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

Not Applicable

Completed

Conditions: Wheelchair Users

Interventions: Device: Pushrim Activated Power Assist

Registration Number: NCT00281463

Lead Sponsor: VA Pittsburgh Healthcare System

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pushrim Activated Power Assist Wheelchair	Pushrim Activated Power Assist	Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.

Primary Outcome Measures