Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rory Cooper, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:
NCT00281463
First received: January 23, 2006
Last updated: February 28, 2013
Last verified: February 2013

January 23, 2006
February 28, 2013
November 2001
March 2007   (final data collection date for primary outcome measure)
metabolic energy expenditures, stroke frequency, upper extremity joint range of motion, participant responses to a visual analog survey, average speed, and actual daily driving time spent in either wheelchair, and daily distance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
metabolic energy expenditures, stroke frequency, upper extremity joint range of motion, participant responses to a visual analog survey, average speed, and actual daily driving time spent in either wheelchair, and daily distan
Complete list of historical versions of study NCT00281463 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia

The purpose of this three phase study is to evaluate a Pushrim Activated Power Assist Wheelchair (PAPAW). Phase I will examine whether the steady-state, metabolic energy efficiency for propelling a manual wheelchair with and without the device will be significantly different. In Phase II, wheelchair users will evaluate the PAPAW over activities of daily living course to determine its usability and acceptability and to identify areas for future development. Finally, in phase III, comparison of activities of daily living in the community will be made between the subjects when using their personal wheelchair and a PAPAW.

Objectives:

The purpose of this three phase study is to evaluate a Pushrim Activated Power Assist Wheelchair (PAPAW). Phase I will examine whether the steady-state, metabolic energy efficiency for propelling a manual wheelchair with and without the device will be significantly different. In Phase II, wheelchair users will evaluate the PAPAW over activities of daily living course to determine its usability and acceptability and to identify areas for future development. Finally, in phase III, comparison of activities of daily living in the community will be made between the subjects when using their personal wheelchair and a PAPAW.

Research Design:

This is a repeated measures design type study, conducted in different locations for each phase: a biomechanics laboratory, an ADL driving course, and the participants' home environment. Analyzed variables include: metabolic energy expenditures, stroke frequency, upper extremity joint range of motion, participant responses to a visual analog survey, average speed, and actual daily driving time spent in either wheelchair, and daily distance traveled. Subjects will act as their own controls.

Methodology:

Full-time wheelchair users with tetraplegia between the ages of 18 and 65 will be recruited for the study. They will be free of pressure sores, free from any shoulder pain that would prevent them from propelling a manual wheelchair, and have no history of cardiopulmonary disease. A maximum of 50 subjects (fifteen for Phase I and II, and 15 or Phase III, and five for subject drop-out) will be recruited. In Phase I, participants will be asked to propel a PAPAW and their own wheelchair, attached to a wheelchair roller system through three resistance conditions. In Phase II, participants will be asked to propel both wheelchairs over activities of daily living. Finally, Phase III consists of a four-week trial including a two-week test with subjects' own wheelchairs (i.e. own chair trial) and a two-week test where they were provided with the PAPAW (i.e. PAPAW trial). The order of the own chair trial and the PAPAW trial will be randomized.

Clinical Relationship:

For individuals with tetraplegia, PAPAWs reduce energy demands, stroke frequency, and overall joint range of motion when compared to traditional manual wheelchair propulsion. In addition, PAPAWs have the potential to improve the functional capabilities during certain activities of daily living as well as community participation of individuals with tetraplegia. Use of this device could help maintain overall physical capacity while reducing the risk for pain and injuries to the upper extremities.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Wheelchair Users
Device: Pushrim Activated Power Assist
The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation).
Experimental: Pushrim Activated Power Assist Wheelchair
Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Intervention: Device: Pushrim Activated Power Assist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
January 2008
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 and 65 years of age
  • Full time wheelchair user
  • Diagnosis of Tetraplegia

Exclusion Criteria:

  • Pressure sores
  • Shoulder pain that would prevent them from propelling a manual wheelchair
  • History of cardiopulmonary disease.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00281463
01103, 010842, H133N000019
No
Rory Cooper, VA Pittsburgh Healthcare System
VA Pittsburgh Healthcare System
Not Provided
Principal Investigator: Rory A Cooper, PhD Human Engineering Research Laboratories
VA Pittsburgh Healthcare System
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP