Development of an Ergonomic Wheelchair Pushrim

Spinal Cord Injury Clinical Trial

Official title:

Development of an Ergonomic Manual Wheelchair Pushrim- Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392860
• Other study ID #: 02484, 0511136
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2006
• Last updated: January 4, 2014
• Start date: August 2008
• Est. completion date: September 2011

Study information

• Verified date: January 2014
• Source: VA Pittsburgh Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Natural-Fit
Ergonomic handrim for wheelchairs
• PalmRim
Ergonomic handrim for wheelchair
• Handrim Control Group
Participants were given a new standard handrim to test. This intervention group is the control group.

Locations

Country	Name	City	State
United States	Human Engineering Research Laboratories	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Pittsburgh Healthcare System	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Functional Status Score	The Functional Status Scale, which measures hand and wrist symptoms.	Baseline, 4 Months	No

External Links

•   Human Engineering Research Laboratories