Development of an Ergonomic Wheelchair Pushrim

Phase 2

Completed

• Conditions: Spinal Cord Injury
• Interventions: Device: PalmRim; Device: Natural-Fit; Device: Handrim Control Group

• Registration Number: NCT00392860
• Lead Sponsor: VA Pittsburgh Healthcare System

Brief Summary

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.

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 Timeline

• Study First Submitted: 2006-10-24
• Study First Submitted QC: 2006-10-24
• Study First Posted: 2006-10-26
• Study Start: 2008-08
• Primary Completion: 2011-03
• Study Completion: 2011-09
• Results First Submitted: 2013-06-18
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-04
• Last Update Submitted: 2014-01-04
• Results First Posted: 2014-02-21
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PalmRim Experimental	PalmRim	Participants will have PalmRim installed on their wheelchair.
Natural-Fix Experiment	Natural-Fit	Participants will have a Natural-Fit installed on their wheelchair.
Handrim Control	Handrim Control Group	Participants in this arm had a new standard handrim installed on their wheelchair as a control.

Primary Outcome Measures

Name	Time	Method
Change in Functional Status Score	Baseline, 4 Months	The Functional Status Scale, which measures hand and wrist symptoms.

Trial Locations

Locations (1)

Human Engineering Research Laboratories; 🇺🇸 Pittsburgh, Pennsylvania, United States