Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
The Effect of Custom 3D Printed Insoles and Short Foot Exercises on Foot Posture, Balance, and Gait Parameters in Individuals With Pes Planus
The primary purpose of this study is to evaluate the effects of combining custom 3D-printed medial arch-supported insoles with short foot exercises on foot posture, balance, and gait parameters in individuals with pes planus (flat feet). Furthermore, the study will investigate the impact of this combined intervention on secondary outcomes, including pain levels, health-related quality of life, and functional exercise capacity measured by the 6-Minute Walk Test.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants will be recruited through personal networks and social media platforms using a snowball sampling method. Potential candidates will be screened for pes planus in accordance with established literature protocols, utilizing the Foot Posture Index-6 (FPI-6) and the Navicular Drop Test.
Eligible individuals who meet the criteria for pes planus will undergo 3D foot scanning. Based on the obtained data, customized medial arch-supported insoles will be manufactured using 3D printing technology. Participants will be instructed to use these custom insoles in their daily lives for a total of 8 weeks. Concurrently, they will be assigned a daily short foot exercise (intrinsic muscle training) program. Each exercise repetition will involve a 5-second hold, and the entire protocol will be maintained for 8 weeks.
All clinical, functional, and biomechanical evaluations-including foot posture, dynamic balance, comprehensive gait and plantar pressure analysis (via the Zebris system), pain intensity, quality of life, and functional walking capacity-will be conducted at two time points: at baseline and at the end of the 8-week intervention period.
For statistical analysis, depending on the normality of data distribution, either a paired t-test or a Wilcoxon signed-rank test will be used to evaluate within-group changes between baseline and week 8. To determine the magnitude of the intervention effect, Cohen's d effect sizes for dependent measures will be calculated and reported alongside 95% confidence intervals.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ayse Kocak Sezgin, Phd
- Numéro de téléphone: +90 5072243706
- E-mail: ayse.kocaksezgin@ksbu.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Emrah Afsar, Phd
- Numéro de téléphone: 5062527008
- E-mail: emrah.afsar@ksbu.edu.tr
Lieux d'étude
-
-
-
Kütahya, Turquie (Türkiye)
- Recrutement
- Kutahya Health Science University
-
Contact:
- Emrah Afsar, Phd
- Numéro de téléphone: 5062527008
- E-mail: emrah.afsar@ksbu.edu.tr
-
Chercheur principal:
- Emrah Afsar, Phd
-
Sous-enquêteur:
- Zeynep Sena Namaz, MSc
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Aged between 18 and 35 years.
- Presence of pes planus, defined as a Navicular Drop test value > 10 mm and a Foot Posture Index-6 (FPI-6) score between +6 and +12.
- Willingness to volunteer for the study and provide written informed consent.
Exclusion Criteria:
- Presence of rigid pes planus.
- Hallux valgus.
- Hallux rigidus.
- Calcaneal spur (heel spur).
- History of any neurological, cardiovascular, or systemic diseases.
- History of any orthopedic disease affecting the lower extremities.
- History of lower extremity surgery.
- Body Mass Index (BMI) ≥ 30 kg/m².
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Insole and Exercise Group
All participants in this group will receive custom 3D printed insoles and perform a short foot exercise program. |
The intervention consists of a combined biomechanical and active rehabilitation approach for individuals with pes planus:
|
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 8 Weeks
|
Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated). |
Baseline and 8 Weeks
|
|
Navicular Drop Test (NDT)
Délai: Baseline and 8 Weeks
|
Assesses medial longitudinal arch height difference (in mm) between seated (non-weight bearing) and standing (weight bearing) positions. Higher values indicate increased pronation. |
Baseline and 8 Weeks
|
|
Modified Star Excursion Balance Test (MSEBT)
Délai: Baseline and 8 Weeks
|
Evaluates dynamic balance by measuring the maximum reach distance (in cm) in three directions: anterior, posteromedial, and posterolateral. |
Baseline and 8 Weeks
|
|
Spatiotemporal Gait and Plantar Pressure Parameters
Délai: Baseline and 8 Weeks
|
Evaluated using the Zebris system. Includes gait speed (m/s), cadence (steps/min), stride length (cm), stance percentage (%), and plantar pressure parameters (e.g., peak pressure, contact area). |
Baseline and 8 Weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Délai: Baseline and 8 Weeks
|
Assesses pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). |
Baseline and 8 Weeks
|
|
36-Item Short Form Health Survey (SF-36)
Délai: Baseline and 8 Weeks
|
Assesses health-related quality of life across 8 domains. Subscale scores are transformed to a 0 to 100 scale, where higher scores indicate better health status. |
Baseline and 8 Weeks
|
|
6-Minute Walk Test (6MWT) and Modified Borg Scale
Délai: Baseline and 8 Weeks
|
Evaluates functional capacity by measuring the total distance walked in 6 minutes (in meters). Perceived exertion is assessed before and after the test using the Modified Borg Scale (0-10 scale; higher scores indicate greater exertion). |
Baseline and 8 Weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Emrah Afsar, Phd, Kutahya Health Science University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
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
- 3D Insole in Pes Planus
- TDK-2026-365 (Autre subvention/numéro de financement: Kutahya Health Sciences University Scientific Research Projects Unit)
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 .