NCT07244172

Brief Summary

The study will be a quasi-experimental study with a pre-post study design. 37 children with bilateral flexible flatfeet of age 6-11 years will be recruited by non-probability convenience sampling with pre and post assessment. The navicular height, foot posture, balance and functional performance of lower limb will be assessed through Navicular Drop Test, Foot Posture Index-6, Pediatric Berg Balance Scale and Single Leg Hop Test respectively. All recruited children will receive intervention for 30 minutes a day for 3 days a week for total 6 weeks. The exercise program will include warm up phase, walk on mud and cool down phase. Data will be analyzed through SPSS version 27.0.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Oct 2025

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 Progress83%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 22, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

BalanceFlexible FlatfootFoot PostureFoot Posture IndexNavicular Drop TestPediatric Berg Balance Scale

Outcome Measures

Primary Outcomes (3)

  • Foot Posture Index-6 (FPI-6)

    FPI-6 is a clinical tool for quantifying foot positioning that uses established criteria. The FPI consists of the following six items, each graded on a scale of -2 to +2 referring to the position of the forefoot, midfoot and hindfoot, and the three planes of motion: 1. talar head palpation; 2. symmetry of supra and infra lateral malleolar curvature; 3. inversion/eversion of the calcaneus; 4. prominence in the region of the talus-navicular joint; 5. height of the medial longitudinal arch; 6. abduction/adduction of the forefoot. The FPI thus obtained ranges from -12 (highly supinated) to +12 (highly pronated). It can be * highly pronated (+10 to +12) * pronated (+6 to +9) * normal (0 to +5) * supinated (-1 to -4) * highly supinated (-5 to -12). FPI-6 demonstrates a perfect weighted kappa value (Kw = 0.86), with a high intra-rater reliability (ICC = 0.96)

    Baseline and 6th week

  • Navicular Drop Test (NDT)

    Navicular Drop Test is used to evaluate the amount of foot pronation. It is considered as a reliable and valid tool to measure static navicular height. The navicular height is measured while the child is sitting with barefoot flat on a platform with 90◦ knee flexion and the subtalar joint in neutral position. The Navicular drop is recorded as the difference in navicular height between subtalar joint neutral position and relaxed standing. Navicular drop more than 9 mm represented a pronated foot type, 5-9 mm a neutral foot and less than 5 mm a supinated foot. This test's intra-rater and inter-rater reliability has been demonstrated to range from 0.73 to 0.96 .

    Baseline and 6th week

  • Pediatric Berg Balance Scale (PBBS)

    A 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population. Each item level scores range from 0-4 which is determined by the ability to perform the assessed activity. Maximum score = 56 points with 56 points being a perfect score. Test-retest (ICC2,1 = 0.923), interrater (ICC2,1 = 0.972), and intra-rater (ICC2,1 = 0.895-0.998) are reliabilities of PBS. It has high internal consistency (Cronbach α = 0.94) .

    Baseline and 6th week

Secondary Outcomes (1)

  • Single Leg Hop Test

    Baseline and 6th week

Study Arms (1)

Mud training

OTHER

The children will walk on within a rectangular boundary of "2 × 8 dimension" (2 feet by 8 feet) with 5 cm depth. The exercise program will have 3 phases: warm up, walk on mud and cool down. The warm up phase will consist of stretching of the hamstring muscles using the static technique. The main exercise program will include walk on mud in four manners and progression will be added after 3 weeks.

Other: mud-walk

Interventions

* The participants will walk on the mud within a rectangular boundary of "2 × 8 dimension" (2 feet by 8 feet) with 5 cm depth. * The exercise program will have 3 phases: warm up, walk on mud and cool down. * The warm up phase will consist of stretching of the hamstring muscles using the static technique. The main exercise phase will consist of 20 minutes of walk on mud in four manners with each manner for 5 minutes: 1. forward walk 2. back ward walk 3. sideways walk 4. S-shaped or figure-eight walk After 3 weeks, while walking in each manner the participants will pick up small objects (soft balls) with toes from mud and place them elsewhere. The cool down phase will consist of 5 minutes and will include * soaking feet in water * washing with soap * rinsing with clean water, * drying with towel * application of emollient

Mud training

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with bilateral flexible flat feet
  • Children aged 6-11 years
  • Children who are not involved in any other trial
  • FPI-6 score \>6

You may not qualify if:

  • Children with rigid flatfeet
  • Prior foot or ankle surgery
  • Pain in lower extremities
  • Overweight or obese
  • Any other foot deformities
  • Any neurological or neuromuscular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

Related Publications (1)

  • Markowicz M, Skrobot W, Labuc A, Poszytek P, Orlikowska A, Perzanowska E, Krasowska K, Drewek K, Kaczor JJ. The Rehabilitation Program Improves Balance Control in Children with Excessive Body Weight and Flat Feet by Activating the Intrinsic Muscles of the Foot: A Preliminary Study. J Clin Med. 2023 May 9;12(10):3364. doi: 10.3390/jcm12103364.

    PMID: 37240471BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

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

Study Officials

  • Saman Maqbool, 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
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This quasi-experimental study aims to determine effects of mud-walk on foot posture and balance in children with flexible flatfeet. The study will involve 37 children with bilateral flexible flatfeet of age 6-11 years. The navicular height, foot posture, balance and functional performance of lower limb will be assessed through Navicular Drop Test, Foot Posture Index-6, Pediatric Berg Balance Scale and Single Leg Hop Test respectively. All recruited children will receive intervention for 30 minutes a day for 3 days a week for total 6 weeks. The exercise program will include warm up phase, walk on mud and cool down phase.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

October 22, 2025

Primary Completion (Estimated)

June 2, 2026

Study Completion (Estimated)

June 16, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations