Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
Primary Purpose
Wheelchair Users
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pushrim Activated Power Assist
Sponsored by
About this trial
This is an interventional basic science trial for Wheelchair Users focused on measuring wheelchair, spinal cord injury, rehabilitation
Eligibility 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.
Sites / Locations
- Human Engineering Research Laboratories
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pushrim Activated Power Assist Wheelchair
Arm Description
Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Outcomes
Primary Outcome Measures
Oxygen Consumption
Secondary Outcome Measures
Full Information
NCT ID
NCT00281463
First Posted
January 23, 2006
Last Updated
November 6, 2014
Sponsor
VA Pittsburgh Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT00281463
Brief Title
Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
Official Title
Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Pittsburgh Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheelchair Users
Keywords
wheelchair, spinal cord injury, rehabilitation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pushrim Activated Power Assist Wheelchair
Arm Type
Experimental
Arm Description
Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Intervention Type
Device
Intervention Name(s)
Pushrim Activated Power Assist
Intervention Description
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).
Primary Outcome Measure Information:
Title
Oxygen Consumption
Time Frame
in-lab visit when propelling on a computer controlled wheelchair dynamometer
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rory A Cooper, PhD
Organizational Affiliation
Human Engineering Research Laboratories
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Engineering Research Laboratories
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
12. IPD Sharing Statement
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Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
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