Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture

February 10, 2016 updated by: Prisma Health-Upstate
The aims of the study are to better understand how upper extremity injury and immobilization influences a patient's steering ability. Patients with acute distal radius fractures treated with surgery will be recruited for study in a driving simulator. The results will hopefully assist physicians to better counsel patients with upper extremity injuries on when it is safe to return to driving.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ability of an injured person to safely drive an automobile while immobilized in an upper extremity cast or splint is not well defined.

The aims of the study are to better understand how upper extremity injury and immobilization influences a patient's steering ability. The secondary aim is to further evaluate the effectiveness of a steering wheel spinner-knob to assist with one-handed driving. A steering wheel spinner knob may be a surrogate to assist with one handed driving while immobilized.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Acute distal radius fracture treated with surgery and initially immobilized in a cast or splint

    • Valid driver's license with 1 years of driving experience and actively driving during the last three months
    • English speaking
    • Ability to start testing within 10 days of surgery

Exclusion Criteria:

  • • <18 years of age

    • Current use of steering wheel spinner knob or hand controls while driving
    • Non-drivers
    • Multi-trauma
    • Open fractures
    • Surgical repair with external fixation
    • Concurrent distal radius/ulnar joint injury and repair
    • Any other joint besides the wrist immobilized following surgery
    • Contralateral upper extremity disability
    • Previous ipsilateral upper extremity functional deficit
    • Inability to participate for the full length of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knob
Steering in a driving simulator using a steering wheel spinner knob.
Other: Spinner knob
Active Comparator: No Knob
Steering in a driving simulator immediately following surgical treatment of hip fractures.
Other: No Knob

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steering reaction time
Time Frame: 6 months
Steering reaction time measured using a driving simulator will be compared across three time points (acutely, sub-acutely, and return to function) following surgical treatment of a distal radius fractures. This will be evaluated with and without the use of a steering wheel spinner knob.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steering accuracy
Time Frame: 6 months
Steering accuracy measured using a driving simulator will be compared across three time points (acutely, sub-acutely, and return to function) following surgical treatment of a distal radius fractures. This will be evaluated with and without the use of a steering wheel spinner knob.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Investigators

  • Principal Investigator: Kyle J Jeray, MD, Prisma Health-Upstate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00026777

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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