Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects

Study Overview
=================
Brief Summary
-----------------
Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat foot. Little is known about the effectiveness of their interaction on managing flatfoot. The study aims to evaluate the effect of insoles and short foot exercise on the height and area of the medial longitudinal arch of flexible flatfoot participants as well as the force and pressure.

Detailed Description
-----------------
Study design: A parallel, active-control study design was used to conduct a single-blinded randomized controlled trial. Method: The toe rising test, the too many toes sign, and the navicular drop test was used to select 30 participants with flexible flatfoot. Participants was randomly assigned either to an experimental group (n = 15) or a control group (n = 15). The experimental group received short foot exercises (SFE) and insoles, and the control group received only insoles. SFE was implemented 30 times for a duration of three minutes each day over the course of six weeks. The exercise progressed from sitting to standing and finally to one leg stance position within every two weeks. The participants wore shoes containing orthotic insoles for eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure distribution (force, area, and pressure) at baseline and at two-week intervals throughout the six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate restriction in participants' functional abilities, and the navicular drop test (NDT) was used to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline and at the sixth week. Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two groups across time and within-subject observations of the outcomes.

Official Title
-----------------
Effect of Intrinsic Foot Muscles Training and Foot Orthosis on the Medial Longitudinal Arch in Flexible Flatfoot Subjects

Conditions
-----------------
Flexible Flatfoot

Intervention / Treatment
-----------------
* Device: foot insole
* Other: short foot exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females and males aged between 18 and 36 Bilateral symptomatic flexible flatfoot, with symptoms including foot pain and lower limb fatigue Participants must show positive physical examination findings, including a positive result for the too many toes sign, the navicular drop test, and the foot toe raising test (Carr et al., 2016). A positive result for the too many toes sign occurs when more toes can be seen on the lateral side of each foot due to external rotation and abduction of the feet, and the positive result for the toe rising test is the reconstruction of the medial longitudinal arch secondary to the tightness of the plantar fascia (Carr et al., 2016). A positive result for the navicular drop test is an arch height more than or equal to 10 mm(Aenumulapalli et al., 2017) Exclusion Criteria: An anatomical discrepancy in leg length Pathologic or neurologic disorders of the feet A history of traumatic foot injury or surgery within the last six months History of wearing foot orthoses within the past two years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: insole group<br>the control group receives insole only. | Device: foot insole<br>* the subject was instructed to wear foot insole for 8 hours.<br>|
| Experimental: exercise group<br>the experimental group receives exercise and insole. | Device: foot insole<br>* the subject was instructed to wear foot insole for 8 hours.<br>Other: short foot exercise<br>* the subject was instructed to perform exercise once a day 30 repetitions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The EMED (force-area-pressure) | The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremities functional scale, navicular drop test | The Lower extremities functional scale was used to evaluate restriction in participants' functional abilities, The score ranges from 0 to 80, and if it is higher indicating less functional restrictions. The navicular drop test was used to assess the medial longitudinal arch (MLA) height, A positive result for the navicular drop test is an arch height more than or equal to 10 mm. Both variables were measured at baseline and at the sixth week. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flatfoot, Insole, Short-foot exercise, Orthotic