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The Effect of Foot Orthoses on the Braking Response Time

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02354066
Enrollment
42
Registered
2015-02-03
Start date
2013-06-30
Completion date
2015-09-30
Last updated
2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

Keywords

Hallux valgus surgery, forefoot surgery, brake response time, foot orthoses

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.

Interventions

DEVICEHallux valgus Shoe

Brake response measurement after surgery with this foot orthosis

DEVICEForefoot relief shoe

Brake response measurement after surgery with this foot orthosis

DEVICERetail Shoe

Brake response time measurement before surgery (control run)

Sponsors

Medical University Innsbruck
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Brake response time after hallux valgus surgery with the investigated foot orthosesJuly 2015 (The overall time frame is about nine weeks)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026