Back to resultsEffect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet
Primary Purpose
Flexible Flatfoot
Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Inverted foot orthoses
Sponsored by
About this trial
This is an interventional treatment trial for Flexible Flatfoot
Eligibility Criteria
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 (>5mm)
- BMI >30
- Pregnancy
Sites / Locations
- University of Sharjah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
25° inverted angle foot orthoses
15° inverted angle foot orthoses
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05316051
Brief Title
Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet
Official Title
Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nour Mustafaalsaafin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexible Flatfoot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25° inverted angle foot orthoses
Arm Type
Experimental
Arm Title
15° inverted angle foot orthoses
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Inverted foot orthoses
Intervention Description
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 Outcome Measure Information:
Title
Lower limb kinematics
Description
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.
Time Frame
Through study completion, an average of 1 year.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma A. Hegazy, PhD
Organizational Affiliation
University of Sharjah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sharjah
City
Sharjah
Country
United Arab Emirates
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet
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