- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07244172
Posture du Pied et Équilibre chez les Enfants Avec des Pieds Plats Flexibles : Effets de la Marche dans la Boue
Effets de la Marche dans la Boue sur la Posture du Pied et l'Équilibre chez les Enfants Atteints de Pieds Plats Flexibles
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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 5400
- Imran Amjad
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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. |
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Foot Posture Index-6 (FPI-6)
Délai: 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)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Single Leg Hop Test
Délai: 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. |
Baseline and 6th week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Saman Maqbool, MS-PT, Riphah International University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Talipes
- Maladies musculo-squelettiques
- Anomalies musculosquelettiques
- Anomalies congénitales
- Difformités des membres inférieurs, congénitales
- Déformations des membres, congénitales
- Déformations du pied
- Déformations du pied, acquises
- Difformités du pied, congénitales
- Maladies et anomalies congénitales, héréditaires et néonatales
- Pied plat
Autres numéros d'identification d'étude
- REC/RCR&AHS/25/0701
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .