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Flexible FlatfootNCT07244172

Foot Posture and Balance in Children With Flexible Flatfeet: Effects of Mud-walk

A study testing mud-walk in people with Flexible Flatfoot, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Flexible Flatfoot
What is being tested?
mud-walk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 sitePakistan
Study dates
22 Oct 2025to 16 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Imran Amjad

    Lahore, Punjab Province, 5400

Other trials in Pakistan

About this study

Official title: Effects of Mud-walk on Foot Posture and Balance in Children With Flexible Flatfeet

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.

Read the detailed description

Flatfeet is one of the predominant conditions of feet in children and is characterized by absence of medial longitudinal arch. Flatfeet affect the foot posture by altering the entire biomechanics of musculoskeletal system of lower limb. It ultimately affects the balance and functional mobility in children and may have poor quality of life in adulthood. The strength training programs and uneven surfaces have been used previously for its intervention. The mud-walk provides natural resistance along with sensory feedback due to its soft, variable surface. The aim of this study is to determine effects of mud-walk on foot posture, balance and functional performance of lower limb in children with flexible flatfeet.

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 from Presentation Convent High School and The Sanai School Sargodha. All children will be assessed for inclusion and exclusion. 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.

Being tested
mud-walk
Keywords
Balance, Flexible Flatfoot, Foot Posture, Foot Posture Index, Navicular Drop Test, Pediatric Berg Balance Scale
Medical subject headings
Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mud-walkOther

    • 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
Study groups in NCT07244172
Study groupRoleWhat they receive
Mud trainingOtherThe 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.
Receives: Other: mud-walk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline and 6th week

  2. 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 .

    Measured: Baseline and 6th week

  3. 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) .

    Measured: Baseline and 6th week

Secondary outcomes (1)

  1. Single Leg Hop Test

    Single leg hop test assesses functional performance of lower limb. The test method involves performing a forward jump, covering the maximum possible distance with one foot, landing on the same foot, and finally maintaining balance for at least 2 seconds. After performing 2 or 3 attempts, the individual executes a complete single-leg hop with the dominant leg, and the distance covered is recorded. An intra-class correlation coefficient (ICC) of over 0.85 has been reported for the reliability of this test in various studies.

    Measured: Baseline and 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start22 Oct 2025
  3. Primary completion2 Jun 2026
  4. Study completion16 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07244172
Sponsor's protocol ID
REC/RCR&AHS/25/0701
Status last verified
Sep 2026
First submitted
17 Nov 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37240471

Questions about this trial

What is this clinical trial studying?

A study testing mud-walk in people with Flexible Flatfoot, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Foot Posture Index-6 (FPI-6) (time frame: Baseline and 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07244172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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