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

Not Applicable

Completed

Conditions: Lower Extremity Pain of a Mechanical Origin

Interventions: Device: Full Contact Orthosis
Device: Maximal Arch Subtalar Stabilization

Registration Number: NCT02143947

Lead Sponsor: Quinnipiac University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full Contact Orthosis	Full Contact Orthosis	Full Contact Orthosis
Maximal Arch Subtalar Stabilization	Maximal Arch Subtalar Stabilization	Maximal Arch Subtalar Stabilization Orthoses

Primary Outcome Measures

Name	Time	Method
Maximum Rearfoot Eversion Motion During Stance	Absolute values measured at 5 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Electromyographic Activity of Lower Leg Muscles	Absolute values measured at 5 weeks	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
Maximum Forefoot Inversion During Stance	Absolute values measured at 5 weeks	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.
Maximum First Ray Complex Plantarflexion During Stance	Absolute values measured at 5 weeks	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.