Skip to main content
OpenTrials
Completed

NCT Number: NCT02143947

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Extremity Pain of a Mechanical Origin

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Motion Analysis Laboratory, Quinnipiac Unviersity

Hamden, Connecticut, 06518, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maximal Arch Subtalar Stabilization

Device

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

Full Contact Orthosis

Device

The Full Contact orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene.

Primary outcomes

  1. Maximum Rearfoot Eversion Motion During Stance

    Time frame: 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 outcomes

  1. Maximum Electromyographic Activity of Lower Leg Muscles

    Time frame: 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

  2. Maximum Forefoot Inversion During Stance

    Time frame: 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.

  3. Maximum First Ray Complex Plantarflexion During Stance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Quinnipiac University

Other

Collaborators

  • Sole Supports, Inc

Registry information

Official study 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.

Acronym: SOLE

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 21, 2014
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.