Wheeled Mobility in Everyday Life (RERC-4a)

November 7, 2012 updated by: Duke University

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

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27703
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27705
        • Durham VA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Helen Hoenig, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 15, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

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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