Predictability of the Ability to Perform an Emergency Stop

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-06-30

Brief Summary

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Several studies exist on patient performance in drive simulators especially around and after surgery. Recommendations concerning the ability to drive preoperatively are based on these studies, which generated their data using drive simulators. However, in all the datasets driving performance remains highly individual. Since a drive simulator is not readily available in normal general practitioner surgeries it would be helpful to have convenient clinical tests to evaluate a patients individual ability to perform an emergency stop. This study aims at evaluating different possibilities how such performance might be predicted. Patients with knee osteoarthritis and patients who have received total knee arthroplasty are tested clinically and their results are compared with the gold standard experiment - a drive simulator.

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Detailed Description

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Conditions

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Osteoarthritis Total Knee Arthroplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Braking and functionality with right knee osteoarthritis

Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right knee osteoarthritis

Group Type EXPERIMENTAL

Braking and functionality

Intervention Type OTHER

Braking and functionality with right knee arthroplasty

Cohort testing of driving performance in a drive simulator and correlation with clinical functionality in patients with right total knee arthroplasty

Group Type EXPERIMENTAL

Braking and functionality

Intervention Type OTHER

Interventions

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Braking and functionality

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-85 y
* valid driving license
* male and female
* right or left knee Osteoarthritis, Total knee arthroplasty right or left knee
* capability to walk with or without a walking stick

Exclusion Criteria

* myocardial infarction/Apoplexia \< 6 months
* Total knee arthroplasty \<5 weeks
* New York Heart Association 3/4
* lacking drivers' license
* peripheric sensomotor deficit \<3/5 British Medical Research Council
* new fracture of the lower extremity or spine
* systemic or metastasised Cancer
* drug intake with centrally acting substances known to affect reaction time (Opioids, e.g. Tramadol, oxycodone, morphine, Tilidin)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes