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

Not Applicable

Completed

• Conditions: Flexible Flatfoot
• Interventions: Device: foot insole; Other: short foot exercise

• Registration Number: NCT04480177
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

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.

Study Timeline

• Study Start: 2018-10-27
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insole group	foot insole	the control group receives insole only.
exercise group	short foot exercise	the experimental group receives exercise and insole.
exercise group	foot insole	the experimental group receives exercise and insole.

Primary Outcome Measures

Name	Time	Method
The EMED (force-area-pressure)	6 weeks	The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.

Secondary Outcome Measures

Name	Time	Method
Lower extremities functional scale, navicular drop test	6 weeks	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.

Trial Locations

Locations (1)

Imam Abdulrahman Bin Faisal University; 🇸🇦 Dammam, Eastren, Saudi Arabia