Wheeled Mobility in Everyday Life
RERC-4a
2 other identifiers
interventional
59
1 country
2
Brief Summary
The project will examine how mobility performance in real life tasks and environments is impacted by the use of specific types of wheeled mobility devices (wheeled walker, manual wheelchair, power wheelchair/scooter). Specifically, the project will: 1) randomly recruit persons who were prescribed a mobility aid within the preceding 1 year and currently use the mobility aid, 2) define key mobility tasks within a public environment, 3) measure mobility performance of subjects as they perform the mobility tasks in each of the four devices, and 4) synthesize and disseminate the results. Study results will be used to establish baseline performance data for researchers and clinicians and to identify design improvements for wheelchairs used by community dwelling elders. All study participants will be required to complete study related questionnaires about their family environment and familiarity with the various types of mobility aids. In addition, physical abilities will be measured at the start of the study, including measures of arm and leg strength, and the ability to walk and push a wheelchair. This will take about 30 minutes. A total of 150 subjects will be recruited among Veterans prescribed mobility aids in the preceding 3-12 months identified through administrative data sources. The mobility aids being studied are all standard types of mobility aids used by people with limited mobility (e.g., wheeled walker, manual wheelchair, power wheelchair/scooter). Analyses will proceed in a stepwise fashion. The first step will be to examine the primary study question relating device type to the dependent variable, with velocity being the primary outcome. The next step in the analysis will be to determine if there is an interaction between medical condition, mobility devices, and the dependent variable. Finally, exploratory analyses will be carried out to examine the relationship between baseline measures of physical function and mobility performance with each of the devices. Study related risks are minimal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 15, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 9, 2012
August 1, 2012
3.8 years
September 15, 2009
November 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Speed (in meters/second)
trial duration (generally 1 to 20 minutes)
Secondary Outcomes (1)
Self Report of exertion, pain, fatigue,and device preference
completion of study (generally 20 to 40 minutes)
Interventions
We are studying how wheeled mobility performance and the impact of device type on a group of community dwelling Veterans.
Eligibility Criteria
You may qualify if:
- Prescribed wheeled walker, manual wheelchair, power mobility device in last 3-12 months
- Have chronic heart (e.g., congestive heart failure) or lung disorder (e.g., chronic obstructive pulmonary disease), and/or arthritic disorder (e.g., osteoarthritis)
- Reports using wheeled walker, manual wheelchair, or power mobility device in the preceding 2 weeks
You may not qualify if:
- Reports missing one or more limbs and/or complete paralysis of one or more limbs
- Have a neurological, myopathic, or cognitive disorder
- Weight more than 300 lbs; height more than 74 inches
- Poorly controlled hypertension, unstable angina, a heart attack or heart surgery within the last 6 months.
- Reports any of the following: Does not have an active Drivers License, unable to walk across small room without human help, unable to propel w/ch across small room without human help (applies only to those already using a manual w/ch), needs moderate assistance from another person to transfer, unable to sit on side of bed independently, currently has shoulder pain with self care or with wheelchair use.
- Major surgery affecting abdominal, chest, spine, upper extremity in the last 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (2)
Duke University Medical Center
Durham, North Carolina, 27703, United States
Durham VA Hospital
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Hoenig, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2009
First Posted
September 22, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 9, 2012
Record last verified: 2012-08