Lower Extremity Pain of a Mechanical OriginSOLENCT02143947

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

A study testing Maximal Arch Subtalar Stabilization and Full Contact Orthosis in people with Lower Extremity Pain of a Mechanical Origin, run by Quinnipiac University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Lower Extremity Pain of a Mechanical Origin
What is being tested?: Maximal Arch Subtalar Stabilization and Full Contact Orthosis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Apr 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Motion Analysis Laboratory, Quinnipiac Unviersity
Hamden, Connecticut, 06518

Other trials in United States

About this study

Official 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.

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
Being tested: Maximal Arch Subtalar Stabilization, Full Contact Orthosis
Keywords: Orthoses, Foot, Kinematics, EMG, Biomechanics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02143947
Study group	Role	What they receive
Full Contact Orthosis	Experimental	Full Contact Orthosis Receives: Device: Full Contact Orthosis
Maximal Arch Subtalar Stabilization	Experimental	Maximal Arch Subtalar Stabilization Orthoses Receives: Device: Maximal Arch Subtalar Stabilization

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Absolute values measured at 5 weeks

Secondary outcomes (3)

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
Measured: Absolute values measured at 5 weeks
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.
Measured: Absolute values measured at 5 weeks
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.
Measured: Absolute values measured at 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Apr 2010

First posted21 May 2014 (estimated)
Study startSep 2008
Primary completionApr 2009
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lower Extremity Pain of a Mechanical OriginStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02143947
Sponsor's protocol ID: HEC 1404
Acronym: SOLE
Status last verified: Apr 2015
First submitted: 19 May 2014
Last updated: 18 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26362236

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT02143947
Acronym / sponsor ID: SOLE / HEC 1404
Conditions: Lower Extremity Pain of a Mechanical Origin
Keywords: Orthoses, Foot, Kinematics, EMG, Biomechanics
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Quinnipiac UniversityUniversity, hospital or other
Collaborators: Sole Supports, Inc
Study start: Sep 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 21 May 2014 (estimated)
Results: Posted 30 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Full Contact Orthosis	Experimental	Device: Full Contact OrthosisFull Contact Orthosis
Maximal Arch Subtalar Stabilization	Experimental	Device: Maximal Arch Subtalar StabilizationMaximal Arch Subtalar Stabilization Orthoses

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Maximal Arch Subtalar StabilizationCustom 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	Device	Maximal Arch Subtalar Stabilization
Full Contact OrthosisThe Full Contact orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene.	Device	Full Contact Orthosis

Primary outcome

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.

3 secondary outcomes

Maximum Electromyographic Activity of Lower Leg Muscles
Time frame: Absolute values measured at 5 weeks
Maximum Forefoot Inversion During Stance
Time frame: Absolute values measured at 5 weeks
Maximum First Ray Complex Plantarflexion During Stance
Time frame: Absolute values measured at 5 weeks

Results and safety

Results posted to the registry on 30 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full Contact Orthosis	36	32
Maximal Arch Subtalar Stabilization	44	42

Primary outcome: Maximum Rearfoot Eversion Motion During Stance

Time frame: Absolute values measured at 5 weeks. Mean (Standard Deviation). Unit: Degrees

Measure	Full Contact Orthosis n = 26	Maximal Arch Subtalar Stabilization n = 26
Sandal Only, Phase 1	1.1 (9.9)	1.1 (11.3)
Sandal Only, Phase 2	2.9 (10.0)	3.0 (10.3)
Sandal Only, Phase 3	2.2 (9.2)	2.7 (9.2)
Sandal Only, Phase 4	-2.4 (7.5)	-1.1 (8.8)
Sandal-Orthotic Only, Phase 1	0.2 (9.9)	1.7 (11.5)
Sandal-Orthotic Only, Phase 2	1.3 (9.6)	3.1 (10.5)
Sandal-Orthotic Only, Phase 3	1.3 (9.2)	2.7 (9.9)
Sandal-Orthotic Only, Phase 4	-2.7 (8.1)	-0.9 (9.2)

Full Contact Orthosis vs Maximal Arch Subtalar Stabilization: p > .10, Mixed Models Analysis

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for one year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full Contact Orthosis	0 of 36 (0%)	0 of 36 (0%)	Not reported
Maximal Arch Subtalar Stabilization	0 of 44 (0%)	0 of 44 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26362236Garbalosa 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juan C Garbalosa, PT, PhD principal investigator

Quinnipiac University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Maximal Arch Subtalar Stabilization and Full Contact Orthosis in people with Lower Extremity Pain of a Mechanical Origin, run by Quinnipiac University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Rearfoot Eversion Motion During Stance (time frame: Absolute values measured at 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02143947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.