- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07244172
Foot Posture and Balance in Children With Flexible Flatfeet: Effects of Mud-walk
Effects of Mud-walk on Foot Posture and Balance in Children With Flexible Flatfeet
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 5400
- Recruiting
- Imran Amjad
-
Contact:
- Muhmmad Asif Javed, MS
- Phone Number: 033224209422
- Email: a.javed@ripah.edu.pk
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Contact:
- Saman Maqbool, MS*
- Phone Number: 03260426215
- Email: sammaqbool215@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with bilateral flexible flat feet
- Children aged 6-11 years
- Children who are not involved in any other trial
- FPI-6 score >6
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Mud training
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.
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The main exercise phase will consist of 20 minutes of walk on mud in four manners with each manner for 5 minutes:
The cool down phase will consist of 5 minutes and will include
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot Posture Index-6 (FPI-6)
Time Frame: Baseline and 6th week
|
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:
It can be
|
Baseline and 6th week
|
|
Navicular Drop Test (NDT)
Time Frame: Baseline and 6th week
|
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)
Time Frame: Baseline and 6th week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single Leg Hop Test
Time Frame: Baseline and 6th week
|
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.
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Baseline and 6th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saman Maqbool, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Flatfoot
Other Study ID Numbers
- REC/RCR&AHS/SAMANMAQBOOL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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