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
  Purpose

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.


Condition Intervention
Wheelchair Users
Device: Pushrim Activated Power Assist

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia

Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: November 2001
Study Completion Date: January 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00281463

Locations
United States, Pennsylvania
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
VA Pittsburgh Healthcare System
Investigators
Principal Investigator: Rory A Cooper, PhD Human Engineering Research Laboratories
  More Information

Additional Information:
No publications provided

Responsible Party: Rory Cooper, Director; Pittsburgh VA Rehabilitation Research & Development Center, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT00281463     History of Changes
Other Study ID Numbers: 01103, 010842, H133N000019
Study First Received: January 23, 2006
Last Updated: February 28, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:
wheelchair
spinal cord injury
rehabilitation

Additional relevant MeSH terms:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014