Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04453787 |
Other study ID # |
YM108087F |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 5, 2020 |
Est. completion date |
September 30, 2022 |
Study information
Verified date |
October 2022 |
Source |
National Yang Ming University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.