Development of an Ergonomic Wheelchair Pushrim

NCT ID: NCT00392860

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-09-30

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PalmRim Experimental

Participants will have PalmRim installed on their wheelchair.

Group Type: EXPERIMENTAL

PalmRim

Intervention Type: DEVICE

Ergonomic handrim for wheelchair

Natural-Fix Experiment

Participants will have a Natural-Fit installed on their wheelchair.

Group Type: EXPERIMENTAL

Natural-Fit

Intervention Type: DEVICE

Ergonomic handrim for wheelchairs

Handrim Control

Participants in this arm had a new standard handrim installed on their wheelchair as a control.

Group Type: PLACEBO_COMPARATOR

Handrim Control Group

Intervention Type: DEVICE

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

Interventions

Natural-Fit

Ergonomic handrim for wheelchairs

Intervention Type: DEVICE

PalmRim

Ergonomic handrim for wheelchair

Intervention Type: DEVICE

Handrim Control Group

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

PalmRim

• Pressure sores

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

VA Pittsburgh Healthcare System

FED

Sponsor Role: lead

Responsible Party

Michael Boninger

Chair, Department of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael L Boninger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh and VA Pittsburgh Healthcare System

Locations

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

02484, 0511136

Identifier Type: -

Identifier Source: org_study_id