Development of an Ergonomic Wheelchair Pushrim

January 4, 2014 updated by: Michael Boninger, VA Pittsburgh Healthcare System

Development of an Ergonomic Manual Wheelchair Pushrim- Phase II

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Human Engineering Research Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PalmRim Experimental
Participants will have PalmRim installed on their wheelchair.
Device: PalmRim
Ergonomic handrim for wheelchair
Experimental: Natural-Fix Experiment
Participants will have a Natural-Fit installed on their wheelchair.
Device: Natural-Fit
Ergonomic handrim for wheelchairs
Placebo Comparator: Handrim Control
Participants in this arm had a new standard handrim installed on their wheelchair as a control.
Device: Handrim Control Group
Participants were given a new standard handrim to test. This intervention group is the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Status Score
Time Frame: Baseline, 4 Months
The Functional Status Scale, which measures hand and wrist symptoms.
Baseline, 4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Pittsburgh Healthcare System

Collaborators

University of Pittsburgh

Investigators

  • Principal Investigator: Michael L Boninger, MD, University of Pittsburgh and VA Pittsburgh Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

October 24, 2006

First Submitted That Met QC Criteria

October 24, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

January 4, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02484, 0511136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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