NCT00333762

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

December 3, 2015

Completed
Last Updated

December 3, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

June 2, 2006

Results QC Date

September 24, 2013

Last Update Submit

October 30, 2015

Conditions

Keywords

agingblindnesswheelchairsspinal cord injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two years

Study Arms (1)

SPAM and SWCS

EXPERIMENTAL

Smart Power Assistance Module (SPAM) Smart Wheelchair Component System (SWCS)

Device: Smart Power Assistance Module (SPAM)Device: Smart Wheelchair Component System (SWCS)

Interventions

Experimental Power wheelchair utilized to traverse prescribed course

SPAM and SWCS

Experimental power wheelchair utilized to traverse prescribed course

SPAM and SWCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mobility impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Links

MeSH Terms

Conditions

BlindnessSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Limitations and Caveats

Only four subjects actually tested the chair. It was decided to stop after these four subject tests because the chairs were clearly not viable for this population of persons who were totally blind, and thus there was no need for further testing.

Results Point of Contact

Title
Dana Sinciline
Organization
VA Pittsburgh Healthcare System

Study Officials

  • Richard Simpson, PhD

    VAPHS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 3, 2015

Results First Posted

December 3, 2015

Record last verified: 2015-10

Locations