Clinical trial NCT02354066: The Effect of Foot Orthoses on the Braking Response Time
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: Hallux valgus surgery
forefoot surgery
brake response time
foot orthoses
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brake response time after hallux valgus surgery with the investigated foot orthoses
timeFrame: July 2015 (The overall time frame is about nine weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Orthopedic; Medical University of Innsbruck
state: Tyrol
Study officials:
affiliation: University Hospital of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria, Europe
name: Rainer Biedermann, Priv.Doz.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dammerer D, Giesinger JM, Biedermann R, Haid C, Krismer M, Liebensteiner M. Effect of knee brace type on braking response time during automobile driving. Arthroscopy. 2015 Mar;31(3):404-9. doi: 10.1016/j.arthro.2014.09.003. Epub 2014 Nov 8.
citation: Liebensteiner MC, Rochau H, Renz P, Smekal V, Rosenberger R, Birkfellner F, Haid C, Krismer M. Brake response time returns to the pre-surgical level 6 weeks after unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1926-31. doi: 10.1007/s00167-014-3050-1. Epub 2014 May 15.
citation: Dammerer D, Braito M, Biedermann R, Ban M, Giesinger J, Haid C, Liebensteiner MC, Kaufmann G. Effect of surgical shoes on brake response time after first metatarsal osteotomy--a prospective cohort study. J Orthop Surg Res. 2016 Jan 20;11:14. doi: 10.1186/s13018-016-0350-9.