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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE April 7, 2014
Last Update Posted Date February 11, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02105038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture
Official Title  ICMJE Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Distal Radius Fracture
Intervention  ICMJE
  • Other: Spinner knob
  • Other: No Knob
Study Arms  ICMJE
  • Experimental: Knob
    Steering in a driving simulator using a steering wheel spinner knob.
    Intervention: Other: Spinner knob
  • Active Comparator: No Knob
    Steering in a driving simulator immediately following surgical treatment of hip fractures.
    Intervention: Other: No Knob
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2014)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02105038
Other Study ID Numbers  ICMJE Pro00026777
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prisma Health-Upstate
Study Sponsor  ICMJE Prisma Health-Upstate
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyle J Jeray, MD Prisma Health-Upstate
PRS Account Prisma Health-Upstate
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP