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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05316051
Other study ID # u20105881
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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