The Effect of Foot Orthoses on the Braking Response Time

Hallux Valgus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354066
• Other study ID #: 602006052013
• Secondary ID: INS-621000-0500
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

Device:
• Hallux valgus Shoe
Brake response measurement after surgery with this foot orthosis
• Forefoot relief shoe
Brake response measurement after surgery with this foot orthosis
• Retail Shoe
Brake response time measurement before surgery (control run)

Locations

Country	Name	City	State
Austria	Department of Orthopedic; Medical University of Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View 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. Erratum in: Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1932. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brake response time after hallux valgus surgery with the investigated foot orthoses		July 2015 (The overall time frame is about nine weeks)