- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160612
Investigation of the Effects of Independent Transfer Training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Up to 125 participants will be recruited for this study. Investigators will recruit individuals who use a wheelchair for a majority of mobility (>40 hours per week), who are over 18 years old, who do not have a history of heart or lung conditions that could become worse with up to 6 back and forth transfers to a mat table, and who can independently transfer to and from a surface within 30 seconds without use of their legs.
This study will require two visits that will take approximately 2 hours total to complete. Subjects will be asked to fill out a series of questionnaires so that investigators can collect demographic information (i.e. age, race, diagnosis, date of diagnosis, handedness, and preferred leading arm for transfers), their weight, and information about arm pain. Physical exams qualifying shoulder and wrist pathology will also be completed. Subjects will then be asked to perform up to six back and forth transfers to a mat table.
Following this, subjects will be randomized into two groups; one group that will receive transfer training immediately, and one group that will receive the transfer training after the follow up visit (control).
Subjects in the immediate transfer training group will receive training about about proper transfer techniques. After training, they will then complete the repeated transfer portion of the protocol a second time. Subjects will be instructed to practice the new skills they learned and then return within 7 days to complete only the repeated transfer portion of the protocol.
Subjects in the delayed transfer training group will be instructed to return within 7 days. Subjects will complete the repeated transfer portion of the protocol a second time. Subjects will then receive training about proper transfer techniques and after complete the repeated transfer portion of the protocol a third 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, 15206
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over the age of 18
- Utilizes a wheelchair for the majority of mobility (over 40 hours per week)
- Ability to transfer independently (may use equipment)
- Self-report ability to complete a transfer to and from a surface in 30 seconds
- English speaking
Exclusion Criteria:
- Current or recent history (last 3 months) of pressure sores that may be exacerbated by multiple transfers
- Active use of the lower limb muscles during transfers
- Upper extremity pain that inhibits the ability to perform transfers or bear weight on the upper extremities
- Other neurologic condition that could impair learning
- History of heart or lung conditions that would be made worse by completing up to six back and forth transfers to a mat table
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Case
Transfer Training Subjects will be randomized to receive the transfer training either after baseline measures are collected (case) during visit 1.
|
Transfer training interventions will take approximately 1 hour to complete and consist of an interactive web based module that participants interact with which includes text, pictures, videos and time to practice new skills.
Additionally, participants will receive an educational handout summarizing the online module.
|
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Other: Control
Transfer Training Subjects will be randomized to receive the transfer training during the follow-up testing at visit 2.
|
Transfer training interventions will take approximately 1 hour to complete and consist of an interactive web based module that participants interact with which includes text, pictures, videos and time to practice new skills.
Additionally, participants will receive an educational handout summarizing the online module.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Transfer Assessment Instrument (TAI) Scores
Time Frame: Baseline visit and visit 2 (which will occur within 7 days of baseline)
|
Transfer assessment instrument (TAI) scores will be collected both before and after the training to assess for changes in the score.
|
Baseline visit and visit 2 (which will occur within 7 days of baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder pain
Time Frame: Baseline visit
|
A physical exam will be performed to qualify shoulder pain.
|
Baseline visit
|
|
Shoulder pathology
Time Frame: Baseline Visit
|
A physical exam will be performed to qualify shoulder pathology.
|
Baseline Visit
|
|
Wrist Pain
Time Frame: Baseline visit
|
A physical exam will be performed to qualify wrist pain.
|
Baseline visit
|
|
Wrist pathology
Time Frame: Baseline Visit
|
A physical exam will be performed to qualify wrist pathology.
|
Baseline Visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Boninger, M.D., 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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15030691
- H133N110011 (Other Grant/Funding Number: U.S. Department of Education)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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