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

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Completed
CT.gov ID
NCT02105038
Collaborator
(none)
24
1
2
22
1.1

Study Details

Study Description

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
  • Other: Spinner knob
  • Other: No Knob
N/A

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

Study Type:
Interventional
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 :
Apr 1, 2014
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

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

Primary Outcome Measures

  1. Steering reaction time [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 [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

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Greenville Health System Greenville South Carolina United States 29605

Sponsors and Collaborators

  • Prisma Health-Upstate

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prisma Health-Upstate
ClinicalTrials.gov Identifier:
NCT02105038
Other Study ID Numbers:
  • Pro00026777
First Posted:
Apr 7, 2014
Last Update Posted:
Feb 11, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Prisma Health-Upstate
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2016