The Effect of Foot Orthoses on the Braking Response Time

Medical University Innsbruck

Status: Completed

Conditions: Hallux Valgus

Treatments: Device: Forefoot relief shoe; Device: Hallux valgus Shoe; Device: Retail Shoe

Study type: Interventional

Funder types: Other

Identifiers

NCT02354066

602006052013

INS-621000-0500 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Hallux valgus Surgery

Experimental group

Description:

Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.)

Treatment:

Device: Hallux valgus Shoe

Device: Forefoot relief shoe

Hallux valgus and forefoot surgery

Experimental group

Description:

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.)

Treatment:

Device: Hallux valgus Shoe

Device: Forefoot relief shoe

Control Run

Experimental group

Description:

Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses

Treatment:

Device: Hallux valgus Shoe

Device: Forefoot relief shoe

Device: Retail Shoe