NCT06955039

Brief Summary

This randomized controlled trial investigates the effects of combining sand training with navicular drop interventions on foot posture and dynamic balance in children aged 6-11 with pronated feet. Pronated foot posture, marked by inward foot rolling and a lowered arch, can impair gait and balance. Early intervention is key to preventing long-term issues. Twenty participants will be divided into experimental and control groups. Over eight weeks, the experimental group will perform sand and towel curl exercises, while the control group will do towel curls only. Foot posture, navicular drop, and balance will be assessed using the FPI-6, Navicular Drop Test, Y Balance Test, and Feiss Line Test at baseline, 4 weeks, and 8 weeks. The study aims to evaluate the added benefits of sand training in improving pediatric foot health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

April 24, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

Pronated footsand exercise programnavicular dropfoot posture

Outcome Measures

Primary Outcomes (4)

  • Feiss line Test

    The Feiss Line Test assesses the medial longitudinal arch by drawing a line from the medial malleolus to the first metatarsophalangeal joint. The navicular tuberosity should lie on or near this line; displacement below indicates arch lowering. A perpendicular distance from the navicular to this line is measured-positive if above, negative if below. The test shows high reliability, with inter-tester ICC of 0.94 and intra-tester ICC of 0.91, indicating consistent measurements across and within testers.

    base line ,4th week ,8th week

  • Foot Posture Index (FPI -6 )

    Foot posture is assessed using the Foot Posture Index (FPI-6) with the subject barefoot in a relaxed standing position. It evaluates six criteria across the forefoot, midfoot, and hindfoot, including talar head palpation, malleolar curvature, calcaneal position, talonavicular prominence, medial arch height, and forefoot alignment. Scores range from -12 (highly supinated) to +12 (highly pronated). The FPI-6 is a quick, simple, and reliable tool, showing strong intra-rater reliability (ICC 0.81-0.92) and good inter-rater reliability (ICC 0.69), especially in pediatric assessments.

    base line ,4th week ,8th week

  • Navicular Drop Measurement

    The Navicular Drop Test (NDT) measures foot pronation by comparing navicular height in a seated subtalar neutral position to its height in relaxed standing. It shows moderate to good intra-rater reliability, with ICC values ranging from 0.61 to 0.79, making it a useful clinical tool for assessing pronation

    base line ,4th week ,8th week

  • Dynamic Balance Assessment

    The Star Balance Test (or Y-Balance Test) assesses dynamic balance by having participants reach in three directions-anterior, posteromedial, and posterolateral-while balancing on one foot. The test is performed clockwise for the right foot and counterclockwise for the left. Reach distance is recorded, and errors require a retest. It shows good interrater reliability with ICC values of 0.80-0.85 and a standard error of 3.1-4.2 cm.

    base line ,4th week ,8th week

Study Arms (2)

Group A

EXPERIMENTAL

Clinical experimental: For group A each session last 50 minutes daily for 8 weeks 3 times per week during a 8-week period

Other: Sand ActivitesOther: Towel Curl Exercises

Group B

ACTIVE COMPARATOR

Clinical experimental: For group B each session lasted for 5 minutes. The exercise was performed in three sets per week, with each set lasting 5 minutes. Participants performed the exercise 20-25 times for 8 weeks

Other: Sand ActivitesOther: (TCE)

Interventions

(TCE)OTHER

The control group will only perform towel curl exercises In Week 1-4 the exercises will conducted without weights while in weeks 5-8 the exercise included the use of dumbbells weighing 2kg.this exercises will conducted in a sitting position on a slick surface.

Group B

Exercises included walking, jogging, striding, bounding, galloping, and short sprints.Exercise intensity (running speed) was controlled using a stopwatch and predefined running distances on the sand-based exercise court.

Group AGroup B

The experimental group will perform Towel Curl Exercises Sand .In Week 1-4 the exercises will conducted without weights while in weeks 5-8 the exercise included the use of dumbbells weighing 2kg.this exercises will conducted in a sitting position on a slick surface.

Group A

Eligibility Criteria

Age6 Years - 11 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged \[6-11\] years with bilateral pronated feet.
  • Both gender
  • No recent foot injury or lower extremity pain from last six months
  • Has no history of foot and ankle surgery lifetime
  • All eligible children were assessed with the Feiss line method

You may not qualify if:

  • the presence of pain in the foot at the time of physical examination
  • injury to the lower limbs, such as musculoskeletal injuries, during the previous 6 months congenital structural abnormalities, cerebral palsy, motor dysfunction prior surgery affecting the foot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising Sun Institute

Lahore, Punjab Province, 54900, Pakistan

Location

Related Publications (1)

  • Alam F, Raza S, Moiz JA, Bhati P, Anwer S, Alghadir A. Effects of selective strengthening of tibialis posterior and stretching of iliopsoas on navicular drop, dynamic balance, and lower limb muscle activity in pronated feet: A randomized clinical trial. Phys Sportsmed. 2019 Sep;47(3):301-311. doi: 10.1080/00913847.2018.1553466. Epub 2018 Dec 5.

    PMID: 30517043BACKGROUND

Study Officials

  • Eishah M Saeed, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized controlled trial (RCT) perfomed in which 20 participants divided into 2 groups an experimental group and a control group to assess the effects of an 8-week exercise program on foot health in children with pronated feet. The experimental group will perform sand activities and towel curl exercises three times a week, while the control group will only perform towel curl exercises. Pre values were taken at 1st week and then after 4th week mid values of interventions will be taken and post values of intervention will be taken after 8th week of intervention to measure foot posture, navicular drop, and dynamic balance using the Foot Posture Index (FPI-6), Navicular Drop Test, Y Balance Test, and Feiss Line Test.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 2, 2025

Study Start

April 17, 2025

Primary Completion

June 17, 2025

Study Completion

June 18, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations