The Effect of Foot Orthoses on the Braking Response Time
NCT ID: NCT02354066
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2013-06-30
2015-09-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Hallux valgus Surgery
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.)
Hallux valgus Shoe
Brake response measurement after surgery with this foot orthosis
Forefoot relief shoe
Brake response measurement after surgery with this foot orthosis
Hallux valgus and forefoot surgery
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.)
Hallux valgus Shoe
Brake response measurement after surgery with this foot orthosis
Forefoot relief shoe
Brake response measurement after surgery with this foot orthosis
Control Run
Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* used the right foot exclusively for accelerating and braking,
* free of any medical condition that could impair the ability to drive
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Dammerer Dietmar, MD
Dr. med. univ. Dietmar Dammerer
Principal Investigators
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Rainer Biedermann, Priv.Doz.Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria, Europe
Locations
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Department of Orthopedic; Medical University of Innsbruck
Innsbruck, Tyrol, Austria
Countries
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References
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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.
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.
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.
Other Identifiers
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INS-621000-0500
Identifier Type: REGISTRY
Identifier Source: secondary_id
602006052013
Identifier Type: -
Identifier Source: org_study_id
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