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The Effect of Foot Orthoses on the Braking Response Time

Primary Purpose

Hallux Valgus

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Hallux valgus Shoe
Forefoot relief shoe
Retail Shoe
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hallux Valgus focused on measuring Hallux valgus surgery, forefoot surgery, brake response time, foot orthoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Orthopedic; Medical University of Innsbruck

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Hallux valgus Surgery

Hallux valgus and forefoot surgery

Control Run

Arm Description

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

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.)

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

Outcomes

Primary Outcome Measures

Brake response time after hallux valgus surgery with the investigated foot orthoses

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
March 27, 2020
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT02354066
Brief Title
The Effect of Foot Orthoses on the Braking Response Time
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Hallux valgus surgery (Chevron, Austin, SCARF, Akin etc.) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Hallux valgus surgery, forefoot surgery, brake response time, foot orthoses

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hallux valgus Surgery
Arm Type
Experimental
Arm Description
Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.)
Arm Title
Hallux valgus and forefoot surgery
Arm Type
Experimental
Arm 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.)
Arm Title
Control Run
Arm Type
Experimental
Arm Description
Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses
Intervention Type
Device
Intervention Name(s)
Hallux valgus Shoe
Other Intervention Name(s)
ofa® hallux valgus shoe
Intervention Description
Brake response measurement after surgery with this foot orthosis
Intervention Type
Device
Intervention Name(s)
Forefoot relief shoe
Other Intervention Name(s)
GloboPed® Forefoot relief orthosis
Intervention Description
Brake response measurement after surgery with this foot orthosis
Intervention Type
Device
Intervention Name(s)
Retail Shoe
Intervention Description
Brake response time measurement before surgery (control run)
Primary Outcome Measure Information:
Title
Brake response time after hallux valgus surgery with the investigated foot orthoses
Time Frame
July 2015 (The overall time frame is about nine weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Biedermann, Priv.Doz.Dr.
Organizational Affiliation
University Hospital of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria, Europe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedic; Medical University of Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
25442646
Citation
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.
Results Reference
background
PubMed Identifier
24832693
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.
Results Reference
background
PubMed Identifier
26792613
Citation
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.
Results Reference
derived

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The Effect of Foot Orthoses on the Braking Response Time

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