The Effect of Foot Orthoses on the Braking Response Time

March 27, 2020 updated by: Dammerer Dietmar, MD, Medical University Innsbruck

The Effect of Different Foot Orthoses (Hallux Valgus Shoe; Forefoot Relief Shoe) on the Brake Response Time After Hallux Valgus and/or Additional Forefoot Surgery

Patients often seek advice from their treating doctor if they are able to drive with a foot orthosis after a first metatarsal osteotomy for symptomatic hallux valgus and/or after an additional forefoot surgery. This challenging question is of obvious importance for the patient and other road users. Previous studies already issued driving ability after different orthopedic procedures and with knee and ankle devices on the brake reaction time but missed to address the same for foot orthoses after hallux valgus or forefoot surgery.

This missing evidence made us evaluate the influence of wearing a foot orthosis after a first metatarsal osteotomy or forefoot surgery on driving ability (brake response time; BRT).

The overall time frame is about nine weeks; each appointment for BRT measurement takes about fifteen to twenty minutes. The first BRT measurement is one day before the foot surgery without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2), two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and eight weeks postoperative without a foot orthoses (6).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to asses driving ability (brake response time) and the influence of two types of different foot orthoses after foot surgery.

Therefore we have two groups:

  1. Hallux valgus surgery (Chevron, Austin, SCARF, Akin etc.)
  2. Hallux valgus and additional forefoot surgery (Chevron, Austin, SCARF, Akin etc. and WEIL - Osteotomy, Peg-in-Hole, etc.)

BRT (brake response time) is assessed with commonly used right-sided hallux valgus shoes (HVS) and forefoot relief shoes (FRS). We measure the BRT at six different time points: one day before surgery without a foot orthosis (normal shoe)and with the orthoses (control run) (1) at two days (2), two weeks (3), four weeks (4) and six weeks (5) after the operation with a HVS and a FRS and eight weeks postoperative without a foot orthoses (6). The overall time frame is about nine weeks; each appointment for BRT measurement takes about fifteen to twenty minutes.

The BRT was assessed using a custom-made driving simulator as used in previously published studies. Participants were instructed to apply the brake pedal exclusively with the right foot as quickly as possible on a visual stimulus. The time interval until the subject operated the brake was measured 20 times, averaged and then taken as BRT value.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Department of Orthopedic; Medical University of Innsbruck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • participants must have a valid driver´s license,
  • used the right foot exclusively for accelerating and braking,
  • free of any medical condition that could impair the ability to drive

Exclusion Criteria:

  • taking medications that could affect reaction time (e.g. benzodiazepines and over-the-counter allergy and cold medications)
  • had a history of alcohol or drug abuse,
  • a central nervous system disorder such as epilepsy,
  • a metabolic disorder,
  • a psychiatric disorder,
  • musculoskeletal disease,
  • any visual acuity disorder (macular degeneration etc.; glasses allowed)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hallux valgus Surgery
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.)
Device: Hallux valgus Shoe
Brake response measurement after surgery with this foot orthosis
Other Names:
  • ofa® hallux valgus shoe
Device: Forefoot relief shoe
Brake response measurement after surgery with this foot orthosis
Other Names:
  • GloboPed® Forefoot relief orthosis
EXPERIMENTAL: Hallux valgus and forefoot surgery
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy; Chevron, Austin, SCARF, etc.) and additional forefoot surgery (PIP arthrodesis, second/third/etc. metatarsal osteotomy, etc.; Peg-in-Hole, WEIL-Osteotomy, etc.)
Device: Hallux valgus Shoe
Brake response measurement after surgery with this foot orthosis
Other Names:
  • ofa® hallux valgus shoe
Device: Forefoot relief shoe
Brake response measurement after surgery with this foot orthosis
Other Names:
  • GloboPed® Forefoot relief orthosis
EXPERIMENTAL: Control Run
Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses
Device: Hallux valgus Shoe
Brake response measurement after surgery with this foot orthosis
Other Names:
  • ofa® hallux valgus shoe
Device: Forefoot relief shoe
Brake response measurement after surgery with this foot orthosis
Other Names:
  • GloboPed® Forefoot relief orthosis
Device: Retail Shoe
Brake response time measurement before surgery (control run)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brake response time after hallux valgus surgery with the investigated foot orthoses
Time Frame: July 2015 (The overall time frame is about nine weeks)
July 2015 (The overall time frame is about nine weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Rainer Biedermann, Priv.Doz.Dr., University Hospital of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria, Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (ESTIMATE)

February 3, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 602006052013
  • INS-621000-0500 (REGISTRY: Austria: Agency for Health and Food Safety)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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