NCT07578974

Brief Summary

This study investigates flexible pes planus (flat feet) in children, a condition where the medial arch collapses during weight-bearing, affecting gait, balance, and foot function. Although foot-core strengthening and visual feedback individually improve arch stability and motor control, their combined effect in pediatric populations remains underexplored. To address this gap, a randomized controlled trial will be conducted at Rafia Grammar School, involving 24 children aged 7-12 years with clinically confirmed flexible pes planus. Participants will be randomly assigned into two groups: one receiving foot-core training alone and the other receiving foot-core training with visual feedback, with interventions carried out twice weekly for 8 weeks. Changes in foot posture and gait will be assessed using standardized outcome measures, and data will be analyzed using SPSS version 23.0. The study aims to determine whether adding visual feedback enhances treatment effectiveness and supports the development of more targeted, evidence-based pediatric rehabilitation strategies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress29%
Apr 2026Aug 2026

Study Start

First participant enrolled

April 13, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

Pes PlanusGaitVisual feedbackFoot-core trainingPediatrics

Outcome Measures

Primary Outcomes (9)

  • Foot Posture Index

    The Foot Posture Index-6 (FPI-6) is a reliable and valid tool for pediatric foot assessment, with excellent inter-rater (ICC 0.92-0.97) and test-retest reliability (ICC 0.93-0.95). It shows good validity through correlations with radiographic measures (r = 0.37-0.77) and demonstrates strong diagnostic accuracy for flexible flatfoot (AUC 0.82, sensitivity 83.7%, specificity 80.4), supporting its clinical and research use.

    Baseline, 8 weeks

  • Temporal Distance Gait Analysis:

    Temporal-distance gait analysis using footprint methods is a valid and reliable tool for assessing pediatric gait. It measures parameters like step length, stride width, and cadence via footprints on a marked walkway. Studies show good test-retest reliability (ICCs 0.52-0.98), supporting its use in children with gait abnormalities, including flexible pes planus.

    Baseline, 8 weeks

  • Arch Height Index

    The Arch Height Index (AHI) is a reliable and valid measure of pediatric foot structure. It shows strong intra- and inter-rater reliability (ICC ≥ 0.76-0.90) in both sitting and standing positions. Evidence supports its precision and consistency for assessing foot posture in children.

    Baseline, 8 weeks

  • Medial Longitudinal Arch Angle

    The Medial Longitudinal Arch (MLA) angle is a reliable and valid clinical measure for assessing pediatric foot posture. It shows excellent intra-rater (ICC 0.88-0.90) and inter-rater (ICC 0.80-0.85) reliability in children aged 6-12 years. It is a simple, non-invasive tool that accurately reflects arch structure and is useful for evaluating flexible flatfoot.

    Baseline, 8 weeks

  • Calcaneal Eversion Angle

    The Calcaneal Eversion Angle is a reliable clinical measure for assessing rearfoot position in weight-bearing stance. It shows good intra-rater reliability (ICC = 0.84) with consistent repeated measurements, and acceptable inter-rater reliability. Overall, it is a valid and practical tool for evaluating foot posture in both children and adults.

    Baseline, 8 weeks

  • Subtalar joint range of motion

    The subtalar joint ROM, assessed via goniometry in weight- or non-weight-bearing positions, is a reliable and valid measure in children. It shows good intra-rater reliability (ICC 0.74-0.90) and acceptable inter-rater reliability (ICC \~0.50-0.72). Overall, it is a clinically practical tool for evaluating foot and ankle mobility in pediatric populations.

    Baseline, 8 weeks

  • Footprint Index (Staheli or Chippaux):

    The Staheli Index (SI) and Chippaux-Smirak Index (CSI) are reliable footprint-based tools for detecting pediatric flatfoot. They show excellent intra-rater (ICC 0.92-0.99) and good inter-rater reliability (ICC 0.79-0.96), with low measurement error (SEM 0.08-0.21, MDC 0.22-0.59). Both demonstrate strong validity through correlations with radiographic arch measures (r = 0.66-0.79).

    Baseline, 8 weeks

  • Y-Balance Test

    The Y-Balance Test (YBT-LQ) is a reliable and valid measure of dynamic balance in children. It shows excellent inter-rater (ICC 0.84-0.92) and test-retest reliability (ICC 0.81-0.92), with low SEM (1.80%-3.10%) and MDC (4.98%-8.60%). These findings confirm its sensitivity and clinical usefulness for assessing dynamic postural control in pediatric populations.

    Baseline, 8 weeks

  • Lower Extremity Functional Scale

    The Lower Extremity Functional Scale (LEFS) is a reliable and valid patient-reported tool for assessing lower limb function in children and adolescents. It shows excellent internal consistency (Cronbach's α = 0.972) and strong construct validity. It also correlates highly with pediatric quality of life measures (r = 0.859).

    Baseline, 8 weeks

Other Outcomes (6)

  • Tiptoe standing test

    Baseline

  • Jack's test

    Baseline

  • Navicular Drop Test

    Baseline

  • +3 more other outcomes

Study Arms (2)

Group A: Experiment Group 1: Foot-Core Training group

ACTIVE COMPARATOR

Children will perform the following exercises 2 times per week for 8 weeks, with daily practice encouraged at home. Start with 1-2 sets of 5-15 repetitions, holding each for 5-10 seconds, with 1-2 minutes rest between sets. Progress by increasing repetitions or hold durations gradually (7). The session will take 30-45 mins.

Other: Foot Core Training

Group B: Experiment Group 2: Foot-Core Training with Visual Feedback group

ACTIVE COMPARATOR

Visual feedback will be provided using mirror therapy with a mirror box (36 × 36 × 48 cm). The child will sit comfortably with the mirror placed at the midline between the legs; one foot will be hidden inside the box while the other remains visible in front of the mirror. As the child performs foot-core exercises with the visible foot, the mirror creates the illusion that both feet are moving symmetrically, enhancing motor learning through visual feedback. The procedure will then be repeated by switching foot positions to ensure bilateral training. Exercises will be performed twice weekly for 8 weeks, with additional home practice encouraged. Each session will last 30-45 minutes, starting with 1-2 sets of 5-15 repetitions (holding each for 5-10 seconds) and progressing gradually with rest intervals of 1-2 minutes between sets.

Other: Foot Core Training with Visual Feedback

Interventions

Visual feedback will be delivered via mirror therapy using a 36×36×48 cm mirror box. The child sits with the mirror at midline; one foot is hidden inside the box while the other is visible. While performing foot-core exercises, the mirror creates the illusion of symmetrical movement. The process is repeated by switching feet to ensure bilateral training. Exercises will be done 2×/week for 8 weeks (home practice encouraged), 1-2 sets of 5-15 reps (hold 5-10 sec), 1-2 min rest, session 30-45 min. 1. Short-Foot: Lift arch without toe curling (5-15 reps) 2. Heel Raises: Tip-toe, hold 2 sec (15 reps) 3. Towel Scrunch: Toe curl (\~1 min) 4. Marble Pickup: Pick/place objects (\~1 min) 5. Arch Lift: Standing arch raise (15 reps) 6. Plantar Roll + Stretch: Ball roll + calf stretch (15-30 sec ×2-3) 7. Toe Spread/Squeeze: Improves foot stability

Also known as: Short Foot Eercises with Visual Feedback
Group B: Experiment Group 2: Foot-Core Training with Visual Feedback group

Children will perform exercises 2×/week for 8 weeks with daily home practice. Begin with 1-2 sets of 5-15 reps (hold 5-10 sec), 1-2 min rest, progressing gradually. Session: 30-45 min. 1. Short-Foot Contraction: Lift medial arch without toe curling (5-15 reps, hold 5-10 sec) 2. Tip-Toe Heel Raises: Rise, hold 2 sec, lower (15 reps) 3. Towel Scrunch: Scrunch towel with toes (\~1 min) 4. Marble Pickup: Pick/place objects with toes (\~1 min) 5. Arch Lifting: Lift arch in standing (15 reps) 6. Plantar Roll + Calf Stretch: Ball roll + stretch (15-30 sec ×2-3) 7. Toe Spread \& Squeeze: Spread and squeeze toes

Also known as: Short Foot exercises
Group A: Experiment Group 1: Foot-Core Training group

Eligibility Criteria

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

You may qualify if:

  • Children aged 7-12 years with confirmed flat feet
  • Both Genders
  • Flexibility of flatfeet; tested using Tip toe standing test and Jack's test.
  • Navicular Drop (\>10mm)
  • Mini Mental State Examination score \> 21
  • Visual acuity of 20/40 (6/12) or better in both eyes, confirmed by Snellen chart test.
  • Foot Posture Index-6 (FPI-6, \> +6)
  • Children demonstrate altered gait parameters consistent with flexible pes planus as measured by temporal-distance gait analysis.
  • Arch Height Index (\< 0.31)
  • Medial Longitudinal Arch Angle (\<130°)
  • Calcaneal Eversion Angle ( \>5° eversion)
  • Subtalar ROM (Dorsiflexion \<10°)
  • Footprint Index (Staheli \>1.0 or Chippaux \>45%)
  • Dynamic Balance; Y-Balance Test (\<85% composite score)
  • Functional Scale (LEFS) (\<60%)

You may not qualify if:

  • Children with tarsal coalitions
  • Congenital defects of lower limbs
  • Previous foot surgery
  • Foot/ankle trauma within the last six (6) months
  • Received balance training or feet muscle strengthening within the last 3 months
  • Visual and vestibular disturbance
  • A history of head injury within the last 3 months
  • Weakness of lower extremities (Manual Muscle testing grade \<5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafia Grammar School

Lahore, Punjab Province, 53700, Pakistan

RECRUITING

Related Publications (1)

  • Salinas-Torres VM, Salinas-Torres RA, Carranza-Garcia LE, Herrera-Orozco J, Tristan-Rodriguez JL. Prevalence and Clinical Factors Associated With Pes Planus Among Children and Adults: A Population-Based Synthesis and Systematic Review. J Foot Ankle Surg. 2023 Sep-Oct;62(5):899-903. doi: 10.1053/j.jfas.2023.05.007. Epub 2023 Jun 5.

    PMID: 37286098BACKGROUND

MeSH Terms

Conditions

Flatfoot

Interventions

Feedback, Sensory

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)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Officials

  • Hafiza Syeda Javeria Fayyaz, MS-PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS-PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocol and possible efforts will be put to mask both group about the treatment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This randomized controlled trial will be conducted at Rafia Grammar School. Using a convenience sampling technique, children aged 7-12 years with clinically confirmed flexible pes planus will be recruited based on predefined inclusion and exclusion criteria, including cognitive readiness and flexibility of the medial arch. After baseline assessment, participants will be randomly allocated into two intervention groups (n1=12, n2=12): one receiving foot-core training alone, and the other receiving foot-core training with visual feedback. The intervention will be performed 2 times per week for 8 weeks. The study will assess changes in gait and foot posture using standardized physical and functional outcome measures. Ethical approval will be secured before starting the study, and all evaluations will be carried out consistently throughout the trial. Data will be analyzed through SPSS version 23.0.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations