Trial Outcomes & Findings for Custom Molded Foot Orthoses Effect on Foot Kinematics and Lower Extremity Electromyography During Walking and Running. (NCT NCT02143947)
NCT ID: NCT02143947
Last Updated: 2015-05-18
Results Overview
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.
COMPLETED
NA
80 participants
Absolute values measured at 5 weeks
2015-05-18
Participant Flow
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.
There were no significant events associated with this study.
Participant milestones
| Measure |
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.
|
Maximal Arch Subtalar Stabilization
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
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
44
|
|
Overall Study
COMPLETED
|
32
|
42
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Maximal Arch Subtalar Stabilization
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Custom Molded Foot Orthoses Effect on Foot Kinematics and Lower Extremity Electromyography During Walking and Running.
Baseline characteristics by cohort
| Measure |
Full Contact Orthosis
n=36 Participants
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.
|
Maximal Arch Subtalar Stabilization
n=44 Participants
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
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.7 Years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
20.3 Years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
20.9 Years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
44 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Visual Analogue Pain Scale
|
7.2 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Absolute values measured at 5 weeksPopulation: The number of participants used for the analysis was based upon the availability of complete data sets.
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.
Outcome measures
| Measure |
Full Contact Orthosis
n=26 Participants
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.
|
Maximal Arch Subtalar Stabilization
n=26 Participants
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
|
|---|---|---|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal-Orthotic Only, Phase 1
|
0.2 Degrees
Standard Deviation 9.9
|
1.7 Degrees
Standard Deviation 11.5
|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal Only, Phase 1
|
1.1 Degrees
Standard Deviation 9.9
|
1.1 Degrees
Standard Deviation 11.3
|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal Only, Phase 2
|
2.9 Degrees
Standard Deviation 10.0
|
3.0 Degrees
Standard Deviation 10.3
|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal Only, Phase 3
|
2.2 Degrees
Standard Deviation 9.2
|
2.7 Degrees
Standard Deviation 9.2
|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal Only, Phase 4
|
-2.4 Degrees
Standard Deviation 7.5
|
-1.1 Degrees
Standard Deviation 8.8
|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal-Orthotic Only, Phase 2
|
1.3 Degrees
Standard Deviation 9.6
|
3.1 Degrees
Standard Deviation 10.5
|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal-Orthotic Only, Phase 3
|
1.3 Degrees
Standard Deviation 9.2
|
2.7 Degrees
Standard Deviation 9.9
|
|
Maximum Rearfoot Eversion Motion During Stance
Sandal-Orthotic Only, Phase 4
|
-2.7 Degrees
Standard Deviation 8.1
|
-0.9 Degrees
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Absolute values measured at 5 weeksPopulation: The number of participants used for the analysis was based upon the availability of complete data sets.
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
Outcome measures
| Measure |
Full Contact Orthosis
n=26 Participants
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.
|
Maximal Arch Subtalar Stabilization
n=26 Participants
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
|
|---|---|---|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibialis Posterior Phase 1
|
45.5 percentage of maximum electromyo actvity
Standard Deviation 32.8
|
50.2 percentage of maximum electromyo actvity
Standard Deviation 29.7
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibialis Posterior Phase 3
|
49.4 percentage of maximum electromyo actvity
Standard Deviation 48.6
|
53.1 percentage of maximum electromyo actvity
Standard Deviation 35.2
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibialis Posterior Phase 4
|
27.4 percentage of maximum electromyo actvity
Standard Deviation 48.7
|
20.9 percentage of maximum electromyo actvity
Standard Deviation 19.6
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibialis Anterior Phase 1
|
69.5 percentage of maximum electromyo actvity
Standard Deviation 24.8
|
71.2 percentage of maximum electromyo actvity
Standard Deviation 21.9
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibailis Anterior Phase 2
|
23.6 percentage of maximum electromyo actvity
Standard Deviation 14.1
|
27.1 percentage of maximum electromyo actvity
Standard Deviation 23.6
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibialis Anterior Phase 3
|
29.6 percentage of maximum electromyo actvity
Standard Deviation 14.9
|
30.9 percentage of maximum electromyo actvity
Standard Deviation 19.7
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibialis Anterior Phase 4
|
41.9 percentage of maximum electromyo actvity
Standard Deviation 14.4
|
46.8 percentage of maximum electromyo actvity
Standard Deviation 16.7
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Tibialis Posterior Phase 2
|
35.1 percentage of maximum electromyo actvity
Standard Deviation 26.6
|
46.0 percentage of maximum electromyo actvity
Standard Deviation 28.4
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Peroneus Longus Phase 1
|
41.5 percentage of maximum electromyo actvity
Standard Deviation 29.2
|
40.8 percentage of maximum electromyo actvity
Standard Deviation 24.4
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Peroneus Longus Phase 2
|
48.1 percentage of maximum electromyo actvity
Standard Deviation 33.5
|
58.7 percentage of maximum electromyo actvity
Standard Deviation 37.5
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Peroneus Longus Phase 3
|
52.5 percentage of maximum electromyo actvity
Standard Deviation 35.1
|
55.7 percentage of maximum electromyo actvity
Standard Deviation 36.9
|
|
Maximum Electromyographic Activity of Lower Leg Muscles
Peroneus Longus Phase 4
|
18.8 percentage of maximum electromyo actvity
Standard Deviation 18.6
|
25.8 percentage of maximum electromyo actvity
Standard Deviation 28.6
|
SECONDARY outcome
Timeframe: Absolute values measured at 5 weeksPopulation: The number of participants used for the analysis was based upon the availability of complete data sets.
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.
Outcome measures
| Measure |
Full Contact Orthosis
n=26 Participants
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.
|
Maximal Arch Subtalar Stabilization
n=26 Participants
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
|
|---|---|---|
|
Maximum Forefoot Inversion During Stance
Sandal Only, Phase 1
|
-13.0 Degrees
Standard Deviation 9.7
|
-13.8 Degrees
Standard Deviation 12.2
|
|
Maximum Forefoot Inversion During Stance
Sandal Only, Phase 2
|
-12.2 Degrees
Standard Deviation 10.2
|
-12.9 Degrees
Standard Deviation 11.8
|
|
Maximum Forefoot Inversion During Stance
Sandal Only, Phase 3
|
-12.7 Degrees
Standard Deviation 8.9
|
-14.0 Degrees
Standard Deviation 10.2
|
|
Maximum Forefoot Inversion During Stance
Sandal Only, Phase 4
|
-12.7 Degrees
Standard Deviation 8.5
|
-14.7 Degrees
Standard Deviation 10.9
|
|
Maximum Forefoot Inversion During Stance
Sandal-Orthotic Only, Phase 1
|
-12.0 Degrees
Standard Deviation 10.5
|
-14.2 Degrees
Standard Deviation 12.0
|
|
Maximum Forefoot Inversion During Stance
Sandal-Orthotic Only, Phase 2
|
-11.4 Degrees
Standard Deviation 10.8
|
-13.6 Degrees
Standard Deviation 11.7
|
|
Maximum Forefoot Inversion During Stance
Sandal-Orthotic Only, Phase 3
|
-12.6 Degrees
Standard Deviation 9.8
|
-14.0 Degrees
Standard Deviation 10.7
|
|
Maximum Forefoot Inversion During Stance
Sandal-Orthotic Only, Phase 4
|
-11.9 Degrees
Standard Deviation 9.3
|
-14.6 Degrees
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Absolute values measured at 5 weeksPopulation: The number of participants used for the analysis was based upon the availability of complete data sets.
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.
Outcome measures
| Measure |
Full Contact Orthosis
n=26 Participants
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.
|
Maximal Arch Subtalar Stabilization
n=26 Participants
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
|
|---|---|---|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal Only, Phase 1
|
-6.96 Degrees
Standard Deviation 3.8
|
-4.95 Degrees
Standard Deviation 5.0
|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal Only, Phase 2
|
-3.37 Degrees
Standard Deviation 3.3
|
-1.22 Degrees
Standard Deviation 4.8
|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal Only, Phase 3
|
-1.25 Degrees
Standard Deviation 2.9
|
1.54 Degrees
Standard Deviation 5.3
|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal Only, Phase 4
|
-4.07 Degrees
Standard Deviation 4.4
|
-4.39 Degrees
Standard Deviation 6.0
|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal-Orthotic, Phase 1
|
-6.49 Degrees
Standard Deviation 3.8
|
-4.67 Degrees
Standard Deviation 4.4
|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal-Orthotic, Phase 2
|
-2.92 Degrees
Standard Deviation 3.3
|
-1.5 Degrees
Standard Deviation 4.2
|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal-Orthotic, Phase 3
|
-1.03 Degrees
Standard Deviation 2.9
|
.62 Degrees
Standard Deviation 4.4
|
|
Maximum First Ray Complex Plantarflexion During Stance
Sandal-Orthotic, Phase 4
|
-4.07 Degrees
Standard Deviation 4.4
|
-3.24 Degrees
Standard Deviation 5.4
|
Adverse Events
Full Contact Orthosis
Maximal Arch Subtalar Stabilization
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Juan C Garbalosa, PT, PhD, Director Motion Analysis Laboratory
Quinnipiac University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place