Skip to content

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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02143947
Acronym
SOLE
Enrollment
80
Registered
2014-05-21
Start date
2008-09-30
Completion date
2010-04-30
Last updated
2015-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Extremity Pain of a Mechanical Origin

Keywords

Orthoses, Foot, Kinematics, EMG, Biomechanics

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.

Interventions

DEVICEMaximal Arch Subtalar Stabilization

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

DEVICEFull Contact Orthosis

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

Sponsors

Sole Supports, Inc
CollaboratorUNKNOWN
Quinnipiac University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum Rearfoot Eversion Motion During StanceAbsolute values measured at 5 weeksThe 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

MeasureTime frameDescription
Maximum Electromyographic Activity of Lower Leg MusclesAbsolute values measured at 5 weeksThe 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
Maximum Forefoot Inversion During StanceAbsolute values measured at 5 weeksThe 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.
Maximum First Ray Complex Plantarflexion During StanceAbsolute values measured at 5 weeksThe 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.

Countries

United States

Participant flow

Recruitment details

A convenience sample of subjects was obtained via email and bulletin board postings at a local private university. Recruitment commenced 9/1/08 and ended on 2/1/09.

Pre-assignment details

There were no significant events associated with this study.

Participants by arm

ArmCount
Full Contact Orthosis
Full Contact Orthosis Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene.
36
Maximal Arch Subtalar Stabilization
Maximal Arch Subtalar Stabilization Orthoses Maximal Arch Subtalar Stabilization: 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
44
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up42

Baseline characteristics

CharacteristicFull Contact OrthosisTotalMaximal Arch Subtalar Stabilization
Age, Categorical
<=18 years
7 Participants11 Participants4 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
29 Participants69 Participants40 Participants
Age, Continuous21.7 Years
STANDARD_DEVIATION 6.6
20.9 Years
STANDARD_DEVIATION 4.6
20.3 Years
STANDARD_DEVIATION 1.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
36 Participants80 Participants44 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
36 participants80 participants44 participants
Sex: Female, Male
Female
25 Participants57 Participants32 Participants
Sex: Female, Male
Male
11 Participants23 Participants12 Participants
Visual Analogue Pain Scale7.2 units on a scale
STANDARD_DEVIATION 1.7
7.0 units on a scale
STANDARD_DEVIATION 1.8
7.0 units on a scale
STANDARD_DEVIATION 2

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 360 / 44
serious
Total, serious adverse events
0 / 360 / 44

Outcome results

Primary

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.

Time frame: Absolute values measured at 5 weeks

Population: The number of participants used for the analysis was based upon the availability of complete data sets.

ArmMeasureGroupValue (MEAN)Dispersion
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 32.2 DegreesStandard Deviation 9.2
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 31.3 DegreesStandard Deviation 9.2
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 4-2.4 DegreesStandard Deviation 7.5
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 11.1 DegreesStandard Deviation 9.9
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 10.2 DegreesStandard Deviation 9.9
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 22.9 DegreesStandard Deviation 10
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 21.3 DegreesStandard Deviation 9.6
Full Contact OrthosisMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 4-2.7 DegreesStandard Deviation 8.1
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 23.1 DegreesStandard Deviation 10.5
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 32.7 DegreesStandard Deviation 9.9
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 4-0.9 DegreesStandard Deviation 9.2
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 23.0 DegreesStandard Deviation 10.3
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 32.7 DegreesStandard Deviation 9.2
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 4-1.1 DegreesStandard Deviation 8.8
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal-Orthotic Only, Phase 11.7 DegreesStandard Deviation 11.5
Maximal Arch Subtalar StabilizationMaximum Rearfoot Eversion Motion During StanceSandal Only, Phase 11.1 DegreesStandard Deviation 11.3
p-value: >0.1Mixed Models Analysis
Secondary

Maximum Electromyographic Activity of Lower Leg Muscles

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

Time frame: Absolute values measured at 5 weeks

Population: The number of participants used for the analysis was based upon the availability of complete data sets.

ArmMeasureGroupValue (MEAN)Dispersion
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 418.8 percentage of maximum electromyo actvityStandard Deviation 18.6
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 235.1 percentage of maximum electromyo actvityStandard Deviation 26.6
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibialis Anterior Phase 169.5 percentage of maximum electromyo actvityStandard Deviation 24.8
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 349.4 percentage of maximum electromyo actvityStandard Deviation 48.6
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibailis Anterior Phase 223.6 percentage of maximum electromyo actvityStandard Deviation 14.1
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 427.4 percentage of maximum electromyo actvityStandard Deviation 48.7
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 141.5 percentage of maximum electromyo actvityStandard Deviation 29.2
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibialis Anterior Phase 329.6 percentage of maximum electromyo actvityStandard Deviation 14.9
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 248.1 percentage of maximum electromyo actvityStandard Deviation 33.5
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 352.5 percentage of maximum electromyo actvityStandard Deviation 35.1
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 145.5 percentage of maximum electromyo actvityStandard Deviation 32.8
Full Contact OrthosisMaximum Electromyographic Activity of Lower Leg MusclesTibialis Anterior Phase 441.9 percentage of maximum electromyo actvityStandard Deviation 14.4
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 425.8 percentage of maximum electromyo actvityStandard Deviation 28.6
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 150.2 percentage of maximum electromyo actvityStandard Deviation 29.7
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 258.7 percentage of maximum electromyo actvityStandard Deviation 37.5
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibailis Anterior Phase 227.1 percentage of maximum electromyo actvityStandard Deviation 23.6
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibialis Anterior Phase 330.9 percentage of maximum electromyo actvityStandard Deviation 19.7
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibialis Anterior Phase 446.8 percentage of maximum electromyo actvityStandard Deviation 16.7
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 246.0 percentage of maximum electromyo actvityStandard Deviation 28.4
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 353.1 percentage of maximum electromyo actvityStandard Deviation 35.2
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibialis Posterior Phase 420.9 percentage of maximum electromyo actvityStandard Deviation 19.6
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 140.8 percentage of maximum electromyo actvityStandard Deviation 24.4
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesPeroneus Longus Phase 355.7 percentage of maximum electromyo actvityStandard Deviation 36.9
Maximal Arch Subtalar StabilizationMaximum Electromyographic Activity of Lower Leg MusclesTibialis Anterior Phase 171.2 percentage of maximum electromyo actvityStandard Deviation 21.9
p-value: =0.036Mixed Models Analysis
Secondary

Maximum First Ray Complex Plantarflexion During Stance

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.

Time frame: Absolute values measured at 5 weeks

Population: The number of participants used for the analysis was based upon the availability of complete data sets.

ArmMeasureGroupValue (MEAN)Dispersion
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 1-6.96 DegreesStandard Deviation 3.8
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 3-1.25 DegreesStandard Deviation 2.9
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 2-2.92 DegreesStandard Deviation 3.3
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 2-3.37 DegreesStandard Deviation 3.3
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 4-4.07 DegreesStandard Deviation 4.4
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 1-6.49 DegreesStandard Deviation 3.8
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 3-1.03 DegreesStandard Deviation 2.9
Full Contact OrthosisMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 4-4.07 DegreesStandard Deviation 4.4
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 4-3.24 DegreesStandard Deviation 5.4
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 2-1.22 DegreesStandard Deviation 4.8
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 4-4.39 DegreesStandard Deviation 6
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 3.62 DegreesStandard Deviation 4.4
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 2-1.5 DegreesStandard Deviation 4.2
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 1-4.95 DegreesStandard Deviation 5
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal-Orthotic, Phase 1-4.67 DegreesStandard Deviation 4.4
Maximal Arch Subtalar StabilizationMaximum First Ray Complex Plantarflexion During StanceSandal Only, Phase 31.54 DegreesStandard Deviation 5.3
p-value: <0.05Mixed Models Analysis
Secondary

Maximum Forefoot Inversion During Stance

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.

Time frame: Absolute values measured at 5 weeks

Population: The number of participants used for the analysis was based upon the availability of complete data sets.

ArmMeasureGroupValue (MEAN)Dispersion
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 2-11.4 DegreesStandard Deviation 10.8
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 3-12.6 DegreesStandard Deviation 9.8
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal Only, Phase 1-13.0 DegreesStandard Deviation 9.7
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal Only, Phase 2-12.2 DegreesStandard Deviation 10.2
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal Only, Phase 3-12.7 DegreesStandard Deviation 8.9
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal Only, Phase 4-12.7 DegreesStandard Deviation 8.5
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 1-12.0 DegreesStandard Deviation 10.5
Full Contact OrthosisMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 4-11.9 DegreesStandard Deviation 9.3
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal Only, Phase 2-12.9 DegreesStandard Deviation 11.8
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 2-13.6 DegreesStandard Deviation 11.7
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal Only, Phase 4-14.7 DegreesStandard Deviation 10.9
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 3-14.0 DegreesStandard Deviation 10.7
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 4-14.6 DegreesStandard Deviation 11
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal Only, Phase 3-14.0 DegreesStandard Deviation 10.2
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal Only, Phase 1-13.8 DegreesStandard Deviation 12.2
Maximal Arch Subtalar StabilizationMaximum Forefoot Inversion During StanceSandal-Orthotic Only, Phase 1-14.2 DegreesStandard Deviation 12
p-value: >0.1Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026