Femoral AnteversionNCT03812822
Describing the Effects of Insoles in Children With Increased Femoral Anteversion and Pes Planovalgus
A study testing Insole in people with Femoral Anteversion and Pes Planovalgus, run by Istanbul Kültür University at 2 sites in Turkey (Türkiye).
Trial summary
Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment, walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Anteversion, Pes Planovalgus, Flat Foot
- What is being tested?
- Insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 24 Dec 2019
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Insole Group Between the ages 7-15, Trochanteric Prominens Angle Test > 20⁰, Hip internal rotation angle > 60⁰, Without insole Foot Posture Index score > 5, With insole Foot Posture Index score > 4, Using their insoles' at least one month.
- Control Group Between the ages 7-15, Trochanteric Prominens Angle Test < 20⁰, Foot Posture Index score < 5, Without any neurologic or orthopedic disease
Who cannot join
- Neurological and / or musculoskeletal problems, Orthopedic problems to prevent walking.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Kültür Üniversitesi
Istanbul
İstanbul University, Faculty of Medicine
Istanbul
About this study
Official title: The Effects of Using Insoles on Walking in Children With Increased Femoral Anteversion and Pes Planovalgus
Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment, walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. It is shown that children with IFA and PPV have back and leg pain, fatigue, muscle cramps and they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle injuries.
Insoles, which reduce pronation of foot (flat foot), provide apparently a static correction by supporting proper alignment in children with IFA and PPV. However, the dynamic effects of insoles to lower extremity biomechanics while walking is not known.
The aims of this study are to determine the effects of the insoles on walking biomechanics in children with IFA and PPV by comparing with their healthy peers.
- Conditions
- Femoral Anteversion, Pes Planovalgus, Flat Foot
- Being tested
- Insole
- Keywords
- Femoral anteversion, flat foot, insole, gait
- Medical subject headings
- Clubfoot, Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsoleDevice
Custom-made insoles which support the foot at subtalar neutral position
| Study group | Role | What they receive |
|---|---|---|
| Insole Group | Experimental | Gait and foot posture analysis with and without the insole. Receives: Device: Insole |
| Control Group | No intervention | Gait and foot posture analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Analysis
Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)
Measured: Day 1
Static Foot Posture Assesment
Foot Posture Index - 6 6 items ( 1.talar head palpation, 2.supra and infra lateral malleolar curvature,3.calcaneal frontal plane position, 4.prominence in the region of the talonavicular joint, 5.congruence of the medial longitudinal arch, and 6.abduction/adduction of the forefoot on the rearfoot)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Feb 2019
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral AnteversionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Evrendilek, Istanbul Kültür University
- Investigators
- Halenur Evrendilek, GRAD ASST, Study chair, İstanbul Kültür UniversityEkin Akalan, PROF, Study director, İstanbul Kültür UniversityMiray Budak, ASST PROF, Study director, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812822
- Sponsor's protocol ID
- 2018/376
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Insoles on Walking in Children With Increased Femoral Anteversion and Pes Planovalgus
- ClinicalTrials.gov ID
- NCT03812822
- Acronym / sponsor ID
- 2018/376
- Conditions
- Femoral Anteversion, Pes Planovalgus, Flat Foot
- Keywords
- Femoral anteversion, flat foot, insole, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- 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.
Increased Femoral Anteversion is a transverse plan problem that affects lower body alignment, walking and standing characteristics and also pes planovalgus mostly accompanies with IFA. It is shown that children with IFA and PPV have back and leg pain, fatigue, muscle cramps and they are under the risk for chronic disorders such as osteoarthritis, scoliosis and muscle injuries.
Insoles, which reduce pronation of foot (flat foot), provide apparently a static correction by supporting proper alignment in children with IFA and PPV. However, the dynamic effects of insoles to lower extremity biomechanics while walking is not known.
The aims of this study are to determine the effects of the insoles on walking biomechanics in children with IFA and PPV by comparing with their healthy peers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insole Group | Experimental | Device: InsoleGait and foot posture analysis with and without the insole. |
| Control Group | No intervention | –Gait and foot posture analysis. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Insole Group Between the ages 7-15, Trochanteric Prominens Angle Test > 20⁰, Hip internal rotation angle > 60⁰, Without insole Foot Posture Index score > 5, With insole Foot Posture Index score > 4, Using their insoles' at least one month.
- Control Group Between the ages 7-15, Trochanteric Prominens Angle Test < 20⁰, Foot Posture Index score < 5, Without any neurologic or orthopedic disease
Key exclusion criteria (1 listed)
- Neurological and / or musculoskeletal problems, Orthopedic problems to prevent walking.
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 |
|---|---|---|
| InsoleCustom-made insoles which support the foot at subtalar neutral position | Device | Insole Group |
Primary outcome
Gait Analysis
Time frame: Day 1
Three-dimensional gait analysis (Temporo-spatial parameters and pelvis, hip, knee and ankle kinematic in three plans)
Static Foot Posture Assesment
Time frame: Day 1
Foot Posture Index - 6 6 items ( 1.talar head palpation, 2.supra and infra lateral malleolar curvature,3.calcaneal frontal plane position, 4.prominence in the region of the talonavicular joint, 5.congruence of the medial longitudinal arch, and 6.abduction/adduction of the forefoot on the rearfoot)
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 13 Mar 2020.
- Individual participant dataSharing planned: Undecided
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.
Halenur Evrendilek, GRAD ASST study chair
İstanbul Kültür University
Ekin Akalan, PROF study director
İstanbul Kültür University
Miray Budak, ASST PROF study director
İstanbul Medipol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insole in people with Femoral Anteversion and Pes Planovalgus, run by Istanbul Kültür University at 2 sites in Turkey (Türkiye).
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 2 inclusion and 1 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 13 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 2 sites in Turkey (Türkiye). 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?
Gait Analysis (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2020.