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Completed

NCT Number: NCT02354066

The Effect of Foot Orthoses on the Braking Response Time

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopedic; Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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:

  • Hallux valgus surgery (Chevron, Austin, SCARF, Akin etc.)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hallux valgus Shoe

Device

Brake response measurement after surgery with this foot orthosis

Other names: ofa® hallux valgus shoe

Forefoot relief shoe

Device

Brake response measurement after surgery with this foot orthosis

Other names: GloboPed® Forefoot relief orthosis

Retail Shoe

Device

Brake response time measurement before surgery (control run)

Primary outcomes

  1. Brake response time after hallux valgus surgery with the investigated foot orthoses

    Time frame: July 2015 (The overall time frame is about nine weeks)

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2015
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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