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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ayse Kocak Sezgin, Phd
- Telefonnummer: +90 5072243706
- E-post: ayse.kocaksezgin@ksbu.edu.tr
Studer Kontakt Backup
- Navn: Emrah Afsar, Phd
- Telefonnummer: 5062527008
- E-post: emrah.afsar@ksbu.edu.tr
Studiesteder
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Kütahya, Tyrkia (Türkiye)
- Rekruttering
- Kutahya Health Science University
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Ta kontakt med:
- Emrah Afsar, Phd
- Telefonnummer: 5062527008
- E-post: emrah.afsar@ksbu.edu.tr
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Hovedetterforsker:
- Emrah Afsar, Phd
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Underetterforsker:
- Zeynep Sena Namaz, MSc
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Foot Posture Index-6 (FPI-6)
Tidsramme: Baseline and 8 Weeks
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Assesses foot posture across 6 criteria. Total scores range from -12 (highly supinated) to +12 (highly pronated). |
Baseline and 8 Weeks
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Navicular Drop Test (NDT)
Tidsramme: 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
|
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Modified Star Excursion Balance Test (MSEBT)
Tidsramme: 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
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Spatiotemporal Gait and Plantar Pressure Parameters
Tidsramme: Baseline and 8 Weeks
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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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Tidsramme: Baseline and 8 Weeks
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Assesses pain intensity on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). |
Baseline and 8 Weeks
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36-Item Short Form Health Survey (SF-36)
Tidsramme: Baseline and 8 Weeks
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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
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6-Minute Walk Test (6MWT) and Modified Borg Scale
Tidsramme: Baseline and 8 Weeks
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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
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Emrah Afsar, Phd, Kutahya Health Science University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 3D Insole in Pes Planus
- TDK-2026-365 (Annet stipend/finansieringsnummer: Kutahya Health Sciences University Scientific Research Projects Unit)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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