The Effects of Different Types of Foot Orthosis in Adults With Compensatory Forefoot Varus
- Conditions
- Forefoot VarusFlat Feet
- Interventions
- Other: Arch support orthosesOther: Arch support orthoses with forefoot medial wedgeOther: Flat insole
- Registration Number
- NCT04453787
- Lead Sponsor
- National Yang Ming Chiao Tung University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arch support orthoses Arch support orthoses The intervention of this group include orthoses with arch support. Arch support orthoses with forefoot medial wedge Arch support orthoses with forefoot medial wedge The intervention of this group include orthoses with arch support and added forefoot medial wedge. Flat insole 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.
- Primary Outcome Measures
Name Time Method Foot function index 6-week intervention This questionnaire includes 23 questions. These questions are about how difficult or pain over foot when subjects doing some functional activities.
Change From Baseline in Global Rating of Change Scale (GROC) 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.
Pain visual analogue scale (VAS) 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.
- Secondary Outcome Measures
Name Time Method Muscle activity of tibialis anterior muscle, peroneal longus and abductor hallucis brevis 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.
Displacement of center of force of gait cycle (medial-lateral and anterior-posterior) 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.
Trial Locations
- Locations (1)
National Yang Ming University
🇨🇳Taipei, Taiwan