Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet

NCT05316051 | Completed

• 1 other identifier: u20105881
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Inverted orthosis is a type of rigid foot orthosis that was designed to aid in controlling high degrees of foot pronation. It is essential to administer patients foot orthoses with different inverted angles, with higher angles prescribed when greater reduction of foot pronation is indicated. However, there is shortage of clinical knowledge regarding the inverted angle in terms of biomechanical changes. The aim of this study is to investigate the effect of different inverted angles of foot orthoses on the walking kinematics in females with flexible flatfeet.

Conditions

Flexible Flatfoot

Outcome Measures

Primary Outcomes (1)

• Lower limb kinematics

  Lower limb kinematics will be processed and calculated using a motion capture system (SMART-DX, BTS Bioengineering, Milan, Italy). The following kinematic variables will be obtained for each subject : (i) maximum hip extension angle, (ii) maximum hip adduction angle, (iii) maximum hip external rotation angle, (iv) maximum knee flexion angle during loading response, (v) maximum knee extension angle during midstance, (vi) maximum knee flexion angle at toe off, (vii) minimum knee abduction angle, (viii) maximum knee abduction angle, (ix) maximum knee external rotation angle, (x) maximum knee internal rotation angle, (xi) maximum ankle plantarflexion angle during loading response, (xii) maximum ankle dorsiflexion angle during midstance, (xiii) maximum ankle plantarflexion angle at toe off, (xiv) maximum ankle external rotation angle, (xv) maximum ankle internal rotation angle.

  Through study completion, an average of 1 year.

Study Arms (3)

25° inverted angle foot orthoses

EXPERIMENTAL

Device: Inverted foot orthoses

15° inverted angle foot orthoses

EXPERIMENTAL

Device: Inverted foot orthoses

Control

NO INTERVENTION

Interventions

Inverted foot orthoses DEVICE

Inverted functional orthoses will be used in this study based on Blake (1986) inverted orthotic technique. Two groups of foot orthosis will be fabricated with two different inverted angles: 25° inverted angle and 15° inverted angle.

15° inverted angle foot orthoses; 25° inverted angle foot orthoses

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females
• Within the age group of 18-35 years
• Asymptomatic flexible flatfeet
• Resting Calcaneal Stance Position angle of ≥ 4° in valgus in both feet (bilateral)

You may not qualify if:

• Previous surgery of the lower limbs or spine that might affect the performance of the study procedures
• Any severe medical or musculoskeletal conditions that may have affected the lower limbs
• Fixed flatfoot deformity
• Leg length discrepancy (\> 1cm)
• Pregnancy

Sponsors & Collaborators

• Nour Mustafaalsaafin: lead

Study Sites (1)

University of Sharjah

Sharjah city, United Arab Emirates

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Fatma A. Hegazy, PhD

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate Student

Study Record Dates

• First Submitted: March 19, 2022
• First Posted: April 7, 2022
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)