- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955039
Effects of Sand Exercise Program On Foot Posture , Navicular Drop and Dynamic Balance in Children With Pronated Foot
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The effects of sand training exercises combined with navicular drop interventions on dynamic balance and foot posture in children aged 6 to 11 years with pronated feet. Pronated foot posture, characterized by the inward rolling of the foot and a lowered medial arch, is prevalent in pediatric populations and can lead to altered gait mechanics and reduced dynamic balance. Early intervention is crucial to prevent long-term deformities and improve overall foot health. The study aims to provide evidence-based insights into the benefits of integrating proprioceptive training with specific sand exercises program targeting the navicular bone, thereby enhancing foot posture and dynamic balance in affected children.
This randomized controlled trial (RCT) will involve 20 participants divided into 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. The study will 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, with assessments conducted at baseline, 4 weeks, and 8 weeks post-intervention. This study aims to provide evidence on the effects of combining sand training with towel curl exercises for determining foot posture.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54900
- Rising Sun Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Clinical experimental: For group A each session last 50 minutes daily for 8 weeks 3 times per week during a 8-week period
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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.
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.
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Active Comparator: Group B
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
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feiss line Test
Time Frame: base line ,4th week ,8th week
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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.
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base line ,4th week ,8th week
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Foot Posture Index (FPI -6 )
Time Frame: base line ,4th week ,8th week
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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.
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base line ,4th week ,8th week
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Navicular Drop Measurement
Time Frame: base line ,4th week ,8th week
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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
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base line ,4th week ,8th week
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Dynamic Balance Assessment
Time Frame: base line ,4th week ,8th week
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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.
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base line ,4th week ,8th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eishah M Saeed, MS-PPT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- REC//RER/AHS/24/0733
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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