Effects on Pes Planus Exercise Training Mixed With Play on Pre-school Children

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.

Study Overview

• Status: Completed
• Conditions: Flat Foot; Pes Planus; Femoral Anteversion
• Intervention / Treatment: Behavioral: Exercise Training Mixed With Play; Other: Controlled

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44210
    • Preschool of Battalgazi and Yesilyurt district

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 ).

Exclusion Criteria:

• Pre-school students who can not adapt to training,
• Students who do not want to be involved in voluntary work.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pes Planus Group; This group of patients received children with pes planus. It will be applied exercise training mixed with play	Behavioral: Exercise Training Mixed With Play; 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.
Other: Controlled Group; This group of patients received healthy children.	Other: Controlled; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot print with pedography (%). Change from pes planus at 6 week.	It used to define pes planus.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Angle of Quadriceps at 6 week.	The test used for angle of hip anteversion. (Degree)	6 weeks
Change from Valgus Index at 6 week.	It used to define pes planus. (Degree)	6 weeks
Change from Navicular Drop at 6 week.	It used to define pes planus. (mm)	6 weeks
Change from Angle of subtalar joint at 6 week.	It used to define pes planovalgus. (Degree)	6 weeks
Change from Craig test at 6 week.	The test used for angle of hip anteversion. (Degree)	6 weeks
Change from thigh foot angle examination at 6 week.	The test used for angle of tibial torsion. (Degree)	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beighton Hypermobility Score	It used to define hypermobility.(Index score)	Baseline

Collaborators and Investigators

• Sponsor: Burcu Talu
• Investigators: Principal Investigator: Burcu Talu, PhD, Inonu University

Publications and helpful links

General Publications

• Evans 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): June 7, 2017
• Study Completion (Actual): June 14, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Pedography; Play Training; Pes Planus; Femoral Anteversion
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: 2017-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No