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Completed

NCT Number: NCT00981344

Wheeled Mobility in Everyday Life

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments

Other

We are studying how wheeled mobility performance and the impact of device type on a group of community dwelling Veterans.

Other names: RERC-4a, Wheeled Mobility in Everyday Life

Primary outcomes

  1. Speed (in meters/second)

    Time frame: trial duration (generally 1 to 20 minutes)

Secondary outcomes

  1. Self Report of exertion, pain, fatigue,and device preference

    Time frame: completion of study (generally 20 to 40 minutes)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Wheeled Mobility in Everyday Life: Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments

Acronym: RERC-4a

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2009
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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