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
2 other identifiers
interventional
42
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
February 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 31, 2020
September 1, 2015
2.2 years
January 13, 2015
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brake response time after hallux valgus surgery with the investigated foot orthoses
July 2015 (The overall time frame is about nine weeks)
Study Arms (3)
Hallux valgus Surgery
EXPERIMENTALMeasurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.)
Hallux valgus and forefoot surgery
EXPERIMENTALMeasurement 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.)
Control Run
EXPERIMENTALMeasurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses
Interventions
Brake response measurement after surgery with this foot orthosis
Brake response measurement after surgery with this foot orthosis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopedic; Medical University of Innsbruck
Innsbruck, Tyrol, 6020, Austria
Related Publications (3)
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.
PMID: 25442646BACKGROUNDLiebensteiner 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.
PMID: 24832693BACKGROUNDDammerer 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.
PMID: 26792613DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rainer Biedermann, Priv.Doz.Dr.
University Hospital of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria, Europe
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med. univ. Dietmar Dammerer
Study Record Dates
First Submitted
January 13, 2015
First Posted
February 3, 2015
Study Start
June 1, 2013
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
March 31, 2020
Record last verified: 2015-09