Spinal Cord InjuriesNCT03499951
Remote Wheelchair Skills Training Efficacy
A study testing Wheelchair Skills Training - Remote and Wheelchair Skills Training - In Person in people with Spinal Cord Injuries, run by University of Pittsburgh at 4 sites in United States.
Trial summary
The objective of the study is to evaluate the effectiveness of remote training to teach clinicians how to train others in wheelchair skills. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Wheelchair Skills Training - Remote and Wheelchair Skills Training - In Person
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 May 2018to 4 Oct 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 75
Who cannot join
- Upper or lower extremity injury that would preclude the ability to use a wheelchair.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Midwest Regional Spinal Cord Injury Care System
Chicago, Illinois, 60611
South Florida Spinal Cord Injury System
Miami, Florida, 33136
University of Pittsburgh Model Center on Spinal Cord Injury
Pittsburgh, Pennsylvania, 15219
Northern New Jersey Spinal Cord System
West Orange, New Jersey, 07052
About this study
Official title: Remote Wheelchair Skills Training Efficacy Coordinating Center
The objective of the study is to evaluate the effectiveness of remote training to teach clinicians how to train others in wheelchair skills.
- Conditions
- Spinal Cord Injuries
- Being tested
- Wheelchair Skills Training - Remote, Wheelchair Skills Training - In Person
- Keywords
- Quality of life, Participation, Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair Skills Training - RemoteBehavioural
Individuals will receive wheelchair skills training remotely. They will be provided with the Wheelchair Skills Training Program to review (http://www.wheelchairskillsprogram.ca/eng/index.php), and then will be directed to use this information to perform the wheelchair skills. They will video the attempts, and will receive feedback on methods to improve their techniques.
Wheelchair Skills Training - In PersonBehavioural
Individuals will receive wheelchair skills training in one-on-one sessions, taught by those who received the wheelchair skills training remotely.
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair Skills Trainers | Other | Individuals will receive remotely delivered wheelchair skills training, after which they will be assessed on their ability to teach the Wheelchair Skills Trainees a series of wheelchair skills in a one-on-one environment. The intervention for this group is Wheelchair Skills Training - Remote. Receives: Behavioral: Wheelchair Skills Training - Remote |
| Wheelchair Skills Trainees | Other | Individuals will receive one-on-one wheelchair skills training from the Wheelchair Skills Trainers. The intervention for this group is Wheelchair Skills Training - In Person. Receives: Behavioral: Wheelchair Skills Training - In Person |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in wheelchair skills capacity of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire
Trainees will have increased capacity to perform wheelchair skills after receiving one-on-one skills training.
Measured: Baseline, and at study completion ( an average of 3 weeks)
Change from baseline in wheelchair skills confidence of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire
Trainees will have increased confidence in their ability to perform wheelchair skills after receiving one-on-one skills training.
Measured: Baseline, and at study completion ( an average of 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start25 May 2018
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- 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
- NCT03499951
- Sponsor's protocol ID
- PRO18010289
- Status last verified
- Jul 2022
- First submitted
- 19 Mar 2018
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD outside of collaborators.
Publications
Worobey LA, Kirby RL, Cowan RE, Dyson-Hudson TA, Shea M, Heinemann AW, Pedersen JP, Boninger ML. Efficacy of a Remote Train-the-Trainer Model for Wheelchair Skills Training Administered by Clinicians: A Cohort Study With Pre- vs Posttraining Comparisons. Arch Phys Med Rehabil. 2022 Apr;103(4):798-806. doi: 10.1016/j.apmr.2021.03.042. Epub 2021 Jun 6.
PubMed 34090853
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Wheelchair Skills Training Efficacy Coordinating Center
- ClinicalTrials.gov ID
- NCT03499951
- Acronym / sponsor ID
- PRO18010289
- Conditions
- Spinal Cord Injuries
- Keywords
- Quality of life, Participation, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 25 May 2018 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 17 Apr 2018 (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 the study is to evaluate the effectiveness of remote training to teach clinicians how to train others in wheelchair skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair Skills Trainers | Other | Behavioral: Wheelchair Skills Training - RemoteIndividuals will receive remotely delivered wheelchair skills training, after which they will be assessed on their ability to teach the Wheelchair Skills Trainees a series of wheelchair skills in a one-on-one environment. The intervention for this group is Wheelchair Skills Training - Remote. |
| Wheelchair Skills Trainees | Other | Behavioral: Wheelchair Skills Training - In PersonIndividuals will receive one-on-one wheelchair skills training from the Wheelchair Skills Trainers. The intervention for this group is Wheelchair Skills Training - In Person. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 to 75
Key exclusion criteria (1 listed)
- Upper or lower extremity injury that would preclude the ability to use a wheelchair.
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 |
|---|---|---|
| Wheelchair Skills Training - RemoteIndividuals will receive wheelchair skills training remotely. They will be provided with the Wheelchair Skills Training Program to review (http://www.wheelchairskillsprogram.ca/eng/index.php), and then will be directed to use this information to perform the wheelchair skills. They will video the attempts, and will receive feedback on methods to improve their techniques. | Behavioural | Wheelchair Skills Trainers |
| Wheelchair Skills Training - In PersonIndividuals will receive wheelchair skills training in one-on-one sessions, taught by those who received the wheelchair skills training remotely. | Behavioural | Wheelchair Skills Trainees |
Primary outcome
Change from baseline in wheelchair skills capacity of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire
Time frame: Baseline, and at study completion ( an average of 3 weeks)
Trainees will have increased capacity to perform wheelchair skills after receiving one-on-one skills training.
Change from baseline in wheelchair skills confidence of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire
Time frame: Baseline, and at study completion ( an average of 3 weeks)
Trainees will have increased confidence in their ability to perform wheelchair skills after receiving one-on-one skills training.
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 29 Jul 2022.
- Derived from this study: PubMed 34090853Worobey LA, Kirby RL, Cowan RE, Dyson-Hudson TA, Shea M, Heinemann AW, Pedersen JP, Boninger ML. Efficacy of a Remote Train-the-Trainer Model for Wheelchair Skills Training Administered by Clinicians: A Cohort Study With Pre- vs Posttraining Comparisons. Arch Phys Med Rehabil. 2022 Apr;103(4):798-806. doi: 10.1016/j.apmr.2021.03.042. Epub 2021 Jun 6.
- Individual participant dataSharing planned: No. There is no plan to share IPD outside of collaborators.
Related trials for Spinal Cord Injuries
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tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
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Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
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Recruiting
Neuromodulation for Metabolic Dysfunction
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair Skills Training - Remote and Wheelchair Skills Training - In Person in people with Spinal Cord Injuries, run by University of Pittsburgh at 4 sites 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 1 inclusion and 1 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 from baseline in wheelchair skills capacity of trainees at study completion as measured by the Wheelchair Skills Test Questionnaire (time frame: Baseline, and at study completion ( an average of 3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499951, which also lists 1 linked publication.
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 29 Jul 2022.