NCT00981344

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 9, 2012

Status Verified

August 1, 2012

Enrollment Period

3.8 years

First QC Date

September 15, 2009

Last Update Submit

November 7, 2012

Conditions

Keywords

wheelchairmobility disabilityevidence based practiceself help devicesVeterans prescribed mobility aids

Outcome Measures

Primary Outcomes (1)

  • Speed (in meters/second)

    trial duration (generally 1 to 20 minutes)

Secondary Outcomes (1)

  • Self Report of exertion, pain, fatigue,and device preference

    completion of study (generally 20 to 40 minutes)

Interventions

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

Also known as: RERC-4a, Wheeled Mobility in Everyday Life

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Durham VA Hospital

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Lung DiseasesArthritis

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Helen Hoenig, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 22, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 9, 2012

Record last verified: 2012-08

Locations