- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909061
Wheelchair Maintenance Training Program
Effectiveness of a Remote Wheelchair Maintenance Training Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Up to 100 individuals will be recruited for this research study. We will recruit individuals who use a wheelchair for the majority of their mobility (over 40 hours per week), and have a traumatic spinal cord injury (SCI). This study will be accessed entirely online and participation is expected to last approximately one year. Subjects will select to participate in one of three groups; one group that will receive maintenance training immediately with no follow up, one group that will receive the maintenance training immediately with 1 month and 6 month follow up, and one group that will be randomized to either receive the maintenance training immediately or after 6 months. The maintenance training program itself will take approximately 1-2 hours to complete.
After obtaining informed consent, participants in the first two groups will complete baseline questionnaires. They will then receive the maintenance training program.
Participants in the third group (a wait-list control group) will complete the baseline questionnaires and be contacted one month later to complete a wheelchair maintenance assessment questionnaire. They will then wait 5 months. After this period, participants will complete the baseline questionnaires a second time, and then receive the wheelchair maintenance training.
After completing the maintenance training, all groups will be contacted immediately post training to complete additional questionnaires to assess the effectiveness of the remote training program. Participants in the 2nd and 3rd group will be contacted 1 month and 6 months post-training to complete additional questionnaires. Participants may be compensated for their time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have a traumatic spinal cord injury
- Use a wheelchair as a primary means of mobility (>40 hours per week)
Exclusion Criteria:
- English is not a primary language
- Primary residence is not in the United States
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Training (no follow up)
Individuals may decide to participate in the research study training program, but not in any follow up questionnaires.
This group will have immediate access to the independent maintenance training materials.
They will complete data collection measures embedded in the maintenance training program, including demographics, Online Learning Readiness Scale (OLRS), Moorong Self Efficacy Scale (MSES), Patient Reported Outcome Measurement Information System (PROMIS), Assistive Technology Module Questionnaire (ATM-Q), and the Wheelchair Maintenance Training Questionnaire (WMT-Q).
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Wheelchair Maintenance Training Program: WMTP training consists of three parts.
It starts with an overview of basic wheelchair maintenance items, continues with the second section discussing how to inspect the parts of a wheelchair and finishes with the third section discussing how to perform wheelchair maintenance on a wheelchair.
Throughout the course, there are videos and pictures demonstrating the activities discussed in the training program.
Participants will also be informed when a repair requires professional assistance and where such assistance may be found.
|
|
Experimental: Immediate Training (with follow up)
Individuals may decide to participate in the research study, but do not want to be randomized.
After consent is obtained, these individuals will be directed immediately to the baseline questionnaires (see above) before and after the wheelchair maintenance training.
Participants may also be asked to complete a user satisfaction survey.
|
Wheelchair Maintenance Training Program: WMTP training consists of three parts.
It starts with an overview of basic wheelchair maintenance items, continues with the second section discussing how to inspect the parts of a wheelchair and finishes with the third section discussing how to perform wheelchair maintenance on a wheelchair.
Throughout the course, there are videos and pictures demonstrating the activities discussed in the training program.
Participants will also be informed when a repair requires professional assistance and where such assistance may be found.
|
|
Experimental: Randomized Training
Individuals may decide to participate in the research study and agree to be randomized.
These individuals will be immediately randomized into an immediate or a wait list control group.
The immediate will receive the wheelchair maintenance training program after completing the baseline questionnaires.
The wait list control group will wait approximately 6 months before receiving the independent maintenance training program.
|
Wheelchair Maintenance Training Program: WMTP training consists of three parts.
It starts with an overview of basic wheelchair maintenance items, continues with the second section discussing how to inspect the parts of a wheelchair and finishes with the third section discussing how to perform wheelchair maintenance on a wheelchair.
Throughout the course, there are videos and pictures demonstrating the activities discussed in the training program.
Participants will also be informed when a repair requires professional assistance and where such assistance may be found.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Wheelchair Maintenance Training Questionnaire (WMT-Q)
Time Frame: This measure is collected at baseline, pre- training, during the training, as well as at the 1 month and 6 month follow ups.
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The WMT-Q has three sub scales which measure of an individual's knowledge of maintenance (knowledge), their or their caregiver's ability to complete maintenance (capacity), and the frequency at which they or their caregiver perform it (performance).
Each subscale ranges from 0-100 with larger numbers indicating greater proficiency.
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This measure is collected at baseline, pre- training, during the training, as well as at the 1 month and 6 month follow ups.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Assistive Technology Module Questionnaire (ATM-Q)
Time Frame: This measure is collected at baseline, pre- training, and at the 6 month follow up.
|
This outcome measure collects information on the number of repairs an individual's wheelchair required as well as the incidence of subsequent consequences from the repair - stranded, injured, missed work or school, or missed a medical appointment.
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This measure is collected at baseline, pre- training, and at the 6 month follow up.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn Worobey, PhD, DPT, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY18100047
- 90SI5014-01-00 (Other Grant/Funding Number: U.S. Department of Health and Human Services)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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Clinical Trials on Wheelchair Maintenance Training
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