Wheelchair Maintenance Training Program

November 8, 2024 updated by: Lynn Worobey, University of Pittsburgh

Effectiveness of a Remote Wheelchair Maintenance Training Program

The objective of this research study is to assess the effectiveness of a remote wheelchair maintenance training program, and to determine methods which may increase overall success of an online training program.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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).
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.
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.
This measure is collected at baseline, pre- training, during the training, as well as at the 1 month and 6 month follow ups.

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.
This measure is collected at baseline, pre- training, and at the 6 month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lynn Worobey, PhD, DPT, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

August 10, 2023

Study Completion (Actual)

August 10, 2023

Study Registration Dates

First Submitted

April 7, 2019

First Submitted That Met QC Criteria

April 7, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 8, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

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)?

YES

IPD Plan Description

De-identified data may be shared with other investigators.

IPD Sharing Time Frame

Information will be shared throughout duration of collaboration.

IPD Sharing Access Criteria

A request will be made to the Principal Investigator, who will consider the request. No identifiable information will be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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