Custom Molded Foot Orthoses Effect on Foot Kinematics and Lower Extremity Electromyography During Walking and Running.

Study Overview
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Brief Summary
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The purpose of this study was to determine the effectiveness of two types of in-shoe custom made orthotics in altering the motion of the foot and muscle activity of select muscles of the lower leg in individuals experiencing lower extremity symptoms of a non traumatic origin. We hypothesized that orthotics would decrease the extent of motion of the during walking and running when compared to a barefoot condition. The investigators further hypothesized that orthotics would decrease the amount of muscle activity seen during walking and running when compared to barefoot walking.

Official Title
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The Effect of Two Different Custom Molded Foot Orthoses on Inter-segmental Foot Kinematics and the EMG Activity of Selected Lower Leg Muscles During Walking and Running.

Conditions
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Lower Extremity Pain of a Mechanical Origin

Intervention / Treatment
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* Device: Maximal Arch Subtalar Stabilization
* Device: Full Contact Orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have complaints of lower extremity or foot pain of a non-traumatic, mechanical origin. Subjects must have at least 60 degrees of frontal plane forefoot on rearfoot passive range of motion (as determined by a modified Gib test in the symptomatic lower extremity. Subjects must be able to walk independently on a treadmill at a speed of 4.8 kmh. Subjects must have been referred by a health care professional for an orthosis fitting. Exclusion Criteria: Subjects having less than 60 degrees of forefoot on rearfoot frontal plane passive range of motion. Subjects having a history of a fracture of the foot or ankle. Subjects having any previous illness, surgery or other characteristic (e.g., cardiovascular, musculoskeletal or neuromuscular problems) that would affect their lower extremity function or ability to walk independently. Subjects having knee, lower leg or foot pain of a non-mechanical nature.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full Contact Orthosis<br>Full Contact Orthosis | Device: Full Contact Orthosis<br>* The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene.<br>|
| Experimental: Maximal Arch Subtalar Stabilization<br>Maximal Arch Subtalar Stabilization Orthoses | Device: Maximal Arch Subtalar Stabilization<br>* Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Rearfoot Eversion Motion During Stance | The rearfoot eversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum rearfoot eversion during each subphase determined. | Absolute values measured at 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Electromyographic Activity of Lower Leg Muscles | The maximum electromyographic activity of the lower leg muscles is with respect to the barefoot condition. The electromyographic activity of the lower extremity muscles were recorded during the stance phase of walking while barefoot and while wearing their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization). All electromyographic measurements were taken at the 5 week time point. The peak electromyographic activity during the stance phase of barefoot walking was determined. The electromyographic activity during the orthotic condition was amplitude normalized to the barefoot condition by dividing the electromyographic activity of the orthotic condition by the peak barefoot electromyographic activity and multiplying by 100. The stance phase of walking was then divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the peak amplitude normalized electromyographic activity of each subphase det | Absolute values measured at 5 weeks | 
| Maximum Forefoot Inversion During Stance | The forefoot inversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum forefoot inversion during each subphase determined. | Absolute values measured at 5 weeks | 
| Maximum First Ray Complex Plantarflexion During Stance | The first ray complex plantarflexion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum first ray complex plantarflexion during each subphase determined. | Absolute values measured at 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthoses, Foot, Kinematics, EMG, Biomechanics