- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00981344
Wheeled Mobility in Everyday Life (RERC-4a)
Wheeled Mobility in Everyday Life: Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Durham, North Carolina, United States, 27703
- Duke University Medical Center
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Durham, North Carolina, United States, 27705
- Durham VA Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Speed (in meters/second)
Time Frame: trial duration (generally 1 to 20 minutes)
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trial duration (generally 1 to 20 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self Report of exertion, pain, fatigue,and device preference
Time Frame: completion of study (generally 20 to 40 minutes)
|
completion of study (generally 20 to 40 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helen Hoenig, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00012299
- NIDRR, H133E80003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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