Wheeled Mobility in Everyday Life (RERC-4a)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00981344
First received: September 15, 2009
Last updated: November 7, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Chronic Heart Disorder
Lung Disorder
Arthritis
Other: Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Wheeled Mobility in Everyday Life: Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Speed (in meters/second) [ Time Frame: trial duration (generally 1 to 20 minutes) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self Report of exertion, pain, fatigue,and device preference [ Time Frame: completion of study (generally 20 to 40 minutes) ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: October 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments
    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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981344

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27703
Durham VA Hospital
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Helen Hoenig, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00981344     History of Changes
Other Study ID Numbers: Pro00012299, NIDRR, H133E80003
Study First Received: September 15, 2009
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
wheelchair
mobility disability
evidence based practice
self help devices
Veterans prescribed mobility aids

Additional relevant MeSH terms:
Arthritis
Heart Diseases
Lung Diseases
Joint Diseases
Musculoskeletal Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014