Development of an Ergonomic Wheelchair Pushrim

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development of an Ergonomic Manual Wheelchair Pushrim- Phase II

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Natural-Fit
* Device: PalmRim
* Device: Handrim Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wheelchair, Handrims, Rehabilitation, Upper extremity