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| Name | Class |
|---|---|
| Sole Supports, Inc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Contact Orthosis | Experimental | Full Contact Orthosis |
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| Maximal Arch Subtalar Stabilization | Experimental | Maximal Arch Subtalar Stabilization Orthoses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan C Garbalosa, PT, PhD | Quinnipiac University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motion Analysis Laboratory, Quinnipiac Unviersity | Hamden | Connecticut | 06518 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26362236 | Derived | 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. |
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There were no significant events associated with this study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Contact Orthosis | Full Contact Orthosis Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene. |
| FG001 | Maximal Arch Subtalar Stabilization |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Full Contact Orthosis | Device | The Full Contact orthosis is constructed from a 5/32" blue polypropylene with posting material comprised of white polypropylene. |
|
| 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. | 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. | Absolute values measured at 5 weeks |
Maximal Arch Subtalar Stabilization Orthoses Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a 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 |
| COMPLETED |
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| NOT COMPLETED |
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The number participants for analysis was based upon the number of participants who attended the first data collection.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Visual Analogue Pain Scale | The visual analogue scale has a range from 0 to 10. 0 representing no pain, 10 representing the worse possible pain. Higher scores are considered worse. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants used for the analysis was based upon the availability of complete data sets. | Posted | Mean | Standard Deviation | Degrees | Absolute values measured at 5 weeks |
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| 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 | The number of participants used for the analysis was based upon the availability of complete data sets. | Posted | Mean | Standard Deviation | percentage of maximum electromyo actvity | Absolute values measured at 5 weeks |
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| 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. | The number of participants used for the analysis was based upon the availability of complete data sets. | Posted | Mean | Standard Deviation | Degrees | Absolute values measured at 5 weeks |
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| 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. | The number of participants used for the analysis was based upon the availability of complete data sets. | Posted | Mean | Standard Deviation | Degrees | Absolute values measured at 5 weeks |
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Adverse event data was collected for one year
Adverse event information was collected at the time of the 5 week data collection via direct observation and a 3 and 6 month and 1 year follow up via telephone or email interview.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 36 | 0 | 36 | ||
| EG001 | 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 | 0 | 44 | 0 | 44 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan C Garbalosa, PT, PhD, Director Motion Analysis Laboratory | Quinnipiac University | 203 582 8552 | juan.garbalosa@quinnipiac.edu |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Sandal Only, Phase 3 |
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| Sandal Only, Phase 4 |
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| Sandal-Orthotic Only, Phase 1 |
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| Sandal-Orthotic Only, Phase 2 |
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| Sandal-Orthotic Only, Phase 3 |
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| Sandal-Orthotic Only, Phase 4 |
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Maximal Arch Subtalar Stabilization Orthoses Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a 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 |
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