Adult ALL, Healthy
Conditions
Keywords
Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Knee Osteoarthritis
Brief summary
The proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has used foam wedges of different stiffness and height placed under the heel to alter CDO alignment and alter lower limb mechanics. Medial or lateral wedges have been used by individuals with unilateral knee osteoarthritis in effort to reduce knee loading. In this study, medial and lateral wedges will be placed in participants shoes, with the tall side of the wedge placed on the medial or lateral aspect of the shoes, and participants will walk at controlled and self-selected speeds and complete physical performance measures. Participants will also walk without a CDO. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.
Detailed description
The primary purpose of this line of research is to investigate the effects of combined carbon fiber custom dynamic orthosis (CDO) and medial or lateral wedge use on biomechanics during gait in effort to reduce unilateral knee compartment loading. The medial or lateral wedges are composed of foam, run the length of the foot, and will be placed so the tall side of the wedge is on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial and lateral edges of the foot respectively. The use of medial and lateral wedges to treat unilateral knee osteoarthritis (OA) has been studied previously, generally without combined use of a foot and ankle brace such as a CDO. Previous work has demonstrated that foam wedges, of different height and stiffness, placed under the heel of a CDO affects sagittal plane gait biomechanics, including ankle plantarflexion and knee extension moments. The additional support and restriction of motion at the ankle associated with CDO use may emphasize results seen at the knee with medial or lateral wedging. Therefore, the proposed effort is designed to evaluate how different medial or lateral wedges placed under a CDO influence frontal plane knee biomechanics during level over-ground gait and physical performance during tests of agility, speed, and lower limb power. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis. In this research study, data will be collected from a cohort of healthy adult participants with no history of lower limb injuries or functional deficits. Participants will be evaluated using a series of study measures under each of the four conditions; without a brace (NoCDO), with a brace and no wedge (CDO), with a brace and a medial wedge placed in the shoe (Medial), and with a brace and a lateral wedge placed in the shoe (Lateral). The wedge will be placed in a medial and lateral position to determine effectiveness of combined wedging and CDO use in treating both medial and lateral knee OA. Testing will be randomized for each participant. Participants will walk on a level-ground walkway at self-selected and controlled speeds. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that the CDO and wedge do not negatively affect physical function. Questionnaires will be used to evaluate participants' pain and perception of comfort and smoothness for each testing condition.
Interventions
DEVICEMedial 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.
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.
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the testing conditions to the greatest extent possible.
Intervention model description
Participants will be evaluated without a CDO (NoCDO), with a CDO and no wedge (CDO), with a CDO and a wedge placed on the medial aspect of the shoe (Medial), and with a CDO and a wedge placed on the lateral aspect of the shoe (Lateral)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 45 * Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months * Able to hop without pain * Able to perform a full squat without pain * Ability to speak and understand English
Exclusion criteria
* Medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months * Diagnosed with a moderate or severe brain injury * Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks * Injuries that would limit performance in this study * Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition) * Uncorrected visual or hearing impairment(s) * Require use of an assistive device * Unhealed wounds (cuts/abrasions) that would prevent CDO use * BMI \> 35 * Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale | Baseline | Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable. |
| Knee Range of Motion | Baseline | 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. |
| Peak Knee Moment | Baseline | 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). |
| Four Square Step Test (4SST) | Baseline | 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. |
| Modified Socket Comfort Score (Comfort) | Baseline | 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. |
| Modified Socket Comfort Score (Smoothness) | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sit to Stand 5 Times (STS5) | Baseline | 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. |
| Ankle Range of Motion | Baseline | 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. |
| Peak Ankle Moment | Baseline | 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). |
| Peak Ankle Power | Baseline | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Semi-Structured Interview | Baseline | Semi-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. |
| Center of Pressure Velocity Magnitude | Baseline | Magnitude of peak center of pressure velocity (m/s) during gait. |
| Center of Pressure Velocity Timing | Baseline | Timing of peak center of pressure velocity (percent stance) during gait. |
Countries
United States
Participant flow
Pre-assignment details
All participants completed study activities in each of the experimental conditions (NoCDO, CDO, Medial, Lateral) in a randomized order.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 3 |
| 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. | 3 |
| 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. | 5 |
| 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. | 2 |
| 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. | 2 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | NoCDO, CDO, Medial, Lateral | NoCDO, Medial, CDO, Lateral | NoCDO, Medial, Lateral, CDO | NoCDO, Lateral, Medial, CDO | NoCDO, Lateral, CDO, Medial | NoCDO, CDO, Lateral, Medial | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 4 Participants | 18 Participants |
| Age, Continuous | 26 years STANDARD_DEVIATION 9.8 | 20.0 years STANDARD_DEVIATION 1 | 23.4 years STANDARD_DEVIATION 3 | 22.5 years STANDARD_DEVIATION 4.9 | 34.5 years STANDARD_DEVIATION 14.8 | 23.8 years STANDARD_DEVIATION 4.5 | 25.0 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 5 Participants | 2 Participants | 2 Participants | 4 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 4 Participants | 2 Participants | 2 Participants | 5 Participants | 19 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 1 / 20 | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Four Square Step Test (4SST)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Four Square Step Test (4SST) | 5.6 seconds | Standard Deviation 0.9 |
| CDO Only | Four Square Step Test (4SST) | 5.8 seconds | Standard Deviation 1 |
| Medial | Four Square Step Test (4SST) | 5.7 seconds | Standard Deviation 1 |
| Lateral | Four Square Step Test (4SST) | 5.8 seconds | Standard Deviation 1 |
Primary
Knee Range of Motion
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Knee Range of Motion | 69.1 degrees | Standard Deviation 4.7 |
| CDO Only | Knee Range of Motion | 67.0 degrees | Standard Deviation 5.3 |
| Medial | Knee Range of Motion | 66.4 degrees | Standard Deviation 4.7 |
| Lateral | Knee Range of Motion | 66.1 degrees | Standard Deviation 4.4 |
Primary
Modified Socket Comfort Score (Comfort)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Modified Socket Comfort Score (Comfort) | 7.4 units on a scale | Standard Deviation 2.2 |
| CDO Only | Modified Socket Comfort Score (Comfort) | 6.7 units on a scale | Standard Deviation 2.6 |
| Medial | Modified Socket Comfort Score (Comfort) | 6.7 units on a scale | Standard Deviation 2.6 |
Primary
Modified Socket Comfort Score (Smoothness)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Modified Socket Comfort Score (Smoothness) | 6.9 units on a scale | Standard Deviation 1.9 |
| CDO Only | Modified Socket Comfort Score (Smoothness) | 6.7 units on a scale | Standard Deviation 2.1 |
| Medial | Modified Socket Comfort Score (Smoothness) | 6.8 units on a scale | Standard Deviation 2.4 |
Primary
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Numerical Pain Rating Scale | 0.0 units on a scale | Standard Deviation 0 |
| CDO Only | Numerical Pain Rating Scale | 0.3 units on a scale | Standard Deviation 0.7 |
| Medial | Numerical Pain Rating Scale | 0.6 units on a scale | Standard Deviation 1.1 |
| Lateral | Numerical Pain Rating Scale | 0.3 units on a scale | Standard Deviation 0.6 |
Primary
Peak Knee Moment
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Peak Knee Moment | 0.4 Nm/kg | Standard Deviation 0.1 |
| CDO Only | Peak Knee Moment | 0.4 Nm/kg | Standard Deviation 0.1 |
| Medial | Peak Knee Moment | 0.5 Nm/kg | Standard Deviation 0.1 |
| Lateral | Peak Knee Moment | 0.3 Nm/kg | Standard Deviation 0.1 |
Secondary
Ankle Range of Motion
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Ankle Range of Motion | 32.9 degrees | Standard Deviation 4 |
| CDO Only | Ankle Range of Motion | 14.0 degrees | Standard Deviation 3.1 |
| Medial | Ankle Range of Motion | 14.9 degrees | Standard Deviation 3 |
| Lateral | Ankle Range of Motion | 15.0 degrees | Standard Deviation 3.2 |
Secondary
Peak Ankle Moment
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.1 |
| CDO Only | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.1 |
| Medial | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.1 |
| Lateral | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.1 |
Secondary
Peak Ankle Power
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Peak Ankle Power | 3.2 W/kg | Standard Deviation 0.5 |
| CDO Only | Peak Ankle Power | 1.4 W/kg | Standard Deviation 0.3 |
| Medial | Peak Ankle Power | 1.4 W/kg | Standard Deviation 0.3 |
| Lateral | Peak Ankle Power | 1.5 W/kg | Standard Deviation 0.3 |
Secondary
Sit to Stand 5 Times (STS5)
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NoCDO | Sit to Stand 5 Times (STS5) | 6.4 seconds | Standard Deviation 1.1 |
| CDO Only | Sit to Stand 5 Times (STS5) | 7.4 seconds | Standard Deviation 1.5 |
| Medial | Sit to Stand 5 Times (STS5) | 7.4 seconds | Standard Deviation 1.6 |
| Lateral | Sit to Stand 5 Times (STS5) | 7.2 seconds | Standard Deviation 1.7 |
Other Pre-specified
Center of Pressure Velocity Magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Time frame: Baseline
Other Pre-specified
Center of Pressure Velocity Timing
Timing of peak center of pressure velocity (percent stance) during gait.
Time frame: Baseline
Other Pre-specified
Semi-Structured Interview
Semi-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.
Time frame: Baseline