The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus

NCT ID: NCT04453787

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2022-09-30

Brief Summary

Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.

One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.

Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.

However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.

Detailed Description

Forefoot varus is a type of foot deformities. It is asociate with subtalar joint hyperpronation, and cause too much stress over tissues around foot and lower leg during weight bearing activities.

One of the common interventions for forefoot varus is to use foot orthosis with medial forefoot wedge to accommodate the forefoot deformity. Forefoot varus has been considered as an osseus deformity and caused by insufficient talar torsion during development. However, recent studies have reported forefoot varus may not be an osseus deformity. They might be a result of soft tissue adaption. For example, subtalar joint hyperpronation and ankle equinus could lead to forefoot supination/compensatory forefoot varus, which could be mistaken for osseus forefoot varus after a long period of time. If compensatory forefoot varus is caused by soft tissue adaptions, these adaptions may have a chance to reverse.

Nowadays, orthoses which applying medial forefoot wedge to accommodate the deformity for forefoot varus deformity, and the other type orthoses which applying rearfoot medial wedge and arch support are both used in subject with forefoot varus deformity.

However, some colleges claims that using medial forefoot wedge to accommodate the deformity of forefoot varus, the deformity may be fixed after a long-term period. However, there were no studies compare the effect of arch support orthosis that with and without medial forefoot wedge.

In consideration of few studies have been done for investigating the effects of different orthoses in subjects with flat foot combined forefoot varus. Thus, the purpose of this study is to investigate the effect of different foot orthoses designs on improving pain, muscle activity and displacement of center of pressure. We hypothesized that both orthoses will have the better effect on improving pain than placebo orthoses ,and muscle activity and displacement of center of pressure of arch support orthoses group will have change which close to normal foot.

Conditions

Forefoot Varus; Flat Feet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arch support orthoses with forefoot medial wedge

The intervention of this group include orthoses with arch support and added forefoot medial wedge.

Group Type: EXPERIMENTAL

Arch support orthoses with forefoot medial wedge

Intervention Type: OTHER

The degree of forefoot wedge will be 3 degree. If needed, it could be adjusted. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.

Arch support orthoses

The intervention of this group include orthoses with arch support.

Group Type: EXPERIMENTAL

Arch support orthoses

Intervention Type: OTHER

The arch support of the orthoses could be adjusted depends on the evaluation of subject. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.

Flat insole

This group will wear a flat insole. It is made from ethylene-vinyl acetate copolymer with 4mm thickness. It only provide shock absorbtion.

Group Type: SHAM_COMPARATOR

Flat insole

Intervention Type: OTHER

The flat insole used as a placebo intervention. The shape of this insole is flat, and made by soft EVA. It only provide shock absorbtion without any support. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.

Interventions

Arch support orthoses with forefoot medial wedge

The degree of forefoot wedge will be 3 degree. If needed, it could be adjusted. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.

Intervention Type: OTHER

Arch support orthoses

The arch support of the orthoses could be adjusted depends on the evaluation of subject. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.

Intervention Type: OTHER

Flat insole

The flat insole used as a placebo intervention. The shape of this insole is flat, and made by soft EVA. It only provide shock absorbtion without any support. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.

Intervention Type: OTHER

Other Intervention Names

Forefoot medial wedge

Eligibility Criteria

Inclusion Criteria

• Flexible flatfoot
• Angle of forefoot varus > 6 degree
• Feel leg or foot pain when walking or exercising, and pain visual analogue scale > 3 points
• The duration of wearing shoes > 30 he per week

Exclusion Criteria

• Rigid flatfoot
• Leg length discrepancy > 1cm
• Angle of Hallux valgus > 20 degree
• With any nerve problem or disease
• Used to have trauma over lower limbs
• Had any severe joint deformity or osteoarthritis over lower limbs
• Had any acute injury (in two weeks and inflammation)
• Had wearing insole for 6 months
• Can't follow order

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Yi-Fen Shih

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi-Fen Shih, PhD

Role: STUDY_DIRECTOR

Department of Physical Therapy and Assistive Technology, National Yang-Ming University

Locations

National Yang Ming University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

YM108087F

Identifier Type: -

Identifier Source: org_study_id