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

NCT ID: NCT02105038

Last Updated: 2016-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Knob

Steering in a driving simulator using a steering wheel spinner knob.

Group Type EXPERIMENTAL

Spinner knob

Intervention Type OTHER

No Knob

Steering in a driving simulator immediately following surgical treatment of hip fractures.

Group Type ACTIVE_COMPARATOR

No Knob

Intervention Type OTHER

Interventions

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Spinner knob

Intervention Type OTHER

No Knob

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle J Jeray, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Upstate

Locations

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Greenville Health System

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00026777

Identifier Type: -

Identifier Source: org_study_id

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