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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105038
• Other study ID #: Pro00026777
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: February 10, 2016
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Greenville Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Spinner knob

• No Knob

Locations

Country	Name	City	State
United States	Greenville Health System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Greenville Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Steering accuracy	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	No