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

NCT02143947 | Completed Results

• 1 other identifier: HEC 1404
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Pain of a Mechanical Origin

Keywords

Orthoses; Foot; Kinematics; EMG; Biomechanics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum Electromyographic Activity of Lower Leg Muscles

  Absolute values measured at 5 weeks

• Maximum Forefoot Inversion During Stance

  Absolute values measured at 5 weeks

• Maximum First Ray Complex Plantarflexion During Stance

  Absolute values measured at 5 weeks

Study Arms (2)

Full Contact Orthosis

EXPERIMENTAL

Full Contact Orthosis

Device: Full Contact Orthosis

Maximal Arch Subtalar Stabilization

EXPERIMENTAL

Maximal Arch Subtalar Stabilization Orthoses

Device: Maximal Arch Subtalar Stabilization

Interventions

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

Maximal Arch Subtalar Stabilization

Full Contact Orthosis DEVICE

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

Full Contact Orthosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quinnipiac University: lead
• Sole Supports, Inc: collaborator

Study Sites (1)

Motion Analysis Laboratory, Quinnipiac Unviersity

Hamden, Connecticut, 06518, United States

Location

Related Publications (1)

• 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.

  PMID: 26362236 DERIVED

Results Point of Contact

• Title: Juan C Garbalosa, PT, PhD, Director Motion Analysis Laboratory
• Organization: Quinnipiac University

juan.garbalosa@quinnipiac.edu

203 582 8552

Study Officials

• Juan C Garbalosa, PT, PhD

  Quinnipiac University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory, Clinical Associate Proffessor of Physical Therapy

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: September 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2010
• Last Updated: May 18, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)