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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03164278
Other study ID # STUDY19020341
Secondary ID 90SI5014-01-00
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 4, 2017
Est. completion date June 1, 2026

Study information

Verified date February 2024
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date June 1, 2026
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Utilize a wheelchair for the majority of mobility (over 40 hours per week). 2. Ability to transfer independently (may use equipment like sliding boards). 3. Use of seated pivot transfer 4. Speak English as a primary a language Exclusion Criteria: 1. Pain prohibiting transfers 2. Active use of the lower limb muscles during transfers 3. Current or recent history (last 3 months) of pressure sores

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Independent Transfer Training
Independent Transfer Training Program: ITTP training starts with an overview and self-evaluation using the transfer assessment instrument questionnaire (TAI-Q) followed by three core modules: wheelchair setup, body setup, and flight/landing. Wheelchair setup includes factors such as the angle and distance of the wheelchair to the transfer surface, removing barriers, applying the brakes, and height of the transfer. Body setup involves positioning one's body for an optimal transfer and covers foot, hip, arm and hand positions. Flight/landing discusses how to achieve a smooth and controlled transfer, the head-hips relationship, use of transfer device, and safe landing.

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Transfer Assessment Instrument Questionnaires (TAI-Q) We will assess the mathematical difference in assessments from baseline to follow-up. This measure is collected at baseline, pre- training, during the training, as well as at the 1 month and 6 month follow ups.
Secondary Change in Wheelchair Users Shoulder Pain Index (WUSPI) We will assess the mathematical difference in assessments from baseline to follow-up. This measure is collected pre- training, as well as at 6 month follow up.
Secondary Change in Patient Reported Outcomes Measurement Information System: Physical Function with Mobility Aid We will assess the mathematical difference in assessments from baseline to follow-up. This measure is collected pre-training and at the 6 month follow up.
Secondary Change in Patient Reported Outcomes Measurement Information System: Satisfaction with Social Roles & Activities We will assess the mathematical difference in assessments from baseline to follow-up. This measure is collected pre-training and at the 6 month follow up.
Secondary Change in Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities We will assess the mathematical difference in assessments from baseline to follow-up. This measure is collected pre-training and at the 6 month follow up.