Development of an Ergonomic Wheelchair Pushrim

NCT00392860 | Completed Phase 2 Results

• 1 other identifier: 02484, 0511136
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Wheelchair; Handrims; Rehabilitation; Upper extremity

Outcome Measures

Primary Outcomes (1)

• Change in Functional Status Score

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

  Baseline, 4 Months

Study Arms (3)

PalmRim Experimental

EXPERIMENTAL

Participants will have PalmRim installed on their wheelchair.

Device: PalmRim

Natural-Fix Experiment

EXPERIMENTAL

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

Device: Natural-Fit

Handrim Control

PLACEBO COMPARATOR

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

Device: Handrim Control Group

Interventions

Natural-Fit DEVICE

Ergonomic handrim for wheelchairs

Natural-Fix Experiment

PalmRim DEVICE

Ergonomic handrim for wheelchair

PalmRim Experimental

Handrim Control Group DEVICE

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

Handrim Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pressure Sores
• PalmRim
• 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
• Pressure sores

Sponsors & Collaborators

• VA Pittsburgh Healthcare System: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Michael L Boninger
• Organization: Human Engineering Research Laboratories

boninger@upmc.edu

412-822-3700

Study Officials

• Michael L Boninger, MD

  University of Pittsburgh and VA Pittsburgh Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: October 24, 2006
• First Posted: October 26, 2006
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 21, 2014
• Results First Posted: February 21, 2014

Record last verified: 2014-01

Locations

US (1)