- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07578974
Foot-Core Training With/Without Visual Feedback in Pediatric FPP
Comparison of Foot-Core Training With and Without Visual Feedback on Gait and Foot Posture in Children With Flexible Pes Planus
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Flexible pes planus, commonly observed in children, is characterized by a collapse of the medial longitudinal arch during weight-bearing, which can impair gait efficiency, balance, and foot function if unaddressed. While intrinsic foot muscle (foot-core) strengthening has been shown to improve arch stability and functional outcomes, and visual feedback is recognized for enhancing motor control through real-time sensory input, current literature lacks empirical evidence on the combined effect of these interventions in pediatric flatfoot populations.
Most studies examine either strengthening exercises or feedback mechanisms independently, often without tailoring protocols to the unique neuromuscular learning needs of children. This gap limits the development of comprehensive rehabilitation strategies for flexible pes planus. Therefore, this study aims to compare the effectiveness of foot-core training with and without visual feedback on foot posture and gait parameters in children with flexible pes planus, thereby contributing to the advancement of targeted, evidence-based pediatric rehabilitation approaches. This randomized controlled trial will be conducted at Rafia Grammar School. Using a convenience sampling technique, children aged 7-12 years with clinically confirmed flexible pes planus will be recruited based on predefined inclusion and exclusion criteria, including cognitive readiness and flexibility of the medial arch. After baseline assessment, participants will be randomly allocated into two intervention groups (n1=12, n2=12): one receiving foot-core training alone, and the other receiving foot-core training with visual feedback. The intervention will be performed 2 times per week for 8 weeks. The study will assess changes in gait and foot posture using standardized physical and functional outcome measures. Ethical approval will be secured before starting the study, and all evaluations will be carried out consistently throughout the trial. Data will be analyzed through SPSS version 23.0.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: IMRAN AMJAD, PhD
- Telefonní číslo: 9233224390125
- E-mail: imran.amjad@riphah.edu.pk
Studijní záloha kontaktů
- Jméno: Muhammad Asif Javed, MS-PT
- Telefonní číslo: 923224209422
- E-mail: a.javed@riphah.edu.pk
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 53700
- Nábor
- Rafia Grammar School
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Kontakt:
- IMRAN AMJAD, PhD
- Telefonní číslo: 9233224390125
- E-mail: imran.amjad@riphah.edu.pk
-
Kontakt:
- Muhammad Asif Javed, MS-PT
- Telefonní číslo: 923224209422
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Children aged 7-12 years with confirmed flat feet
- Both Genders
- Flexibility of flatfeet; tested using Tip toe standing test and Jack's test.
- Navicular Drop (>10mm)
- Mini Mental State Examination score > 21
- Visual acuity of 20/40 (6/12) or better in both eyes, confirmed by Snellen chart test.
- Foot Posture Index-6 (FPI-6, > +6)
- Children demonstrate altered gait parameters consistent with flexible pes planus as measured by temporal-distance gait analysis.
- Arch Height Index (< 0.31)
- Medial Longitudinal Arch Angle (<130°)
- Calcaneal Eversion Angle ( >5° eversion)
- Subtalar ROM (Dorsiflexion <10°)
- Footprint Index (Staheli >1.0 or Chippaux >45%)
- Dynamic Balance; Y-Balance Test (<85% composite score)
- Functional Scale (LEFS) (<60%)
Exclusion Criteria:
- Children with tarsal coalitions
- Congenital defects of lower limbs
- Previous foot surgery
- Foot/ankle trauma within the last six (6) months
- Received balance training or feet muscle strengthening within the last 3 months
- Visual and vestibular disturbance
- A history of head injury within the last 3 months
- Weakness of lower extremities (Manual Muscle testing grade <5)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Group A: Experiment Group 1: Foot-Core Training group
Children will perform the following exercises 2 times per week for 8 weeks, with daily practice encouraged at home.
Start with 1-2 sets of 5-15 repetitions, holding each for 5-10 seconds, with 1-2 minutes rest between sets.
Progress by increasing repetitions or hold durations gradually (7).
The session will take 30-45 mins.
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Children will perform exercises 2×/week for 8 weeks with daily home practice. Begin with 1-2 sets of 5-15 reps (hold 5-10 sec), 1-2 min rest, progressing gradually. Session: 30-45 min.
Ostatní jména:
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Aktivní komparátor: Group B: Experiment Group 2: Foot-Core Training with Visual Feedback group
Visual feedback will be provided using mirror therapy with a mirror box (36 × 36 × 48 cm).
The child will sit comfortably with the mirror placed at the midline between the legs; one foot will be hidden inside the box while the other remains visible in front of the mirror.
As the child performs foot-core exercises with the visible foot, the mirror creates the illusion that both feet are moving symmetrically, enhancing motor learning through visual feedback.
The procedure will then be repeated by switching foot positions to ensure bilateral training.
Exercises will be performed twice weekly for 8 weeks, with additional home practice encouraged.
Each session will last 30-45 minutes, starting with 1-2 sets of 5-15 repetitions (holding each for 5-10 seconds) and progressing gradually with rest intervals of 1-2 minutes between sets.
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Visual feedback will be delivered via mirror therapy using a 36×36×48 cm mirror box. The child sits with the mirror at midline; one foot is hidden inside the box while the other is visible. While performing foot-core exercises, the mirror creates the illusion of symmetrical movement. The process is repeated by switching feet to ensure bilateral training. Exercises will be done 2×/week for 8 weeks (home practice encouraged), 1-2 sets of 5-15 reps (hold 5-10 sec), 1-2 min rest, session 30-45 min.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Foot Posture Index
Časové okno: Baseline, 8 weeks
|
The Foot Posture Index-6 (FPI-6) is a reliable and valid tool for pediatric foot assessment, with excellent inter-rater (ICC 0.92-0.97)
and test-retest reliability (ICC 0.93-0.95).
It shows good validity through correlations with radiographic measures (r = 0.37-0.77)
and demonstrates strong diagnostic accuracy for flexible flatfoot (AUC 0.82, sensitivity 83.7%, specificity 80.4), supporting its clinical and research use.
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Baseline, 8 weeks
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Temporal Distance Gait Analysis:
Časové okno: Baseline, 8 weeks
|
Temporal-distance gait analysis using footprint methods is a valid and reliable tool for assessing pediatric gait.
It measures parameters like step length, stride width, and cadence via footprints on a marked walkway.
Studies show good test-retest reliability (ICCs 0.52-0.98),
supporting its use in children with gait abnormalities, including flexible pes planus.
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Baseline, 8 weeks
|
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Arch Height Index
Časové okno: Baseline, 8 weeks
|
The Arch Height Index (AHI) is a reliable and valid measure of pediatric foot structure.
It shows strong intra- and inter-rater reliability (ICC ≥ 0.76-0.90) in both sitting and standing positions.
Evidence supports its precision and consistency for assessing foot posture in children.
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Baseline, 8 weeks
|
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Medial Longitudinal Arch Angle
Časové okno: Baseline, 8 weeks
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The Medial Longitudinal Arch (MLA) angle is a reliable and valid clinical measure for assessing pediatric foot posture.
It shows excellent intra-rater (ICC 0.88-0.90)
and inter-rater (ICC 0.80-0.85)
reliability in children aged 6-12 years.
It is a simple, non-invasive tool that accurately reflects arch structure and is useful for evaluating flexible flatfoot.
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Baseline, 8 weeks
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Calcaneal Eversion Angle
Časové okno: Baseline, 8 weeks
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The Calcaneal Eversion Angle is a reliable clinical measure for assessing rearfoot position in weight-bearing stance.
It shows good intra-rater reliability (ICC = 0.84) with consistent repeated measurements, and acceptable inter-rater reliability.
Overall, it is a valid and practical tool for evaluating foot posture in both children and adults.
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Baseline, 8 weeks
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Subtalar joint range of motion
Časové okno: Baseline, 8 weeks
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The subtalar joint ROM, assessed via goniometry in weight- or non-weight-bearing positions, is a reliable and valid measure in children.
It shows good intra-rater reliability (ICC 0.74-0.90)
and acceptable inter-rater reliability (ICC ~0.50-0.72).
Overall, it is a clinically practical tool for evaluating foot and ankle mobility in pediatric populations.
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Baseline, 8 weeks
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Footprint Index (Staheli or Chippaux):
Časové okno: Baseline, 8 weeks
|
The Staheli Index (SI) and Chippaux-Smirak Index (CSI) are reliable footprint-based tools for detecting pediatric flatfoot.
They show excellent intra-rater (ICC 0.92-0.99)
and good inter-rater reliability (ICC 0.79-0.96),
with low measurement error (SEM 0.08-0.21,
MDC 0.22-0.59).
Both demonstrate strong validity through correlations with radiographic arch measures (r = 0.66-0.79).
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Baseline, 8 weeks
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Y-Balance Test
Časové okno: Baseline, 8 weeks
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The Y-Balance Test (YBT-LQ) is a reliable and valid measure of dynamic balance in children.
It shows excellent inter-rater (ICC 0.84-0.92)
and test-retest reliability (ICC 0.81-0.92),
with low SEM (1.80%-3.10%)
and MDC (4.98%-8.60%).
These findings confirm its sensitivity and clinical usefulness for assessing dynamic postural control in pediatric populations.
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Baseline, 8 weeks
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Lower Extremity Functional Scale
Časové okno: Baseline, 8 weeks
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The Lower Extremity Functional Scale (LEFS) is a reliable and valid patient-reported tool for assessing lower limb function in children and adolescents.
It shows excellent internal consistency (Cronbach's α = 0.972) and strong construct validity.
It also correlates highly with pediatric quality of life measures (r = 0.859).
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Baseline, 8 weeks
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Tiptoe standing test
Časové okno: Baseline
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The Tiptoe Standing Test is a valid clinical tool for differentiating flexible from rigid pes planus, based on reformation of the medial longitudinal arch during tiptoe stance.
It shows good reliability, with intra-rater ICC 0.80-0.90
and inter-rater ICC 0.70-0.85.
Despite some observer variability, it remains a practical and efficient pediatric screening method.
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Baseline
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Jack's test
Časové okno: Baseline
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Jack's Test (Hubscher Maneuver) assesses medial arch flexibility and windlass mechanism function for diagnosing flexible flatfoot.
It shows excellent intra-rater reliability (ICC 0.85-0.92)
and moderate to high inter-rater reliability (ICC 0.75-0.88),
especially with trained examiners.
It also correlates well with radiographic measures, making it a valid tool for distinguishing structural vs functional deformities in children.
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Baseline
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Navicular Drop Test
Časové okno: Baseline
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The Navicular Drop (ND) Test is used to assess medial arch flexibility and confirm flexible flatfoot.
It measures the change in navicular height from non-weight bearing to weight bearing, with >10 mm indicating flexible flatfoot.
It shows acceptable reliability (ICC 0.61-0.79)
and is a valid measure of medial arch function.
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Baseline
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Mini-Mental State Examination
Časové okno: Baseline
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The Mini-Mental State Examination (MMSE) is a well-established cognitive screening tool with strong validity and reliability.
It shows good construct and criterion validity, correlating well with full neuropsychological assessments.
It also demonstrates high test-retest reliability (r = 0.80-0.89)
and strong inter-rater reliability (ICC ≈ 0.75).
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Baseline
|
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Snellen Visual Acuity Test
Časové okno: Baseline
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The Snellen Visual Acuity Test is a standardized measure of distance vision in children, performed at 6 meters using optotypes.
It demonstrates high reliability (ICC 0.89-0.94)
and strong validity with clinical vision assessments.
It also shows good diagnostic accuracy for refractive errors, with sensitivity of 80%-92% and specificity of 85%-94%.
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Baseline
|
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Manual Muscle testing
Časové okno: Baseline
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Manual Muscle Testing (MMT) shows good validity and excellent intra-rater reliability (ICC ≈ 0.99), particularly when performed by trained clinicians.
Inter-rater reliability is variable (ICC 0.37-0.87),
depending on examiner consistency and standardization.
With experienced assessors, reliability can be very high (ICC up to 0.984), making it a useful clinical tool when properly applied.
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Baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Hafiza Syeda Javeria Fayyaz, MS-PT, Riphah International University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Talipes
- Nemoci pohybového aparátu
- Muskuloskeletální abnormality
- Vrozené vady
- Deformace dolních končetin, vrozené
- Deformace končetin, vrozené
- Deformace chodidla
- Deformace chodidla, získané
- Deformace chodidla, vrozené
- Vrozené, dědičné a neonatální nemoci a abnormality
- Plochá noha
- Fyziologické jevy
- Terapie chování
- Psychoterapie
- Disciplíny a činnosti chování
- Biofeedback, psychologie
- Zpětná vazba, psychologická
- Zpětná vazba, fyziologická
- Homeostáza
- Zpětná vazba, senzorická
Další identifikační čísla studie
- REC/RCR&AHS/HAFIZASYEDAJAVERIA
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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