search
Back to results

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

Primary Purpose

Pes Planus, Flat Foot, Femoral Anteversion

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Training Mixed With Play
Controlled
Sponsored by
Burcu Talu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring Pedography, Exercise, Play Training, Pes Planus, Femoral Anteversion

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Preschool of Battalgazi and Yesilyurt district

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Pes Planus Group

Controlled Group

Arm Description

This group of patients received children with pes planus. It will be applied exercise training mixed with play

This group of patients received healthy children.

Outcomes

Primary Outcome Measures

Foot print with pedography (%). Change from pes planus at 6 week.
It used to define pes planus.

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2017
Last Updated
August 15, 2017
Sponsor
Burcu Talu
search

1. Study Identification

Unique Protocol Identification Number
NCT03151538
Brief Title
Effects on Pes Planus Exercise Training Mixed With Play on Pre-school Children
Official Title
Assessment Effects on Pes Planus and Femoral Anteversion Angle of Exercise Training Mixed With Play on Pre-school Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
June 7, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Burcu Talu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus, Flat Foot, Femoral Anteversion
Keywords
Pedography, Exercise, Play Training, Pes Planus, Femoral Anteversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pes Planus Group
Arm Type
Experimental
Arm Description
This group of patients received children with pes planus. It will be applied exercise training mixed with play
Arm Title
Controlled Group
Arm Type
Other
Arm Description
This group of patients received healthy children.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training Mixed With Play
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Controlled
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot print with pedography (%). Change from pes planus at 6 week.
Description
It used to define pes planus.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from Angle of Quadriceps at 6 week.
Description
The test used for angle of hip anteversion. (Degree)
Time Frame
6 weeks
Title
Change from Valgus Index at 6 week.
Description
It used to define pes planus. (Degree)
Time Frame
6 weeks
Title
Change from Navicular Drop at 6 week.
Description
It used to define pes planus. (mm)
Time Frame
6 weeks
Title
Change from Angle of subtalar joint at 6 week.
Description
It used to define pes planovalgus. (Degree)
Time Frame
6 weeks
Title
Change from Craig test at 6 week.
Description
The test used for angle of hip anteversion. (Degree)
Time Frame
6 weeks
Title
Change from thigh foot angle examination at 6 week.
Description
The test used for angle of tibial torsion. (Degree)
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Beighton Hypermobility Score
Description
It used to define hypermobility.(Index score)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu TALU, PhD
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preschool of Battalgazi and Yesilyurt district
City
Malatya
ZIP/Postal Code
44210
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35080267
Citation
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.
Results Reference
derived
PubMed Identifier
35029841
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs