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

Flexible Flatfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316051
• Other study ID #: u20105881
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: University of Sharjah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Flatfoot
• Flexible Flatfoot

Intervention

Device:
• Inverted foot orthoses
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.

Locations

Country	Name	City	State
United Arab Emirates	University of Sharjah	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
Nour Mustafaalsaafin

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.