Wheelchair UsersPhase 2NCT00283296
Development of a Collapsible Folding Manual Wheelchair
A Phase 2 study testing Endeavor in people with Wheelchair Users, run by VA Pittsburgh Healthcare System at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wheelchair Users
- What is being tested?
- Endeavor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Apr 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Use a manual wheelchair as a primary means of mobility.
- Male and females over the age of 18.
- The ability to adequately fit in a wheelchair with a 16" seat width.
- A minimum of 6 months experience using a manual wheelchair as primary means of mobility.
- Able to transfer independently.
- Drive own vehicle from vehicle seat.
Who cannot join
- Active pressure sores as reported by subject.
- History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual wheelchair.
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, 15206
About this study
The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.
Read the detailed description
The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.
There are two stages to this research project: an Activities of Daily Living Course and an In-Home trial. The activities of daily living course is located at the Human Engineering Research Laboratories and simulates daily barriers encountered by wheelchair users. Subjects will be asked to complete the course in their personal wheelchair and in the Endeavor three times each. Testing will be completed during a one-day visit that will not exceed 2 1/2 hours.
For the in-home trial, subjects will be asked to use the Endeavor as their primary means of mobility for two weeks, which will be compared to using their own wheelchair for two weeks. During this four-week period a datalogger will be mounted to the subject's wheelchair(s), which will give information about distance traveled, average speed, and time used. In addition to the data-logger, subjects will also be asked to keep a brief, daily, written log of the activities they performed while in the chair. At the end of the Endeavor trial-use period, subjects will be asked to complete a questionnaire. There is an 8-week follow-up period where subjects will be allowed to keep the Endeavor. We will make three calls during this period to conduct interviews on usage of the Endeavor.
- Conditions
- Wheelchair Users
- Being tested
- Endeavor
- Keywords
- manual wheelchair, assistive technology, travel wheelchair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndeavorDevice
Collapsible, forward folding manual wheelchair
| Study group | Role | What they receive |
|---|---|---|
| Endeavor Wheelchair | Experimental | Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair. Receives: Device: Endeavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle
Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.
Measured: immediately following course completion
Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)
Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.
Measured: 2 week in-home trial
Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)
Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.
Measured: 2 week in-home trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJan 2004
- Primary completionJul 2008
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wheelchair UsersStudies of the same condition, open and under way.
- 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pittsburgh Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Rory Cooper, VA Pittsburgh Healthcare System
- Investigators
- Rory A Cooper, PhD, Principal investigator, Human Engineering Research Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283296
- Sponsor's protocol ID
- 02331, 0408063
- Other IDs
- H133S030016
- Status last verified
- Dec 2014
- First submitted
- 24 Jan 2006
- Last updated
- 6 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Collapsible Folding Manual Wheelchair
- ClinicalTrials.gov ID
- NCT00283296
- Acronym / sponsor ID
- 02331, 0408063
- Conditions
- Wheelchair Users
- Keywords
- manual wheelchair, assistive technology, travel wheelchair
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- VA Pittsburgh Healthcare SystemUS federal agency
- Study start
- Jan 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Jan 2006 (estimated)
- Results
- Posted 6 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.
Detailed description
The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.
There are two stages to this research project: an Activities of Daily Living Course and an In-Home trial. The activities of daily living course is located at the Human Engineering Research Laboratories and simulates daily barriers encountered by wheelchair users. Subjects will be asked to complete the course in their personal wheelchair and in the Endeavor three times each. Testing will be completed during a one-day visit that will not exceed 2 1/2 hours.
For the in-home trial, subjects will be asked to use the Endeavor as their primary means of mobility for two weeks, which will be compared to using their own wheelchair for two weeks. During this four-week period a datalogger will be mounted to the subject's wheelchair(s), which will give information about distance traveled, average speed, and time used. In addition to the data-logger, subjects will also be asked to keep a brief, daily, written log of the activities they performed while in the chair. At the end of the Endeavor trial-use period, subjects will be asked to complete a questionnaire. There is an 8-week follow-up period where subjects will be allowed to keep the Endeavor. We will make three calls during this period to conduct interviews on usage of the Endeavor.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endeavor Wheelchair | Experimental | Device: EndeavorParticipants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Use a manual wheelchair as a primary means of mobility.
- Male and females over the age of 18.
- The ability to adequately fit in a wheelchair with a 16" seat width.
- A minimum of 6 months experience using a manual wheelchair as primary means of mobility.
- Able to transfer independently.
Key exclusion criteria (2 listed)
- Active pressure sores as reported by subject.
- History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual 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 |
|---|---|---|
| EndeavorCollapsible, forward folding manual wheelchair | Device | Endeavor Wheelchair |
Primary outcome
Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle
Time frame: immediately following course completion
Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle.
Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)
Time frame: 2 week in-home trial
Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.
Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)
Time frame: 2 week in-home trial
Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Wheelchair Users
Recruiting
Cardiometabolic Health Intervention Using Movement-to-Music Exercise
Cardiometabolic Risk Factors in Adult Wheelchair Users
Not yet recruitingObservational study
New Rear Anti-tip Device for Manual Wheelchairs: Subjective Input (RAD-SI)
Wheelchair Users, Caregivers
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.
Rory A Cooper, PhD principal investigator
Human Engineering Research Laboratories
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endeavor in people with Wheelchair Users, run by VA Pittsburgh Healthcare System 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 6 inclusion and 2 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 6 Jan 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle (time frame: immediately following course completion). The study lists 3 primary outcomes in all. 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 6 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.