NCT03151538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

April 26, 2017

Last Update Submit

August 15, 2017

Conditions

Keywords

PedographyExercisePlay TrainingPes PlanusFemoral Anteversion

Outcome Measures

Primary Outcomes (1)

  • Foot print with pedography (%). Change from pes planus at 6 week.

    It used to define pes planus.

    6 weeks

Secondary Outcomes (6)

  • Change from Angle of Quadriceps at 6 week.

    6 weeks

  • Change from Valgus Index at 6 week.

    6 weeks

  • Change from Navicular Drop at 6 week.

    6 weeks

  • Change from Angle of subtalar joint at 6 week.

    6 weeks

  • Change from Craig test at 6 week.

    6 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Beighton Hypermobility Score

    Baseline

Study Arms (2)

Pes Planus Group

EXPERIMENTAL

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

Behavioral: Exercise Training Mixed With Play

Controlled Group

OTHER

This group of patients received healthy children.

Other: Controlled

Interventions

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.

Pes Planus Group

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.

Controlled Group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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 ).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preschool of Battalgazi and Yesilyurt district

Malatya, 44210, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

FlatfootMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Burcu TALU, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 12, 2017

Study Start

April 19, 2017

Primary Completion

June 7, 2017

Study Completion

June 14, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations