Clinical trial NCT02143947: Custom Molded Foot Orthoses Effect on Foot Kinematics and Lower Extremity Electromyography During Walking and Running.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Pain of a Mechanical Origin
Keywords: Orthoses
Foot
Kinematics
EMG
Biomechanics
Lead sponsor: Quinnipiac University
Sponsor class: OTHER
Collaborators: name: Sole Supports, Inc
First posted: 2014-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Rearfoot Eversion Motion During Stance
timeFrame: Absolute values measured at 5 weeks
Secondary outcomes:
measure: Maximum Electromyographic Activity of Lower Leg Muscles
timeFrame: Absolute values measured at 5 weeks
measure: Maximum Forefoot Inversion During Stance
timeFrame: Absolute values measured at 5 weeks
measure: Maximum First Ray Complex Plantarflexion During Stance
timeFrame: Absolute values measured at 5 weeks
Other outcomes:
Locations:
city: Hamden
country: United States
facility: Motion Analysis Laboratory, Quinnipiac Unviersity
state: Connecticut
Study officials:
affiliation: Quinnipiac University
name: Juan C Garbalosa, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.