Skip to main content
OpenTrials
Completed

NCT Number: NCT04480177

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imam Abdulrahman Bin Faisal University

Dammam, Eastren, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

foot insole

Device

the subject was instructed to wear foot insole for 8 hours.

short foot exercise

Other

the subject was instructed to perform exercise once a day 30 repetitions.

Primary outcomes

  1. The EMED (force-area-pressure)

    Time frame: 6 weeks

    The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.

Secondary outcomes

  1. Lower extremities functional scale, navicular drop test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.