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

NCT04453787 | Terminated

• 1 other identifier: YM108087F
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Forefoot Varus; Flat Feet

Keywords

Forefoot varus; Forefoot medial wedge; Flat foot; Orthoses

Outcome Measures

Primary Outcomes (5)

• Foot function index

  This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.

  Baseline

• Foot function index

  This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.

  6-week intervention

• Pain visual analogue scale (VAS)

  The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.

  Baseline

• Pain visual analogue scale (VAS)

  The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.

  6-week intervention

• Change From Baseline in Global Rating of Change Scale (GROC)

  To measure improvements in a patient's condition. The minimum value is -7 and it means a very great deal worse. The maximum values is +7 and it means a very great deal better.

  change from baseline at 6 weeks later

Secondary Outcomes (2)

• Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)

  Baseline and after 6-week intervention

• Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis

  Baseline and after 6-week intervention

Study Arms (3)

Arch support orthoses with forefoot medial wedge

EXPERIMENTAL

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

Other: Arch support orthoses with forefoot medial wedge

Arch support orthoses

EXPERIMENTAL

The intervention of this group include orthoses with arch support.

Other: Arch support orthoses

Flat insole

SHAM COMPARATOR

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

Other: Flat insole

Interventions

Arch support orthoses with forefoot medial wedge 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.

Also known as: Forefoot medial wedge

Arch support orthoses with forefoot medial wedge

Arch support orthoses 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.

Arch support orthoses

Flat insole 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.

Flat insole

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming University

Taipei, 11221, Taiwan

Location

MeSH Terms

Conditions

Metatarsus Varus; Flatfoot

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yi-Fen Shih, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 1, 2020
• Study Start: October 5, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

TW (1)