N/A
N=80
Custom Molded Foot Orthoses Effect on Foot Kinematics and Lower Extremity Electromyography During Walking and Running.
Lower Extremity Pain of a Mechanical Origin
Bottom Line
View on ClinicalTrials.gov: NCT02143947 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Maximum Rearfoot Eversion Motion During Stance — 1.1; 1.1; 2.9; 3.0 Degrees — p=> .10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Maximal Arch Subtalar Stabilization (Device); Full Contact Orthosis (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Quinnipiac University
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Rearfoot Eversion Motion During Stance |
1.1; 1.1; 2.9; 3.0; 2.2; 2.7 | > .10 |
| SECONDARY Maximum Electromyographic Activity of Lower Leg Muscles |
69.5; 71.2; 23.6; 27.1; 29.6; 30.9 | = .036 sig |
| SECONDARY Maximum Forefoot Inversion During Stance |
-13.0; -13.8; -12.2; -12.9; -12.7; -14.0 | > .10 |
| SECONDARY Maximum First Ray Complex Plantarflexion During Stance |
-6.96; -4.95; -3.37; -1.22; -1.25; 1.54 | < .05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02143947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.