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

Primary Purpose

Forefoot Varus, Flat Feet

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Arch support orthoses with forefoot medial wedge
Arch support orthoses
Flat insole
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forefoot Varus focused on measuring Forefoot varus, Forefoot medial wedge, Flat foot, Orthoses

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Yang Ming University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Arch support orthoses with forefoot medial wedge

Arch support orthoses

Flat insole

Arm Description

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

The intervention of this group include orthoses with arch support.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)
To determine the displacement of Cof during ambulation. We use F-Scan In-Shoe system to determine dynamic pressure, force and timing information. And to calculate the displacement of center of force of each gait cycle.
Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis
Muscle activity during ambulation and single leg standing. We use electromyography to record muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis.

Full Information

First Posted
June 22, 2020
Last Updated
October 3, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04453787
Brief Title
The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus
Official Title
The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
effected by the epidemic of COVID-19
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forefoot Varus, Flat Feet
Keywords
Forefoot varus, Forefoot medial wedge, Flat foot, Orthoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arch support orthoses with forefoot medial wedge
Arm Type
Experimental
Arm Description
The intervention of this group include orthoses with arch support and added forefoot medial wedge.
Arm Title
Arch support orthoses
Arm Type
Experimental
Arm Description
The intervention of this group include orthoses with arch support.
Arm Title
Flat insole
Arm Type
Sham Comparator
Arm Description
This group will wear a flat insole. It is made from ethylene-vinyl acetate copolymer with 4mm thickness. It only provide shock absorbtion.
Intervention Type
Other
Intervention Name(s)
Arch support orthoses with forefoot medial wedge
Other Intervention Name(s)
Forefoot medial wedge
Intervention Description
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
Intervention Name(s)
Arch support orthoses
Intervention Description
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
Intervention Name(s)
Flat insole
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot function index
Description
This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
Time Frame
Baseline
Title
Foot function index
Description
This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
Time Frame
6-week intervention
Title
Pain visual analogue scale (VAS)
Description
The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
Time Frame
Baseline
Title
Pain visual analogue scale (VAS)
Description
The scale is from 0 to 10 points. Zero means no pain, and ten points means extremely painful over subject's foot or leg.
Time Frame
6-week intervention
Title
Change From Baseline in Global Rating of Change Scale (GROC)
Description
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.
Time Frame
change from baseline at 6 weeks later
Secondary Outcome Measure Information:
Title
Displacement of center of force of gait cycle (medial-lateral and anterior-posterior)
Description
To determine the displacement of Cof during ambulation. We use F-Scan In-Shoe system to determine dynamic pressure, force and timing information. And to calculate the displacement of center of force of each gait cycle.
Time Frame
Baseline and after 6-week intervention
Title
Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis
Description
Muscle activity during ambulation and single leg standing. We use electromyography to record muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis.
Time Frame
Baseline and after 6-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Fen Shih, PhD
Organizational Affiliation
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
Official's Role
Study Director
Facility Information:
Facility Name
National Yang Ming University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan

12. IPD Sharing Statement

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

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