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

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ClinicalTrials.gov Identifier: NCT04453787
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Yi-Fen Shih, National Yang Ming University

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE July 1, 2020
Last Update Posted Date July 1, 2020
Estimated Study Start Date  ICMJE July 15, 2020
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2020)
  • Foot function index [ Time Frame: Baseline ]
    This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
  • Foot function index [ Time Frame: 6-week intervention ]
    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) [ Time Frame: Baseline ]
    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) [ Time Frame: 6-week intervention ]
    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) [ Time Frame: change from baseline at 6 weeks later ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2020)
  • Displacement of center of force of gait cycle (medial-lateral and anterior-posterior) [ Time Frame: Baseline and after 6-week intervention ]
    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 [ Time Frame: Baseline and after 6-week intervention ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus
Official Title  ICMJE The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Forefoot Varus
  • Flat Feet
Intervention  ICMJE
  • Other: 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.
    Other Name: Forefoot medial wedge
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Arch support orthoses with forefoot medial wedge
    The intervention of this group include orthoses with arch support and added forefoot medial wedge.
    Intervention: Other: Arch support orthoses with forefoot medial wedge
  • Experimental: Arch support orthoses
    The intervention of this group include orthoses with arch support.
    Intervention: Other: Arch support orthoses
  • Sham Comparator: 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.
    Intervention: Other: Flat insole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yi-Fen Shih, PhD +886-2-28267340 yfshih@ym.edu.tw
Contact: Wen-Yu Shih, BS +886926827661 ioe258guy@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04453787
Other Study ID Numbers  ICMJE YM108087F
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi-Fen Shih, National Yang Ming University
Study Sponsor  ICMJE National Yang Ming University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yi-Fen Shih, PhD Department of Physical Therapy and Assistive Technology, National Yang-Ming University
PRS Account National Yang Ming University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP