsburgh at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in quality of life at 1 year (time frame: Baseline, 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807728, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.