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Development of an Ergonomic Wheelchair Pushrim

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Natural-Fit

PalmRim

Handrim Control Group

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring Wheelchair, Handrims, Rehabilitation, Upper extremity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Human Engineering Research Laboratories

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

PalmRim Experimental

Natural-Fix Experiment

Handrim Control

Arm Description

Participants will have PalmRim installed on their wheelchair.

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

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

Outcomes

Primary Outcome Measures

Change in Functional Status Score

The Functional Status Scale, which measures hand and wrist symptoms.

Secondary Outcome Measures

Full Information

NCT ID

NCT00392860

First Posted

October 24, 2006

Last Updated

January 4, 2014

Sponsor

VA Pittsburgh Healthcare System

Collaborators

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT00392860

Brief Title

Development of an Ergonomic Wheelchair Pushrim

Official Title

Development of an Ergonomic Manual Wheelchair Pushrim- Phase II

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

VA Pittsburgh Healthcare System

Collaborators

University of Pittsburgh

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

Keywords

Wheelchair, Handrims, Rehabilitation, Upper extremity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PalmRim Experimental

Arm Type

Experimental

Arm Description

Participants will have PalmRim installed on their wheelchair.

Arm Title

Natural-Fix Experiment

Arm Type

Experimental

Arm Description

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

Arm Title

Handrim Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Natural-Fit

Intervention Description

Ergonomic handrim for wheelchairs

Intervention Type

Device

Intervention Name(s)

PalmRim

Intervention Description

Ergonomic handrim for wheelchair

Intervention Type

Device

Intervention Name(s)

Handrim Control Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Functional Status Score

Description

The Functional Status Scale, which measures hand and wrist symptoms.

Time Frame

Baseline, 4 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael L Boninger, MD

Organizational Affiliation

University of Pittsburgh and VA Pittsburgh Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Human Engineering Research Laboratories

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

12. IPD Sharing Statement

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Development of an Ergonomic Wheelchair Pushrim

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