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

• Sponsor: VA Pittsburgh Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00281463
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Duration (Months): 74
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wheelchair Users	Device: Pushrim Activated Power Assist	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
• Study Start Date: Nov 1, 2001
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

1. Oxygen Consumption [in-lab visit when propelling on a computer controlled wheelchair dynamometer]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rory Cooper, Director; Pittsburgh VA Rehabilitation Research & Development Center, VA Pittsburgh Healthcare System
• ClinicalTrials.gov Identifier: NCT00281463
• Other Study ID Numbers: 01103, 010842; H133N000019
• First Posted: Jan 24, 2006
• Last Update Posted: Nov 18, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Rory Cooper, Director; Pittsburgh VA Rehabilitation Research & Development Center, VA Pittsburgh Healthcare System: wheelchair; spinal cord injury; rehabilitation
• Additional relevant MeSH terms: Quadriplegia

Study Results

Participant Flow

Arm/Group Title	Pushrim Activated Power Assist Wheelchair
Arm/Group Description	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).
Period Title: Overall Study
STARTED	45
COMPLETED	45
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Pushrim Activated Power Assist Wheelchair
Arm/Group Description	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).
Overall Participants	45
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	45 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	10 22.2%
Male	35 77.8%
Region of Enrollment (participants) [Number]
United States	45 100%

Outcome Measures

1. Primary Outcome

Title	Oxygen Consumption
Time Frame	in-lab visit when propelling on a computer controlled wheelchair dynamometer

Outcome Measure Data

Analysis Population Description

personal w/c (.9 m/s, 10 W)

Arm/Group Title	Pushrim Activated Power Assist Wheelchair
Arm/Group Description	Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Measure Participants	15
Mean (Standard Deviation) [VO2 (ml/min)]	625 (316)

2. Primary Outcome

Title	Oxygen Consumption
Time Frame	in-lab visit when propelling on a computer controlled wheelchair dynamometer

Outcome Measure Data

Analysis Population Description

PAPAW (.9 m/s, 10 W)

Arm/Group Title	Pushrim Activated Power Assist Wheelchair
Arm/Group Description	Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
Measure Participants	15
Mean (Standard Deviation) [VO2 (ml/min)]	415 (204)

Adverse Events

Arm/Group Title	Pushrim Activated Power Assist Wheelchair
Arm/Group Description	Participants were 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).
All Cause Mortality
	Pushrim Activated Power Assist Wheelchair
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pushrim Activated Power Assist Wheelchair
	Affected / at Risk (%)	# Events
Total	0/45 (0%)
Other (Not Including Serious) Adverse Events
	Pushrim Activated Power Assist Wheelchair
	Affected / at Risk (%)	# Events
Total	0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.