Trial Outcomes & Findings for Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics (NCT NCT05209360)
NCT ID: NCT05209360
Last Updated: 2024-01-30
Results Overview
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane knee range of motion (degrees) was measured throughout the gait cycle.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2024-01-30
Participant Flow
All participants completed study activities in each of the experimental conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participant milestones
| Measure |
NoCDO, CDO, Lateral, Medial
Testing Order: NoCDO, CDO, Lateral, Medial
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, CDO, Medial, Lateral
Testing Order: NoCDO, CDO, Medial, Lateral
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Medial, CDO, Lateral
Testing Order: NoCDO, Medial, CDO, Lateral
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Medial, Lateral, CDO
Testing Order: NoCDO, Medial, Lateral, CDO
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Lateral, Medial, CDO
Testing Order: NoCDO, Lateral, Medial, CDO
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Lateral, CDO, Medial
Testing Order: NoCDO, Lateral, CDO, Medial
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
5
|
2
|
2
|
|
Overall Study
COMPLETED
|
5
|
3
|
2
|
5
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
NoCDO, CDO, Lateral, Medial
Testing Order: NoCDO, CDO, Lateral, Medial
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, CDO, Medial, Lateral
Testing Order: NoCDO, CDO, Medial, Lateral
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Medial, CDO, Lateral
Testing Order: NoCDO, Medial, CDO, Lateral
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Medial, Lateral, CDO
Testing Order: NoCDO, Medial, Lateral, CDO
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Lateral, Medial, CDO
Testing Order: NoCDO, Lateral, Medial, CDO
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Lateral, CDO, Medial
Testing Order: NoCDO, Lateral, CDO, Medial
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics
Baseline characteristics by cohort
| Measure |
NoCDO, CDO, Lateral, Medial
n=5 Participants
Testing Order: NoCDO, CDO, Lateral, Medial
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, CDO, Medial, Lateral
n=3 Participants
Testing Order: NoCDO, CDO, Medial, Lateral
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Medial, CDO, Lateral
n=3 Participants
Testing Order: NoCDO, Medial, CDO, Lateral
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Medial, Lateral, CDO
n=5 Participants
Testing Order: NoCDO, Medial, Lateral, CDO
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Lateral, Medial, CDO
n=2 Participants
Testing Order: NoCDO, Lateral, Medial, CDO
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
NoCDO, Lateral, CDO, Medial
n=2 Participants
Testing Order: NoCDO, Lateral, CDO, Medial
Medial or Lateral Wedge: A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic Orthosis: A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
23.8 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
26 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
20.0 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
23.4 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
22.5 years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
34.5 years
STANDARD_DEVIATION 14.8 • n=8 Participants
|
25.0 years
STANDARD_DEVIATION 5.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane knee range of motion (degrees) was measured throughout the gait cycle.
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=20 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Knee Range of Motion
|
69.1 degrees
Standard Deviation 4.7
|
67.0 degrees
Standard Deviation 5.3
|
66.4 degrees
Standard Deviation 4.7
|
66.1 degrees
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak knee valgus moment was measured during stance phase and normalized to the participants body weight (Nm/kg).
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=20 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Peak Knee Moment
|
0.4 Nm/kg
Standard Deviation 0.1
|
0.4 Nm/kg
Standard Deviation 0.1
|
0.5 Nm/kg
Standard Deviation 0.1
|
0.3 Nm/kg
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
The 4SST (s) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can.
Outcome measures
| Measure |
NoCDO
n=19 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=19 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=19 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Four Square Step Test (4SST)
|
5.6 seconds
Standard Deviation 0.9
|
5.8 seconds
Standard Deviation 1.0
|
5.7 seconds
Standard Deviation 1.0
|
5.8 seconds
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable.
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=20 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Numerical Pain Rating Scale
|
0.0 units on a scale
Standard Deviation 0.0
|
0.3 units on a scale
Standard Deviation 0.7
|
0.6 units on a scale
Standard Deviation 1.1
|
0.3 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants were asked to rate the comfort of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable.
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=19 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Modified Socket Comfort Score (Comfort)
|
7.4 units on a scale
Standard Deviation 2.2
|
6.7 units on a scale
Standard Deviation 2.6
|
6.7 units on a scale
Standard Deviation 2.6
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants were asked to rate the smoothness of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most smooth to 10 = least smooth.
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=19 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Modified Socket Comfort Score (Smoothness)
|
6.9 units on a scale
Standard Deviation 1.9
|
6.7 units on a scale
Standard Deviation 2.1
|
6.8 units on a scale
Standard Deviation 2.4
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane ankle range of motion (degrees) was measured throughout the gait cycle.
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=20 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Ankle Range of Motion
|
32.9 degrees
Standard Deviation 4.0
|
14.0 degrees
Standard Deviation 3.1
|
14.9 degrees
Standard Deviation 3.0
|
15.0 degrees
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak ankle plantarflexor moment was measured during stance phase and normalized to the participants body weight (Nm/kg).
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=20 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Peak Ankle Moment
|
1.4 Nm/kg
Standard Deviation 0.1
|
1.4 Nm/kg
Standard Deviation 0.1
|
1.4 Nm/kg
Standard Deviation 0.1
|
1.4 Nm/kg
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak ankle push-off power was measured during stance phase and normalized to the participants body weight (W/kg).
Outcome measures
| Measure |
NoCDO
n=20 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=20 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Peak Ankle Power
|
3.2 W/kg
Standard Deviation 0.5
|
1.4 W/kg
Standard Deviation 0.3
|
1.4 W/kg
Standard Deviation 0.3
|
1.5 W/kg
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: The study population consisted of healthy individuals ages 18-45 who met all of the study inclusion and none of the study exclusion criteria. All participants completed study activities in each of the testing conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are timed as they stand up and sit down 5 times as fast as possible.
Outcome measures
| Measure |
NoCDO
n=19 Participants
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=19 Participants
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=19 Participants
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=19 Participants
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
Sit to Stand 5 Times (STS5)
|
6.4 seconds
Standard Deviation 1.1
|
7.4 seconds
Standard Deviation 1.5
|
7.4 seconds
Standard Deviation 1.6
|
7.2 seconds
Standard Deviation 1.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineSemi-structured interviews will also be used to fully capture the patients' perspectives, experience, and opinions associated with the testing conditions 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
Adverse Events
NoCDO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CDO Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Medial
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lateral
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NoCDO
n=20 participants at risk
Participants completed testing without an orthosis or wedge, wearing shoes only.
|
CDO Only
n=20 participants at risk
Participants completed testing while wearing a CDO with no wedges.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Medial
n=20 participants at risk
Participants completed testing while wearing a CDO with a Medial wedges placed under the CDO footplate. The Medial wedge elevated the medial edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
Lateral
n=20 participants at risk
Participants completed testing while wearing a CDO with a Lateral wedges placed under the CDO footplate. The Lateral wedge elevated the lateral edge of the foot.
Carbon Fiber Custom Dynamic Orthosis (CDO): A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
|
|---|---|---|---|---|
|
General disorders
Discomfort
|
0.00%
0/20 • Study participants were monitored/assessed for adverse advents throughout the duration of the study visit, up to 4 hours. Participants were also instructed to call or email the research team if any adverse events related to the study occurred after completion of the study visit, up to 6 months.
\[Not Specified\]
|
5.0%
1/20 • Number of events 1 • Study participants were monitored/assessed for adverse advents throughout the duration of the study visit, up to 4 hours. Participants were also instructed to call or email the research team if any adverse events related to the study occurred after completion of the study visit, up to 6 months.
\[Not Specified\]
|
5.0%
1/20 • Number of events 1 • Study participants were monitored/assessed for adverse advents throughout the duration of the study visit, up to 4 hours. Participants were also instructed to call or email the research team if any adverse events related to the study occurred after completion of the study visit, up to 6 months.
\[Not Specified\]
|
5.0%
1/20 • Number of events 1 • Study participants were monitored/assessed for adverse advents throughout the duration of the study visit, up to 4 hours. Participants were also instructed to call or email the research team if any adverse events related to the study occurred after completion of the study visit, up to 6 months.
\[Not Specified\]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place