BlindnessNCT00333762
Use of "Smart Wheelchairs" to Provide Independent Mobility to Visual and Mobility Impairments
A study testing Smart Power Assistance Module (SPAM) and Smart Wheelchair Component System (SWCS) in people with Blindness and Spinal Cord Injury, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blindness, Spinal Cord Injury
- What is being tested?
- Smart Power Assistance Module (SPAM) and Smart Wheelchair Component System (SWCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to May 2008
- Phase
- Interventional
- 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
- All participants will be completely blind
- Participants will be able to operate a power wheelchair with joystick control
- Participants will be able to push a manual wheelchair a minimum of 300 yards
Who cannot join
- Mobility impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (but do not have a mobility impairment) with several single-case studio involving individuals who have a visual and mobility impairment. Our long-term objective is to provide independent mobility to veterans with mobility and sensory impairments.
Read the detailed description
There are currently very few mobility options for veterans who have a mobility impairment and visual impairment, and this population will grow as the number of older veteran's increases. The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (and may or may not have a mobility impairment) with several single-case studies involving individuals who have a visual and mobility impairment.
The key questions that will be addresses by the proposed research are:
Can smart wheelchair technology improve performance on realistic navigation tasks for individuals with visual and mobility impairments?
Will smart wheelchair technology increase the amount of independent travel by individuals with visual and mobility impairments?
Will using a smart wheelchair for an extended period of time diminish a person's ability to operate a "traditional" wheeled mobility aid?
- Conditions
- Blindness, Spinal Cord Injury
- Being tested
- Smart Power Assistance Module (SPAM), Smart Wheelchair Component System (SWCS)
- Keywords
- aging, blindness, wheelchairs, spinal cord injury
- Medical subject headings
- Blindness, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Power Assistance Module (SPAM)Device
Experimental Power wheelchair utilized to traverse prescribed course
Smart Wheelchair Component System (SWCS)Device
Experimental power wheelchair utilized to traverse prescribed course
| Study group | Role | What they receive |
|---|---|---|
| SPAM and SWCS | Experimental | Smart Power Assistance Module (SPAM) Smart Wheelchair Component System (SWCS) Receives: Device: Smart Power Assistance Module (SPAM); Device: Smart Wheelchair Component System (SWCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Trial Wheelchair Course
Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2008
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 BlindnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard Simpson, PhD, Principal investigator, VAPHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333762
- Sponsor's protocol ID
- B4065-X
- Status last verified
- Oct 2015
- First submitted
- 2 Jun 2006
- Last updated
- 3 Dec 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 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of "Smart Wheelchairs" to Provide Independent Mobility to Visual and Mobility Impairments
- ClinicalTrials.gov ID
- NCT00333762
- Acronym / sponsor ID
- B4065-X
- Conditions
- Blindness, Spinal Cord Injury
- Keywords
- aging, blindness, wheelchairs, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Posted 3 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (but do not have a mobility impairment) with several single-case studio involving individuals who have a visual and mobility impairment. Our long-term objective is to provide independent mobility to veterans with mobility and sensory impairments.
Detailed description
There are currently very few mobility options for veterans who have a mobility impairment and visual impairment, and this population will grow as the number of older veteran's increases. The goal of this project is to evaluate the Smart Wheelchair Component System (SWCS) for power wheelchairs and the Smart Power Assistance Module (SPAM) for manual wheelchairs in realistic indoor environments with target users performing realistic tasks. We will combine group trials involving individuals who have a visual impairment (and may or may not have a mobility impairment) with several single-case studies involving individuals who have a visual and mobility impairment.
The key questions that will be addresses by the proposed research are:
Can smart wheelchair technology improve performance on realistic navigation tasks for individuals with visual and mobility impairments?
Will smart wheelchair technology increase the amount of independent travel by individuals with visual and mobility impairments?
Will using a smart wheelchair for an extended period of time diminish a person's ability to operate a "traditional" wheeled mobility aid?
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPAM and SWCS | Experimental | Device: Smart Power Assistance Module (SPAM), Device: Smart Wheelchair Component System (SWCS)Smart Power Assistance Module (SPAM) Smart Wheelchair Component System (SWCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants will be completely blind
- Participants will be able to operate a power wheelchair with joystick control
- Participants will be able to push a manual wheelchair a minimum of 300 yards
Key exclusion criteria (1 listed)
- Mobility impairment
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 |
|---|---|---|
| Smart Power Assistance Module (SPAM)Experimental Power wheelchair utilized to traverse prescribed course | Device | SPAM and SWCS |
| Smart Wheelchair Component System (SWCS)Experimental power wheelchair utilized to traverse prescribed course | Device | SPAM and SWCS |
Primary outcome
Time to Complete Trial Wheelchair Course
Time frame: Two years
Time to complete the course was recorded. The indoor course was set up in the research laboratory to include a straight path and 90 degree turns that included obstacles such as a cardboard box, a large orange cone, and a desk chair. The location of these obstacles were randomly placed in order to test whether or not the SPAM or SWCS was able to detect objects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: Use of "Smart Wheelchairs" to Provide Independent Mobility to Visual and Mobility ImpairmentsLink provided by the sponsor.
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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.
Richard Simpson, PhD principal investigator
VAPHS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Power Assistance Module (SPAM) and Smart Wheelchair Component System (SWCS) in people with Blindness and Spinal Cord Injury, run by VA Office of Research and Development at 2 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 3 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 3 Dec 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?
Time to Complete Trial Wheelchair Course (time frame: Two years). 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 3 Dec 2015.