NCT04840017

Brief Summary

"Idiopathic flat foot is a common condition in children and adolescents. After loading, the heel is adjusted in valgus, the medial longitudinal arch of the foot flattens, and the forefoot is positioned at abducted. Such deformation can be classified as flexible or rigid. A lowered flat foot arch is an undesirable feature. Additional factors such as e.g. abnormal body weight, may have impact on the shape of medial longitudinal arch. Increasing evidence suggests that excess weight is inextricably linked to flatfoot and postural stability. In connection with consequences, disorders of the muscles responsible for stabilizing the arches of the foot are noticed. The mobility and stability of the foot arches is controlled by the internal and external muscles of the foot, but the former are often overlooked in therapy. Short foot exercises are recommended as an improvement in foot arch parameters. The participants will take part in the research with the written consent of their parents or legal guardians. The results will be used anonymously for scientific publications."

Trial Health

75
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress90%
Jan 2021Dec 2026

Study Start

First participant enrolled

January 15, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Expected
Last Updated

October 23, 2023

Status Verified

August 1, 2023

Enrollment Period

5.3 years

First QC Date

February 3, 2021

Last Update Submit

October 18, 2023

Conditions

Keywords

PlanovalgusMedial Longitudinal ArchGaitKinematicEmgWalkLocomotionMotion AnalysisLow-arched FeetValgus DeformityBalance

Outcome Measures

Primary Outcomes (8)

  • Navicular Height (NH)

    The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters.

    Baseline

  • Navicular Height (NH)

    The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters.

    6-weeks intervention

  • Navicular Height (NH)

    The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters.

    3 months later

  • Navicular Height (NH)

    The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters.

    6 months later

  • Body Mass Index (BMI)

    Each child's weight and height will be assessed to determine their BMI using the formula weight \[kg\] / height \[m\] 2. This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.

    baseline

  • Body Mass Index (BMI)

    Each child's weight and height will be assessed to determine their BMI using the formula weight \[kg\] / height \[m\] 2. This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.

    6-weeks intervention

  • Body Mass Index (BMI)

    Each child's weight and height will be assessed to determine their BMI using the formula weight \[kg\] / height \[m\] 2. This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.

    3 months later

  • Body Mass Index (BMI)

    Each child's weight and height will be assessed to determine their BMI using the formula weight \[kg\] / height \[m\] 2. This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.

    6 months later

Secondary Outcomes (24)

  • Foot Posture Index-6 (FPI-6)

    Baseline

  • Foot Posture Index-6 (FPI-6)

    6-weeks intervention

  • Foot Posture Index-6 (FPI-6)

    3 months later

  • Foot Posture Index-6 (FPI-6)

    6 months later

  • Arch Index (AI)

    baseline

  • +19 more secondary outcomes

Study Arms (3)

Study group I

EXPERIMENTAL

excessive body weight and flat feet

Other: rehabilitation exercise

Study group II

EXPERIMENTAL

normal body weight and flat feet

Other: rehabilitation exercise

Study group III

NO INTERVENTION

control, healthy children

Interventions

Rehabilitation exercise of intrinsic foot muscles

Study group IStudy group II

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- Bilateral flexible flatfeet

You may not qualify if:

  • Tarsal coalitions,
  • Congenital defects of the lower limbs,
  • Neurological diseases,
  • Previous foot surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, 80-336, Poland

Location

MeSH Terms

Conditions

Flatfoot

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2021

First Posted

April 9, 2021

Study Start

January 15, 2021

Primary Completion

April 29, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

October 23, 2023

Record last verified: 2023-08

Locations