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

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.

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.

Study Overview

• Status: Completed
• Conditions: Lower Extremity Pain of a Mechanical Origin
• Intervention / Treatment: Device: Full Contact Orthosis; Device: Maximal Arch Subtalar Stabilization

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Motion Analysis Laboratory, Quinnipiac Unviersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full Contact Orthosis	Device: Full Contact Orthosis; The Full Contact orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene.
Experimental: Maximal Arch Subtalar Stabilization; Maximal Arch Subtalar Stabilization Orthoses	Device: Maximal Arch Subtalar Stabilization; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Quinnipiac University
• Collaborators: Sole Supports, Inc
• Investigators: Principal Investigator: Juan C Garbalosa, PT, PhD, Quinnipiac University

Publications and helpful links

General Publications

• Garbalosa JC, Elliott B, Feinn R, Wedge R. The effect of orthotics on intersegmental foot kinematics and the EMG activity of select lower leg muscles. Foot (Edinb). 2015 Dec;25(4):206-14. doi: 10.1016/j.foot.2015.07.005. Epub 2015 Jul 14.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Estimate): May 18, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: EMG; Biomechanics; Kinematics; Orthoses; Foot
• Other Study ID Numbers: HEC 1404