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OpenTrials
Completed

NCT Number: NCT00392860

Development of an Ergonomic Wheelchair Pushrim

The purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

About this study

This research will have three parts.

The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.

For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.

In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Natural-Fit

Inclusion criteria

  • Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
  • Use a standard handrim
  • Between the ages of 18 and 55
  • Has normal hand function

Exclusion criteria

  • Pressure Sores

PalmRim

Inclusion criteria

  • Use of a manual wheelchair as a primary means of mobility (over 40 hours per week)
  • Use a vinyl-coated handrim
  • Between ages 18 and 55
  • Has impaired hand function

Exclusion criteria

  • Pressure sores

Treatment and study plan

Natural-Fit

Device

Ergonomic handrim for wheelchairs

PalmRim

Device

Ergonomic handrim for wheelchair

Handrim Control Group

Device

Participants were given a new standard handrim to test. This intervention group is the control group.

Primary outcomes

  1. Change in Functional Status Score

    Time frame: Baseline, 4 Months

    The Functional Status Scale, which measures hand and wrist symptoms.

Sponsors and collaborators

Lead sponsor

VA Pittsburgh Healthcare System

Fed

Collaborators

  • University of Pittsburgh

Registry information

Official study title

Development of an Ergonomic Manual Wheelchair Pushrim- Phase II

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 26, 2006
Registry last updated
Feb 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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