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

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ClinicalTrials.gov Identifier: NCT02105038
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Prisma Health-Upstate

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Other: Spinner knob Other: No Knob Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture
Study Start Date : April 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105038


Locations
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United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Prisma Health-Upstate
Investigators
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Principal Investigator: Kyle J Jeray, MD Prisma Health-Upstate
More Information
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Responsible Party: Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT02105038     History of Changes
Other Study ID Numbers: Pro00026777
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by Prisma Health-Upstate:
distal radius fracture
steering
steering wheel spinner knob
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries