Trial Outcomes & Findings for Iterative Design of Custom Dynamic Orthoses (NCT NCT04800510)
NCT ID: NCT04800510
Last Updated: 2026-01-30
Results Overview
Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure.
COMPLETED
NA
9 participants
Baseline
2026-01-30
Participant Flow
Participant milestones
| Measure |
NoCDO, CDOA, CDOB, CDOC
Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOA, CDOC, CDOB
Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOB, CDOA, CDOC
Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOB, CDOC, CDOA
Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOC, CDOA, CDOB
Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOC, CDOB, CDOA
Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
4
|
1
|
1
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
4
|
1
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Iterative Design of Custom Dynamic Orthoses
Baseline characteristics by cohort
| Measure |
NoCDO, CDOA, CDOB, CDOC
Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOA, CDOC, CDOB
n=4 Participants
Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOB, CDOA, CDOC
n=1 Participants
Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOB, CDOC, CDOA
n=1 Participants
Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOC, CDOA, CDOB
n=2 Participants
Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
NoCDO, CDOC, CDOB, CDOA
n=1 Participants
Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA.
Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
21.8 years
STANDARD_DEVIATION 2.1 • n=1581 Participants
|
23.0 years
STANDARD_DEVIATION 0.0 • n=4626 Participants
|
22.0 years
STANDARD_DEVIATION 0.0 • n=72 Participants
|
22.5 years
STANDARD_DEVIATION 0.7
|
19.0 years
STANDARD_DEVIATION 0.0 • n=140 Participants
|
21.8 years
STANDARD_DEVIATION 1.7 • n=58 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
1 Participants
n=140 Participants
|
4 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
2 Participants
|
0 Participants
n=140 Participants
|
5 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
2 Participants
|
1 Participants
n=140 Participants
|
9 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
2 Participants
|
0 Participants
n=140 Participants
|
7 Participants
n=58 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=72 Participants
|
0 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=58 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=72 Participants
|
0 Participants
|
1 Participants
n=140 Participants
|
2 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Joint Contact Stress-Time Exposure
|
4.1 MPa-s/gait cycle
Standard Deviation 2.9
|
2.7 MPa-s/gait cycle
Standard Deviation 0.6
|
3.9 MPa-s/gait cycle
Standard Deviation 2.9
|
3.5 MPa-s/gait cycle
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Peak dorsiflexion angle (degrees) during gait.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Ankle Range of Motion
|
16.3 degrees
Standard Deviation 2.8
|
15.5 degrees
Standard Deviation 3.6
|
17.8 degrees
Standard Deviation 3.3
|
16.0 degrees
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Peak ankle moment (Nm/kg) during gait.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Peak Ankle Moment
|
1.5 Nm/kg
Standard Deviation 0.1
|
1.4 Nm/kg
Standard Deviation 0.1
|
1.5 Nm/kg
Standard Deviation 0.1
|
1.5 Nm/kg
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Peak ankle power (W/kg) during gait.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Peak Ankle Power
|
1.6 W/kg
Standard Deviation 0.3
|
2.4 W/kg
Standard Deviation 0.4
|
2.9 W/kg
Standard Deviation 0.8
|
1.8 W/kg
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Force data (N) collected across the total foot measured between the foot and orthosis during gait.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Plantar Force (Total Foot)
|
428.6 N/kg
Standard Deviation 82.2
|
424.7 N/kg
Standard Deviation 83.3
|
406.5 N/kg
Standard Deviation 64.7
|
415.1 N/kg
Standard Deviation 80.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Plantar Force (Forefoot)
|
135.2 N/kg
Standard Deviation 42.0
|
149.9 N/kg
Standard Deviation 50.4
|
199.0 N/kg
Standard Deviation 42.6
|
165.7 N/kg
Standard Deviation 47.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Plantar Force (Midfoot)
|
81.6 N/kg
Standard Deviation 33.8
|
89.9 N/kg
Standard Deviation 32.9
|
65.4 N/kg
Standard Deviation 19.1
|
83.5 N/kg
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Plantar Force (Hindfoot)
|
211.8 N/kg
Standard Deviation 75.6
|
184.9 N/kg
Standard Deviation 62.5
|
142.0 N/kg
Standard Deviation 39.5
|
165.9 N/kg
Standard Deviation 47.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
The 4SST (s) is a standardized timed test of balance and agility.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Four Square Step Test (4SST)
|
6.1 seconds
Standard Deviation 1.7
|
5.8 seconds
Standard Deviation 1.5
|
5.5 seconds
Standard Deviation 1.7
|
6.1 seconds
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Sit to Stand 5 Times (STS5)
|
7.4 seconds
Standard Deviation 1.7
|
7.2 seconds
Standard Deviation 1.5
|
7.0 seconds
Standard Deviation 1.8
|
7.7 seconds
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Numerical Pain Rating Scale
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
0.0 score on a scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score. The survey asks users to indicate how much they agree with each statement on a scale from - Strongly Agree (5) to Strongly Disagree (0) with a Don't Know/Not Applicable option. The average score across all questions was calculated and reported, larger scores indicate a better outcome associated with that device. The maximum possible score is a 5 and the minimum possible score is a 0.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
The Orthotics Prosthetics Users' Survey (OPUS)
|
4.0 score on a scale
Standard Deviation 0.4
|
—
|
3.5 score on a scale
Standard Deviation 0.4
|
3.6 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Peak Soleus muscle forces (N) will be estimated using an Opensim model
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Soleus Muscle Force (N)
|
1106.6 N
Standard Deviation 358.2
|
1466.3 N
Standard Deviation 394.3
|
1813.0 N
Standard Deviation 505.7
|
1250.2 N
Standard Deviation 596.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC
Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Gastrocnemius Muscle Force (N)
|
1262.3 N
Standard Deviation 394.6
|
1210.5 N
Standard Deviation 240.2
|
1232.6 N
Standard Deviation 321.7
|
1333.9 N
Standard Deviation 425.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Modified Socket Comfort Score (Comfort)
|
8.0 score on a scale
Standard Deviation 1.9
|
—
|
6.6 score on a scale
Standard Deviation 2.2
|
6.8 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC
Comfort scores range from 0 = least smooth to 10 = most smooth.
Outcome measures
| Measure |
CDOB
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
CDOC
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA)
|
NoCDO
n=9 Participants
Participants completed testing without an orthosis.
|
CDOA
n=9 Participants
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
|
|---|---|---|---|---|
|
Modified Socket Comfort Score (Smoothness)
|
8.3 score on a scale
Standard Deviation 1.3
|
—
|
6.6 score on a scale
Standard Deviation 2.1
|
6.9 score on a scale
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineSemi-structured interviews will also be used to fully capture the patients' perspectives, experience, and opinions associated with the device options they experienced as part of the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineTiming of peak center of pressure velocity (percent stance) during gait.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineMagnitude of peak center of pressure velocity (m/s) during gait.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineElectromyography (EMG, % Maximum) of the Soleus during gait.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineElectromyography (EMG, % Maximum) of the Rectus Femoris during gait.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineElectromyography (EMG, % Maximum) of the Vastus Medialis during gait.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineElectromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineElectromyography (EMG, % Maximum) of the Tibialis Anterior during gait.
Outcome measures
Outcome data not reported
Adverse Events
NoCDO
CDOA
CDOB
CDOC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place