Wheelchair TransfersNCT03160612
Investigation of the Effects of Independent Transfer Training
A study testing Transfer Training in people with Wheelchair Transfers, run by University of Pittsburgh at 1 site in United States.
Trial summary
The objective of this research study is to 1) evaluate the effectiveness of web based transfer training materials for wheelchair users and 2) determine the reliability of a refined transfer assessment instrument (TAI) as completed by individuals who use wheelchairs for a majority of mobility and clinicians who score… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wheelchair Transfers
- What is being tested?
- Transfer Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 18 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15206
About this study
The objective of this research study is to 1) evaluate the effectiveness of web based transfer training materials for wheelchair users and 2) determine the reliability of a refined transfer assessment instrument (TAI) as completed by individuals who use wheelchairs for a majority of mobility and clinicians who score transfers in-person and remotely.
Read the 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.
- Conditions
- Wheelchair Transfers
- Being tested
- Transfer Training
- Keywords
- Wheelchair, Biomechanics, Transfer, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Case | Other | Transfer Training Subjects will be randomized to receive the transfer training either after baseline measures are collected (case) during visit 1. Receives: Behavioral: Transfer Training |
| Control | Other | Transfer Training Subjects will be randomized to receive the transfer training during the follow-up testing at visit 2. Receives: Behavioral: Transfer Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Transfer Assessment Instrument (TAI) Scores
Transfer assessment instrument (TAI) scores will be collected both before and after the training to assess for changes in the score.
Measured: Baseline visit and visit 2 (which will occur within 7 days of baseline)
Secondary outcomes (4)
Shoulder pain
A physical exam will be performed to qualify shoulder pain.
Measured: Baseline visit
Shoulder pathology
A physical exam will be performed to qualify shoulder pathology.
Measured: Baseline Visit
Wrist Pain
A physical exam will be performed to qualify wrist pain.
Measured: Baseline visit
Wrist pathology
A physical exam will be performed to qualify wrist pathology.
Measured: Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startJun 2015
- Primary completion2 Jul 2016
- Study completion18 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wheelchair TransfersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Michael Boninger, University of Pittsburgh
- Investigators
- Michael Boninger, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160612
- Sponsor's protocol ID
- 15030691
- Other IDs
- H133N110011
- Status last verified
- Jan 2025
- First submitted
- 16 May 2017
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Independent Transfer Training
- ClinicalTrials.gov ID
- NCT03160612
- Acronym / sponsor ID
- 15030691
- Conditions
- Wheelchair Transfers
- Keywords
- Wheelchair, Biomechanics, Transfer, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Jun 2015 (actual)
- Primary completion
- 2 Jul 2016 (actual)
- Study completion
- 18 Feb 2018 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research study is to 1) evaluate the effectiveness of web based transfer training materials for wheelchair users and 2) determine the reliability of a refined transfer assessment instrument (TAI) as completed by individuals who use wheelchairs for a majority of mobility and clinicians who score transfers in-person and remotely.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Other | Behavioral: Transfer TrainingTransfer Training Subjects will be randomized to receive the transfer training either after baseline measures are collected (case) during visit 1. |
| Control | Other | Behavioral: Transfer TrainingTransfer Training Subjects will be randomized to receive the transfer training during the follow-up testing at visit 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfer TrainingTransfer 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. | Behavioural | Case, Control |
Primary outcome
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.
4 secondary outcomes
Shoulder pain
Time frame: Baseline visit
Shoulder pathology
Time frame: Baseline Visit
Wrist Pain
Time frame: Baseline visit
Wrist pathology
Time frame: Baseline Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Boninger, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer Training in people with Wheelchair Transfers, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transfer Assessment Instrument (TAI) Scores (time frame: Baseline visit and visit 2 (which will occur within 7 days of baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.