Wheeled Mobility in Everyday Life

Arthritis Clinical Trial

— RERC-4a  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981344
• Other study ID #: Pro00012299
• Secondary ID: NIDRR, H133E8000
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: November 7, 2012
• Start date: October 2008
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Chronic Heart Disorder
• Disease
• Heart Diseases
• Lung Diseases
• Lung Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham VA Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed (in meters/second)		trial duration (generally 1 to 20 minutes)	No
Secondary	Self Report of exertion, pain, fatigue,and device preference		completion of study (generally 20 to 40 minutes)	No