- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05316051
Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet
April 13, 2023 updated by: Nour Mustafaalsaafin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nour Mustafaalsaafin
- Phone Number: +971509669175
- Email: nalsaafina@sharjah.ac.ae
Study Locations
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-
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Sharjah, United Arab Emirates
- University of Sharjah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
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Experimental: 25° inverted angle foot orthoses
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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.
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Experimental: 15° inverted angle foot orthoses
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Through study completion, an average of 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatma A. Hegazy, PhD, University of Sharjah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Actual)
April 1, 2023
Study Completion (Actual)
April 1, 2023
Study Registration Dates
First Submitted
March 19, 2022
First Submitted That Met QC Criteria
March 29, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- u20105881
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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