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: November 6, 2014
Last verified: November 2014
Results First Received: November 6, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Wheelchair Users
Intervention: Device: Pushrim Activated Power Assist

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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).


Participant Flow:   Overall Study
    Pushrim Activated Power Assist Wheelchair  
STARTED     45  
COMPLETED     45  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

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).


Baseline Measures
    Pushrim Activated Power Assist Wheelchair  
Number of Participants  
[units: participants]
  45  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     45  
>=65 years     0  
Gender  
[units: participants]
 
Female     10  
Male     35  
Region of Enrollment  
[units: participants]
 
United States     45  



  Outcome Measures
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1.  Primary:   Oxygen Consumption   [ Time Frame: in-lab visit when propelling on a computer controlled wheelchair dynamometer ]

2.  Primary:   Oxygen Consumption   [ Time Frame: in-lab visit when propelling on a computer controlled wheelchair dynamometer ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rory Cooper, PhD
Organization: Human Engineering Research Laboratories
phone: 412-822-3700
e-mail: rcooper@pitt.edu


No publications provided


Responsible Party: Rory Cooper, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT00281463     History of Changes
Other Study ID Numbers: 01103, 010842, H133N000019
Study First Received: January 23, 2006
Results First Received: November 6, 2014
Last Updated: November 6, 2014
Health Authority: United States: Federal Government