Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 11, 2016
February 1, 2016
1.8 years
March 24, 2014
February 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Steering reaction time
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 Outcomes (1)
Steering accuracy
6 months
Study Arms (2)
Knob
EXPERIMENTALSteering in a driving simulator using a steering wheel spinner knob.
No Knob
ACTIVE COMPARATORSteering in a driving simulator immediately following surgical treatment of hip fractures.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \<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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Greenville Health System
Greenville, South Carolina, 29605, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyle J Jeray, MD
Prisma Health-Upstate
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
April 7, 2014
Study Start
April 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 11, 2016
Record last verified: 2016-02