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Clinical Trials/NCT03164278
NCT03164278
Active, not recruiting
Not Applicable

Studying the Effectiveness of Remote Training

University of Pittsburgh1 site in 1 country200 target enrollmentDecember 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Remote Transfer Training Program
Sponsor
University of Pittsburgh
Enrollment
200
Locations
1
Primary Endpoint
Change in Transfer Assessment Instrument Questionnaires (TAI-Q)
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

The objective of this research study is to assess the effectiveness of an independent transfer training program (ITTP), and to determine methods which may increase overall success of an online training program.

Detailed Description

Up to 200 individuals will be recruited for this research study. Investigators will recruit individuals who use a wheelchair for the majority of their mobility (over 40 hours per week), have the ability to transfer independently (may use equipment like sliding boards), use a seated pivot to transfer, and speak English as a primary a language. This study will be accessed entirely online and participation is expected to last approximately one year. Subjects will be randomized into three groups; one group that will receive transfer training immediately with no follow up, one group that will receive the transfer training immediately with 1 month and 6 month follow up, and one group that will receive the transfer training after 6 months. The transfer training program itself will take approximately 1 hour to complete. After obtaining informed consent, participants in the first two groups will complete baseline questionnaires. They will then receive the transfer 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 transfer assessment instrument questionnaire. They will then wait 5 months. After this period, participants will complete the baseline questionnaires a second time, and then receive the transfer training. After completing the transfer training, all groups will be contacted immediately post training to complete additional questionnaires to assess the effectiveness of the remote transfer training program. Participants in the 2nd and 3rd group will be contacted 1 month and 6 months post-training to complete additional questionnaires.

Registry
clinicaltrials.gov
Start Date
December 4, 2017
End Date
December 1, 2027
Last Updated
4 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Boninger

Professor and UPMC Endowed Vice Chair for Research

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Utilize a wheelchair for the majority of mobility (over 40 hours per week).
  • Ability to transfer independently (may use equipment like sliding boards).
  • Use of seated pivot transfer
  • Speak English as a primary a language

Exclusion Criteria

  • Pain prohibiting transfers
  • Active use of the lower limb muscles during transfers
  • Current or recent history (last 3 months) of pressure sores

Outcomes

Primary Outcomes

Change in Transfer Assessment Instrument Questionnaires (TAI-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.

We will assess the mathematical difference in assessments from baseline to follow-up.

Secondary Outcomes

  • Change in Patient Reported Outcomes Measurement Information System: Physical Function with Mobility Aid(This measure is collected pre-training and at the 6 month follow up.)
  • Change in Wheelchair Users Shoulder Pain Index (WUSPI)(This measure is collected pre- training, as well as at 6 month follow up.)
  • Change in Patient Reported Outcomes Measurement Information System: Satisfaction with Social Roles & Activities(This measure is collected pre-training and at the 6 month follow up.)
  • Change in Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities(This measure is collected pre-training and at the 6 month follow up.)

Study Sites (1)

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