Hallux ValgusNCT02354066
The Effect of Foot Orthoses on the Braking Response Time
A study testing Hallux valgus Shoe, Forefoot relief shoe and Retail Shoe in people with Hallux Valgus, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Hallux valgus Shoe, Forefoot relief shoe and Retail Shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Department of Orthopedic; Medical University of Innsbruck
Innsbruck, Tyrol, 6020
About this study
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
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).
Read the 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.
- Conditions
- Hallux Valgus
- Being tested
- Hallux valgus Shoe, Forefoot relief shoe, Retail Shoe
- Keywords
- Hallux valgus surgery, forefoot surgery, brake response time, foot orthoses
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallux valgus ShoeDevice
Also called ofa® hallux valgus shoe
Brake response measurement after surgery with this foot orthosis
Forefoot relief shoeDevice
Also called GloboPed® Forefoot relief orthosis
Brake response measurement after surgery with this foot orthosis
Retail ShoeDevice
Brake response time measurement before surgery (control run)
| Study group | Role | What they receive |
|---|---|---|
| Hallux valgus Surgery | Experimental | Measurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.) Receives: Device: Hallux valgus Shoe; Device: Forefoot relief shoe |
| Hallux valgus and forefoot surgery | Experimental | 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.) Receives: Device: Hallux valgus Shoe; Device: Forefoot relief shoe |
| Control Run | Experimental | Measurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses Receives: Device: Hallux valgus Shoe; Device: Forefoot relief shoe; Device: Retail Shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brake response time after hallux valgus surgery with the investigated foot orthoses
Measured: July 2015 (The overall time frame is about nine weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJun 2013
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dammerer Dietmar, MD, Medical University Innsbruck
- Investigators
- Rainer Biedermann, Priv.Doz.Dr., Principal investigator, University Hospital of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria, Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354066
- Sponsor's protocol ID
- 602006052013
- Other IDs
- INS-621000-0500
- Status last verified
- Sep 2015
- First submitted
- 13 Jan 2015
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25442646Liebensteiner 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.
PubMed 24832693Dammerer 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.
PubMed 26792613
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02354066
- Acronym / sponsor ID
- 602006052013
- Conditions
- Hallux Valgus
- Keywords
- Hallux valgus surgery, forefoot surgery, brake response time, foot orthoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hallux valgus Surgery | Experimental | Device: Hallux valgus Shoe, Device: Forefoot relief shoeMeasurement of the Brake Response Time by Pat. undergoing hallux valgus surgery (first metatarsal osteotomy, Chevron, SCARF, Austin, etc.) |
| Hallux valgus and forefoot surgery | Experimental | Device: Hallux valgus Shoe, Device: Forefoot relief shoeMeasurement 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 | Experimental | Device: Hallux valgus Shoe, Device: Forefoot relief shoe, Device: Retail ShoeMeasurement of the Brake Response Time by Healthy Participants; control run; brake response time measurement with normal shoe and both foot orthoses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hallux valgus ShoeAlso: ofa® hallux valgus shoeBrake response measurement after surgery with this foot orthosis | Device | Control Run, Hallux valgus Surgery, Hallux valgus and forefoot surgery |
| Forefoot relief shoeAlso: GloboPed® Forefoot relief orthosisBrake response measurement after surgery with this foot orthosis | Device | Control Run, Hallux valgus Surgery, Hallux valgus and forefoot surgery |
| Retail ShoeBrake response time measurement before surgery (control run) | Device | Control Run |
Primary outcome
Brake response time after hallux valgus surgery with the investigated foot orthoses
Time frame: July 2015 (The overall time frame is about nine weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 25442646Dammerer 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.
- Background: PubMed 24832693Liebensteiner 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.
- Derived from this study: PubMed 26792613Dammerer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Biedermann, Priv.Doz.Dr. principal investigator
University Hospital of Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria, Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hallux valgus Shoe, Forefoot relief shoe and Retail Shoe in people with Hallux Valgus, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brake response time after hallux valgus surgery with the investigated foot orthoses (time frame: July 2015 (The overall time frame is about nine weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354066, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.