NCT04480177

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Imam Abdulrahman Bin Faisal University · Academic / Other
• Sex: All
• Age: 18 Years – 36 Years
• Healthy volunteers: Accepted

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.

Conditions

• Flexible Flatfoot

Interventions

Type	Name	Description
DEVICE	foot insole	the subject was instructed to wear foot insole for 8 hours.
OTHER	short foot exercise	the subject was instructed to perform exercise once a day 30 repetitions.

Timeline

• Start date: 2018-10-27
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2020-07-21
• Last updated: 2020-07-21

Locations

1 site across 1 country: Saudi Arabia