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

Q

Quinnipiac University

Status

Completed

Conditions

Lower Extremity Pain of a Mechanical Origin

Treatments

Device: Full Contact Orthosis
Device: Maximal Arch Subtalar Stabilization

Study type

Interventional

Funder types

Other

Identifiers

NCT02143947
HEC 1404

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Full Contact Orthosis
Experimental group
Description:
Full Contact Orthosis
Treatment:
Device: Full Contact Orthosis
Maximal Arch Subtalar Stabilization
Experimental group
Description:
Maximal Arch Subtalar Stabilization Orthoses
Treatment:
Device: Maximal Arch Subtalar Stabilization

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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