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Completed

NCT Number: NCT05316051

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

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Sharjah

Sharjah city, United Arab Emirates

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Lower limb kinematics

    Time frame: Through study completion, an average of 1 year.

    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.

Sponsors and collaborators

Lead sponsor

Nour Mustafaalsaafin

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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