Pes PlanusNCT03151538
Effects on Pes Planus Exercise Training Mixed With Play on Pre-school Children
A study testing Exercise Training Mixed With Play in people with Pes Planus and Flat Foot, run by Burcu Talu at 1 site in Turkey (Türkiye).
Trial summary
The study was planned to assess effects on pes planus and femoral anteversion angle of exercise training mixed with play on pre-school children. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pes Planus, Flat Foot, Femoral Anteversion
- What is being tested?
- Exercise Training Mixed With Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2017to 14 Jun 2017
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in an age range of 4-7 years,
- Having bilateral or unilateral deformity with pes planus
- CSI range > % 62.7 measured by the referring physical therapist.
- Having no any foot surgeon,
- Without any neurological diseases,
- Who want to be involved voluntary work,
- Pre-school students who have been informed by their families(their families approved illuminated affirmation ).
Who cannot join
- Pre-school students who can not adapt to training,
- Students who do not want to be involved in voluntary work.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Preschool of Battalgazi and Yesilyurt district
Malatya, 44210
About this study
Official title: Assessment Effects on Pes Planus and Femoral Anteversion Angle of Exercise Training Mixed With Play on Pre-school Children
The study was planned to assess effects on pes planus and femoral anteversion angle of exercise training mixed with play on pre-school children.
Read the detailed description
Pes planus ( Pes planovalgus) is similar with flatfoot occurs collapse of medial longitudinal arch which is lower than normal range or occurs extra pressure on arch. It is separated two group such congenital (flexible and rigid) and acquired. The etiology of pes planus is that hallux rigidus, plantar calcaneonavicular ligament rupture, collapse of medial longitudinal arch, pathology of ligament and tendon, shortness Achilles tendon and juvenile hallux valgus. The most common causes of pes planus are outgroup of leg muscles (peroneal) spasticity, plantar fasciitis and tibial tendon insufficiency. Symptoms of pes planus are indicated heel pain, gait abnormalities, decreased dorsiflexion range of ankle, plantar ulceration, limited mobility of 1.metatarsophalangeal joint and spasm of peroneal muscle. There is a high prevalence rates among males and occur positive correlation between with pes planus and BMI. Evaluation methods of pes planus are X-ray, heel height, gait analysis and Achilles strain. The most commonly used method are line that medial malleolus, 1st metatarsal head and the navicula is on the same line, and the footprint technique from ink rubber plates. Treatment of pes planus is maintained medial displacement calcaneal osteotomy operation with the transfer of the flexor digitorum longus. Non- invasive treatment methods are given such as peroneal muscles and Achilles stretching exercises. 25 degree angle inverted foot orthoses are commonly used because of increasing stance phasic in treatment. Peroneal neural mobilization, play training and stretching exercises are often used treatment method of pes planus. Main purpose of this study is that assess effects of mixed training program with playing on pes planus and increased femoral anteversion angle in pre-school students.
- Conditions
- Pes Planus, Flat Foot, Femoral Anteversion
- Being tested
- Exercise Training Mixed With Play, Controlled
- Keywords
- Pedography, Exercise, Play Training, Pes Planus, Femoral Anteversion
- Medical subject headings
- Flatfoot, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training Mixed With PlayBehavioural
To assess effects of training program which includes mixed exercises with playing.Study included 90 pre-school children who suffer from pes planus and increased femoral anteversion angle. Demographic data, navicular height, weight-bearing and non-weight bearing of subtalar joint motion, metatarsal width(weight and non-weight), range of hallux valgus,height of foot, tension of Achilles tendon, habits of W standing(hour/day), angle of Quadriceps(Q degree), angle of hip rotation were recorded . Craig Test, foot posture index, Chippaux-Smirak Index(CSI),Beighton hypermobility score, valgus index, thigh foot angle examination were used. CSI measurements were positive correlation with severity of pes planus.
ControlledOther
First and last measurements will be done. There will be no intervention. Study will include 30 healthy pre-school children. Demographic data, navicular height, weight-bearing and non-weight bearing of subtalar joint motion, metatarsal width(weight and non-weight), range of hallux valgus,height of foot, tension of Achilles tendon, habits of W standing(hour/day), angle of Quadriceps(Q degree), angle of hip rotation were recorded . Craig Test, foot posture index, Chippaux-Smirak index(CSI),Beighton hypermobility score, valgus index, thigh foot angle examination were used.
| Study group | Role | What they receive |
|---|---|---|
| Pes Planus Group | Experimental | This group of patients received children with pes planus. It will be applied exercise training mixed with play Receives: Behavioral: Exercise Training Mixed With Play |
| Controlled Group | Other | This group of patients received healthy children. Receives: Other: Controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot print with pedography (%). Change from pes planus at 6 week.
It used to define pes planus.
Measured: 6 weeks
Secondary outcomes (6)
Change from Angle of Quadriceps at 6 week.
The test used for angle of hip anteversion. (Degree)
Measured: 6 weeks
Change from Valgus Index at 6 week.
It used to define pes planus. (Degree)
Measured: 6 weeks
Change from Navicular Drop at 6 week.
It used to define pes planus. (mm)
Measured: 6 weeks
Change from Angle of subtalar joint at 6 week.
It used to define pes planovalgus. (Degree)
Measured: 6 weeks
Change from Craig test at 6 week.
The test used for angle of hip anteversion. (Degree)
Measured: 6 weeks
Change from thigh foot angle examination at 6 week.
The test used for angle of tibial torsion. (Degree)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start19 Apr 2017
- Primary completion7 Jun 2017
- Study completion14 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burcu Talu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burcu Talu, Inonu University
- Investigators
- Burcu TALU, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151538
- Sponsor's protocol ID
- 2017-54
- Status last verified
- Aug 2017
- First submitted
- 26 Apr 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
PubMed 35080267Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
PubMed 35029841
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Effects on Pes Planus and Femoral Anteversion Angle of Exercise Training Mixed With Play on Pre-school Children
- ClinicalTrials.gov ID
- NCT03151538
- Acronym / sponsor ID
- 2017-54
- Conditions
- Pes Planus, Flat Foot, Femoral Anteversion
- Keywords
- Pedography, Exercise, Play Training, Pes Planus, Femoral Anteversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Burcu TaluUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 14 Jun 2017 (actual)
- First posted
- 12 May 2017 (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.
The study was planned to assess effects on pes planus and femoral anteversion angle of exercise training mixed with play on pre-school children.
Detailed description
Pes planus ( Pes planovalgus) is similar with flatfoot occurs collapse of medial longitudinal arch which is lower than normal range or occurs extra pressure on arch. It is separated two group such congenital (flexible and rigid) and acquired. The etiology of pes planus is that hallux rigidus, plantar calcaneonavicular ligament rupture, collapse of medial longitudinal arch, pathology of ligament and tendon, shortness Achilles tendon and juvenile hallux valgus. The most common causes of pes planus are outgroup of leg muscles (peroneal) spasticity, plantar fasciitis and tibial tendon insufficiency. Symptoms of pes planus are indicated heel pain, gait abnormalities, decreased dorsiflexion range of ankle, plantar ulceration, limited mobility of 1.metatarsophalangeal joint and spasm of peroneal muscle. There is a high prevalence rates among males and occur positive correlation between with pes planus and BMI. Evaluation methods of pes planus are X-ray, heel height, gait analysis and Achilles strain. The most commonly used method are line that medial malleolus, 1st metatarsal head and the navicula is on the same line, and the footprint technique from ink rubber plates. Treatment of pes planus is maintained medial displacement calcaneal osteotomy operation with the transfer of the flexor digitorum longus. Non- invasive treatment methods are given such as peroneal muscles and Achilles stretching exercises. 25 degree angle inverted foot orthoses are commonly used because of increasing stance phasic in treatment. Peroneal neural mobilization, play training and stretching exercises are often used treatment method of pes planus. Main purpose of this study is that assess effects of mixed training program with playing on pes planus and increased femoral anteversion angle in pre-school students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental, Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Pes Planus Group | Experimental | Behavioral: Exercise Training Mixed With PlayThis group of patients received children with pes planus. It will be applied exercise training mixed with play |
| Controlled Group | Other | Other: ControlledThis group of patients received healthy children. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children in an age range of 4-7 years,
- Having bilateral or unilateral deformity with pes planus
- CSI range > % 62.7 measured by the referring physical therapist.
- Having no any foot surgeon,
- Without any neurological diseases,
Key exclusion criteria (2 listed)
- Pre-school students who can not adapt to training,
- Students who do not want to be involved in voluntary work.
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 |
|---|---|---|
| Exercise Training Mixed With PlayTo assess effects of training program which includes mixed exercises with playing.Study included 90 pre-school children who suffer from pes planus and increased femoral anteversion angle. Demographic data, navicular height, weight-bearing and non-weight bearing of subtalar joint motion, metatarsal width(weight and non-weight), range of hallux valgus,height of foot, tension of Achilles tendon, habits of W standing(hour/day), angle of Quadriceps(Q degree), angle of hip rotation were recorded . Craig Test, foot posture index, Chippaux-Smirak Index(CSI),Beighton hypermobility score, valgus index, thigh foot angle examination were used. CSI measurements were positive correlation with severity of pes planus. | Behavioural | Pes Planus Group |
| ControlledFirst and last measurements will be done. There will be no intervention. Study will include 30 healthy pre-school children. Demographic data, navicular height, weight-bearing and non-weight bearing of subtalar joint motion, metatarsal width(weight and non-weight), range of hallux valgus,height of foot, tension of Achilles tendon, habits of W standing(hour/day), angle of Quadriceps(Q degree), angle of hip rotation were recorded . Craig Test, foot posture index, Chippaux-Smirak index(CSI),Beighton hypermobility score, valgus index, thigh foot angle examination were used. | Other | Controlled Group |
Primary outcome
Foot print with pedography (%). Change from pes planus at 6 week.
Time frame: 6 weeks
It used to define pes planus.
6 secondary outcomes
Change from Angle of Quadriceps at 6 week.
Time frame: 6 weeks
Change from Valgus Index at 6 week.
Time frame: 6 weeks
Change from Navicular Drop at 6 week.
Time frame: 6 weeks
Change from Angle of subtalar joint at 6 week.
Time frame: 6 weeks
Change from Craig test at 6 week.
Time frame: 6 weeks
Change from thigh foot angle examination at 6 week.
Time frame: 6 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 18 Aug 2017.
- Derived from this study: PubMed 35080267Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
- Derived from this study: PubMed 35029841Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
- Individual participant dataSharing planned: No
Related trials for Pes Planus
Not yet recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
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Comparing Effects of Custom Foot Orthotic Intervention to Foot-Core Training Protocol on Lower Extremity Kinematics in Runners With Pes Planus
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Immediate Effects of Plantar Fascia Release Combined With Foot Exercises on FMS Subscores in Young Adults With Pes Planus
Pes Planus, FMS
Active, not recruitingObservational study
Investigation of the Relationship Between Pes Planus and Piriformis Syndrome: A Case-Control Study
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Recruiting
Peripheral Magnetic Stimulation of Foot Muscles: Effects on Medial Longitudinal Arch Height and Foot Muscle Strength in Adults With Flat Feet
Pes Planus, Flatfoot
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.
Burcu TALU, PhD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training Mixed With Play in people with Pes Planus and Flat Foot, run by Burcu Talu at 1 site 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 7 inclusion and 2 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 18 Aug 2017. 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 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?
Foot print with pedography (%). Change from pes planus at 6 week. (time frame: 6 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 NCT03151538, which also lists 2 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 18 Aug 2017; AzTrials last refreshed its copy on 29 Oct 2026.