Ankle Fractures, Osteoarthritis Ankle, Post-traumatic Osteoarthritis
Conditions
Keywords
Carbon Fiber, Gait Analysis, Ankle Foot Orthosis, Arthritis, Biomechanics, Ankle, Adult
Brief summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.
Detailed description
The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) design on the forces and contact stress at the ankle, with the goal of reducing the development of post traumatic osteoarthritis (PTOA) in the ankle. Research suggests that ankle arthritis develops, in part, due to increased contact stresses within the ankle joint following fracture. It is expected that reducing articular contact stress at the ankle has the potential to delay or prevent the development of PTOA. CDOs have been shown to significantly improve function following extremity injury, and show promise for offloading the injured limb after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate how different CDO design factors influence offloading and therefore the reduction of forces and articular contact stress at the ankle. Adult participants will be evaluated while wearing carbon fiber braces of varied geometry. The primary dependent measure is ankle joint contact stress. Following consent and enrollment computerized tomography (CT) images will be used to determine the geometry of the joint articular surfaces. Ankle contact stress will be calculated using discrete element analysis and biomechanical data collected in subsequent data collection. Participants will be cast and fit for three CDOs with varied geometry. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.
Interventions
DEVICECustom Carbon Fiber Dynamic Orthosis (CDO)
The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
Sponsors
University of Iowa
University of Delaware
Bio-Mechanical Composites
Fabtech Systems
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to the different design variations of each device, and will only be introduced to each device as CDO-A, CDO-B or CDO-C.
Intervention model description
All participants will be cast and fit with three carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results. Multiple rounds of evaluation (\ 5 rounds) with small groups of participants in each round (n=\ 6) will be used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
TIBIAL PILON FRACTURE PARTICIPANTS: Inclusion Criteria: * Ages: 18-65 * Sustained unilateral fracture of the tibial pilon within the preceding 5 years * The fracture has completely healed * Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.) * Ability to walk at a slow to moderate pace * Shoe size between women's 8 and 13.5 or men's 6.5 and 13 * Ability to read and write in English and provide written informed consent * Individuals with elevated contact stress according to model generated using PedCAT standing CT images (will be answered after completing visit one)
Exclusion criteria
* Pain \> 6/10 while walking * Increase in pain during testing of 3/10 or greater * Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity * Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease) * Wounds to the calf that would prevent CDO fitting * Fractures secondary to neuropathy or severe osteopenia * Classification as non-ambulatory * Previous fractures near the tibial pilon on the involved limb * Surgery on involved limb anticipated in the next 6 months * Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * BMI greater than 40 * 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. HEALTHY ABLE-BODIED PARTICIPANTS: Patient Inclusion Criteria * Between the ages of 18 and 65 * Shoe size between women's 8 and 13.5 or men's 6.5 and 13 * Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months * Full active range of motion of the bilateral lower extremities and spine * Ability to hop without pain * Ability to perform a full squat without pain * Ability to read and write in English and provide written informed consent Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plantar Force (Total Foot) | Baseline | Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk. |
| Peak Plantar Force (Hindfoot) | Baseline | Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO. |
| Joint Contact Stress Time Exposure (Model Estimated) | Baseline | Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome. |
| Peak Plantar Force (Midfoot) | Baseline | Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO. |
| Peak Plantar Force (Forefoot) | Baseline | Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO. |
| Plantar Force Impulse (Total Foot) | Baseline | Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk. |
| Plantar Force Impulse (Hindfoot) | Baseline | Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO. |
| Plantar Force Impulse (Midfoot) | Baseline | Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO. |
| Plantar Force Impulse (Forefoot) | Baseline | Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO. |
| Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | Baseline | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain. |
| Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | Baseline | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain |
| Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | Baseline | The 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. |
| Participant Device Preference (First Preferred Condition) | Baseline | Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire. |
| Participant Device Preference (Second Preferred Condition) | Baseline | Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred). |
| Participant Device Preference (Third Preferred Condition) | Baseline | Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred). |
| Participant Device Preference (Fourth Preferred Condition) | Baseline | Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Soleus Muscle Force (Model Estimated) | Baseline | Peak soleus muscle force (N) during gait was estimated using a participant specific musculoskeletal model. |
| Peak Gastrocnemius Muscle Force (Model Estimated) | Baseline | Peak gastrocnemius muscle force (N) during gait was estimated using a participant specific musculoskeletal model. |
| Ankle Range of Motion | Baseline | Peak ankle dorsiflexion (degrees) during gait. |
| Peak Ankle Moment | Baseline | Peak ankle plantarflexion moment (Nm/kg) during gait. |
| Peak Ankle Power | Baseline | Peak ankle push-off power (W/kg) during gait. |
| Four Square Step Test (4SST) | Baseline | The 4SST (s) is a standardized timed test of balance and agility. One inch pipe is placed on the floor in the shape of a Maltese cross and participants are instructed to begin in the back left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square. |
| Sit to Stand 5 Times (STS5) | Baseline | STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to start the test sitting with their arms folded across their chest and with their back against a standard chair. Patients are then instructed to stand up and sit down 5 times as fast as possible, avoiding touching their back to the chair during each repetition. The time to complete all five continuous repetitions is reported. |
| The Orthotics Prosthetics Users' Survey (OPUS) | Baseline | Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome. |
| Modified Socket Comfort Score (Comfort) | Baseline | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. Higher scores are better as they indicate a more comfortable device. |
| Modified Socket Comfort Score (Smoothness) | Baseline | Comfort scores range from 0 = least smooth to 10 = most smooth. Higher scores are better as they indicate a smoother rollover with the device. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason M Wilken, PT, PhD
University of Iowa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg | 1 |
| Group 1: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg | 1 |
| Group 1: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg | 3 |
| Group 1: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg | 0 |
| Group 1: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg | 2 |
| Group 1: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg | 0 |
| Group 2: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro. | 2 |
| Group 2: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro. | 2 |
| Group 2: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro. | 1 |
| Group 2: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro. | 1 |
| Group 2: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro. | 0 |
| Group 2: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro. | 0 |
| Group 3: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N. | 1 |
| Group 3: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N. | 1 |
| Group 3: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N. | 2 |
| Group 3: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N. | 2 |
| Group 3: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N. | 1 |
| Group 3: 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 full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N. | 2 |
| Total | 22 |
Baseline characteristics
| Characteristic | Group 1: NoCDO, CDOA, CDOB, CDOC | Group 1: NoCDO, CDOC, CDOA, CDOB | Group 1: NoCDO, CDOB, CDOC, CDOA | Group 1: NoCDO, CDOB, CDOA, CDOC | Group 1: NoCDO, CDOA, CDOC, CDOB | Group 1: NoCDO, CDOC, CDOB, CDOA | Group 2: NoCDO, CDOA, CDOB, CDOC | Group 2: NoCDO, CDOA, CDOC, CDOB | Group 2: NoCDO, CDOB, CDOA, CDOC | Group 2: NoCDO, CDOB, CDOC, CDOA | Group 2: NoCDO, CDOC, CDOA, CDOB | Group 2: NoCDO, CDOC, CDOB, CDOA | Group 3: NoCDO, CDOA, CDOB, CDOC | Group 3: NoCDO, CDOA, CDOC, CDOB | Group 3: NoCDO, CDOB, CDOA, CDOC | Group 3: NoCDO, CDOB, CDOC, CDOA | Group 3: NoCDO, CDOC, CDOA, CDOB | Group 3: NoCDO, CDOC, CDOB, CDOA | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 22 Participants |
| Age, Continuous | 32.0 years STANDARD_DEVIATION 0 | 27.0 years STANDARD_DEVIATION 9.9 | — | 41.0 years STANDARD_DEVIATION 11.3 | 40.0 years STANDARD_DEVIATION 0 | — | 35.0 years STANDARD_DEVIATION 21.2 | 59.0 years STANDARD_DEVIATION 0 | 58.0 years STANDARD_DEVIATION 0 | 39.0 years STANDARD_DEVIATION 0 | — | — | 56.0 years STANDARD_DEVIATION 0 | 23.0 years STANDARD_DEVIATION 0 | 34.5 years STANDARD_DEVIATION 3.5 | 26.0 years STANDARD_DEVIATION 9.9 | 29.0 years STANDARD_DEVIATION 0 | 38.5 years STANDARD_DEVIATION 16.3 | 38.5 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | — | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | — | 3 Participants | 1 Participants | — | 2 Participants | 2 Participants | 1 Participants | 1 Participants | — | — | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | 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 | 0 Participants | — | — | 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 | 0 Participants | — | — | 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 | 0 Participants | — | — | 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 | 0 Participants | — | — | 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 | 0 Participants | — | — | 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 | — | 0 Participants | 0 Participants | — | 1 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | — | 3 Participants | 1 Participants | — | 1 Participants | 2 Participants | 1 Participants | 1 Participants | — | — | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 21 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | — | — | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | — | 3 Participants | 1 Participants | — | 2 Participants | 1 Participants | 0 Participants | 0 Participants | — | — | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Joint Contact Stress Time Exposure (Model Estimated)
Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.
Time frame: Baseline
Population: Peak joint contact stress time exposure was only calculated for participants in group 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Joint Contact Stress Time Exposure (Model Estimated) | 4.44 MPa-s/gait cycle | Standard Deviation 2.8 |
| Group 1: CDOA | Joint Contact Stress Time Exposure (Model Estimated) | 3.97 MPa-s/gait cycle | Standard Deviation 3.33 |
| Group 1: CDOB | Joint Contact Stress Time Exposure (Model Estimated) | 4.08 MPa-s/gait cycle | Standard Deviation 2.96 |
| Group 1: CDOC | Joint Contact Stress Time Exposure (Model Estimated) | 4.25 MPa-s/gait cycle | Standard Deviation 2.94 |
Primary
Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.9 score on a scale | Standard Deviation 1.2 |
| Group 1: CDOA | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.4 score on a scale | Standard Deviation 0.8 |
| Group 1: CDOB | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.6 score on a scale | Standard Deviation 1.1 |
| Group 1: CDOC | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.4 score on a scale | Standard Deviation 0.8 |
| Group 2: NoCDO | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 2: CDOA | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 2: CDOB | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 2: CDOC | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 3: NoCDO | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.1 score on a scale | Standard Deviation 0.3 |
| Group 3: CDOA | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 3: CDOB | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.1 score on a scale | Standard Deviation 0.3 |
| Group 3: CDOC | Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS) | 0.1 score on a scale | Standard Deviation 0.3 |
Primary
Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.6 score on a scale | Standard Deviation 1.1 |
| Group 1: CDOA | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.4 score on a scale | Standard Deviation 0.8 |
| Group 1: CDOB | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.4 score on a scale | Standard Deviation 0.8 |
| Group 1: CDOC | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.6 score on a scale | Standard Deviation 1.1 |
| Group 2: NoCDO | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 2: CDOA | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 2: CDOB | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 2: CDOC | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 3: NoCDO | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 3: CDOA | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 3: CDOB | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
| Group 3: CDOC | Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS) | 0.0 score on a scale | Standard Deviation 0 |
Primary
Participant Device Preference (First Preferred Condition)
Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: NoCDO | Participant Device Preference (First Preferred Condition) | 4 Participants |
| Group 1: CDOA | Participant Device Preference (First Preferred Condition) | 0 Participants |
| Group 1: CDOB | Participant Device Preference (First Preferred Condition) | 0 Participants |
| Group 1: CDOC | Participant Device Preference (First Preferred Condition) | 3 Participants |
| Group 2: NoCDO | Participant Device Preference (First Preferred Condition) | 5 Participants |
| Group 2: CDOA | Participant Device Preference (First Preferred Condition) | 1 Participants |
| Group 2: CDOB | Participant Device Preference (First Preferred Condition) | 0 Participants |
| Group 2: CDOC | Participant Device Preference (First Preferred Condition) | 0 Participants |
| Group 3: NoCDO | Participant Device Preference (First Preferred Condition) | 9 Participants |
| Group 3: CDOA | Participant Device Preference (First Preferred Condition) | 0 Participants |
| Group 3: CDOB | Participant Device Preference (First Preferred Condition) | 0 Participants |
| Group 3: CDOC | Participant Device Preference (First Preferred Condition) | 0 Participants |
Primary
Participant Device Preference (Fourth Preferred Condition)
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: NoCDO | Participant Device Preference (Fourth Preferred Condition) | 1 Participants |
| Group 1: CDOA | Participant Device Preference (Fourth Preferred Condition) | 3 Participants |
| Group 1: CDOB | Participant Device Preference (Fourth Preferred Condition) | 3 Participants |
| Group 1: CDOC | Participant Device Preference (Fourth Preferred Condition) | 0 Participants |
| Group 2: NoCDO | Participant Device Preference (Fourth Preferred Condition) | 0 Participants |
| Group 2: CDOA | Participant Device Preference (Fourth Preferred Condition) | 4 Participants |
| Group 2: CDOB | Participant Device Preference (Fourth Preferred Condition) | 2 Participants |
| Group 2: CDOC | Participant Device Preference (Fourth Preferred Condition) | 0 Participants |
| Group 3: NoCDO | Participant Device Preference (Fourth Preferred Condition) | 0 Participants |
| Group 3: CDOA | Participant Device Preference (Fourth Preferred Condition) | 4 Participants |
| Group 3: CDOB | Participant Device Preference (Fourth Preferred Condition) | 0 Participants |
| Group 3: CDOC | Participant Device Preference (Fourth Preferred Condition) | 5 Participants |
Primary
Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)
The 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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: NoCDO | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 1: CDOA | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 1: CDOB | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 1: CDOC | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 2 Participants |
| Group 2: NoCDO | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 2: CDOA | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 2: CDOB | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 2: CDOC | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 3: NoCDO | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 1 Participants |
| Group 3: CDOA | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 3 Participants |
| Group 3: CDOB | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 3 Participants |
| Group 3: CDOC | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 2 Participants |
| Group 3: NoCDO, CDOC, CDOB, CDOA | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 2 Participants |
| Group 3: NoCDO, CDOB, CDOC, CDOA | Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC) | 2 Participants |
Primary
Participant Device Preference (Second Preferred Condition)
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: NoCDO | Participant Device Preference (Second Preferred Condition) | 1 Participants |
| Group 1: CDOA | Participant Device Preference (Second Preferred Condition) | 2 Participants |
| Group 1: CDOB | Participant Device Preference (Second Preferred Condition) | 1 Participants |
| Group 1: CDOC | Participant Device Preference (Second Preferred Condition) | 3 Participants |
| Group 2: NoCDO | Participant Device Preference (Second Preferred Condition) | 1 Participants |
| Group 2: CDOA | Participant Device Preference (Second Preferred Condition) | 1 Participants |
| Group 2: CDOB | Participant Device Preference (Second Preferred Condition) | 1 Participants |
| Group 2: CDOC | Participant Device Preference (Second Preferred Condition) | 3 Participants |
| Group 3: NoCDO | Participant Device Preference (Second Preferred Condition) | 0 Participants |
| Group 3: CDOA | Participant Device Preference (Second Preferred Condition) | 3 Participants |
| Group 3: CDOB | Participant Device Preference (Second Preferred Condition) | 4 Participants |
| Group 3: CDOC | Participant Device Preference (Second Preferred Condition) | 2 Participants |
Primary
Participant Device Preference (Third Preferred Condition)
Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: NoCDO | Participant Device Preference (Third Preferred Condition) | 1 Participants |
| Group 1: CDOA | Participant Device Preference (Third Preferred Condition) | 2 Participants |
| Group 1: CDOB | Participant Device Preference (Third Preferred Condition) | 3 Participants |
| Group 1: CDOC | Participant Device Preference (Third Preferred Condition) | 1 Participants |
| Group 2: NoCDO | Participant Device Preference (Third Preferred Condition) | 0 Participants |
| Group 2: CDOA | Participant Device Preference (Third Preferred Condition) | 0 Participants |
| Group 2: CDOB | Participant Device Preference (Third Preferred Condition) | 3 Participants |
| Group 2: CDOC | Participant Device Preference (Third Preferred Condition) | 3 Participants |
| Group 3: NoCDO | Participant Device Preference (Third Preferred Condition) | 0 Participants |
| Group 3: CDOA | Participant Device Preference (Third Preferred Condition) | 2 Participants |
| Group 3: CDOB | Participant Device Preference (Third Preferred Condition) | 5 Participants |
| Group 3: CDOC | Participant Device Preference (Third Preferred Condition) | 2 Participants |
Primary
Peak Plantar Force (Forefoot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Plantar Force (Forefoot) | 9.7 N/kg | Standard Deviation 1 |
| Group 1: CDOA | Peak Plantar Force (Forefoot) | 7.7 N/kg | Standard Deviation 1.3 |
| Group 1: CDOB | Peak Plantar Force (Forefoot) | 7.7 N/kg | Standard Deviation 0.9 |
| Group 1: CDOC | Peak Plantar Force (Forefoot) | 7.7 N/kg | Standard Deviation 0.9 |
| Group 2: NoCDO | Peak Plantar Force (Forefoot) | 9.0 N/kg | Standard Deviation 0.6 |
| Group 2: CDOA | Peak Plantar Force (Forefoot) | 7.1 N/kg | Standard Deviation 1.9 |
| Group 2: CDOB | Peak Plantar Force (Forefoot) | 6.4 N/kg | Standard Deviation 2.3 |
| Group 2: CDOC | Peak Plantar Force (Forefoot) | 6.9 N/kg | Standard Deviation 1.5 |
| Group 3: NoCDO | Peak Plantar Force (Forefoot) | 10.3 N/kg | Standard Deviation 0.9 |
| Group 3: CDOA | Peak Plantar Force (Forefoot) | 7.8 N/kg | Standard Deviation 1.8 |
| Group 3: CDOB | Peak Plantar Force (Forefoot) | 8.0 N/kg | Standard Deviation 2 |
| Group 3: CDOC | Peak Plantar Force (Forefoot) | 7.9 N/kg | Standard Deviation 2 |
Primary
Peak Plantar Force (Hindfoot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Plantar Force (Hindfoot) | 8.7 N/kg | Standard Deviation 1.2 |
| Group 1: CDOA | Peak Plantar Force (Hindfoot) | 7.2 N/kg | Standard Deviation 0.9 |
| Group 1: CDOB | Peak Plantar Force (Hindfoot) | 7.7 N/kg | Standard Deviation 0.8 |
| Group 1: CDOC | Peak Plantar Force (Hindfoot) | 7.5 N/kg | Standard Deviation 0.9 |
| Group 2: NoCDO | Peak Plantar Force (Hindfoot) | 9.2 N/kg | Standard Deviation 2 |
| Group 2: CDOA | Peak Plantar Force (Hindfoot) | 8.2 N/kg | Standard Deviation 1.8 |
| Group 2: CDOB | Peak Plantar Force (Hindfoot) | 7.7 N/kg | Standard Deviation 1.8 |
| Group 2: CDOC | Peak Plantar Force (Hindfoot) | 7.8 N/kg | Standard Deviation 2.1 |
| Group 3: NoCDO | Peak Plantar Force (Hindfoot) | 8.9 N/kg | Standard Deviation 1.4 |
| Group 3: CDOA | Peak Plantar Force (Hindfoot) | 7.5 N/kg | Standard Deviation 1 |
| Group 3: CDOB | Peak Plantar Force (Hindfoot) | 7.6 N/kg | Standard Deviation 1.5 |
| Group 3: CDOC | Peak Plantar Force (Hindfoot) | 7.8 N/kg | Standard Deviation 1.5 |
Primary
Peak Plantar Force (Midfoot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Plantar Force (Midfoot) | 3.0 N/kg | Standard Deviation 0.7 |
| Group 1: CDOA | Peak Plantar Force (Midfoot) | 2.8 N/kg | Standard Deviation 0.9 |
| Group 1: CDOB | Peak Plantar Force (Midfoot) | 3.1 N/kg | Standard Deviation 1.3 |
| Group 1: CDOC | Peak Plantar Force (Midfoot) | 2.9 N/kg | Standard Deviation 0.5 |
| Group 2: NoCDO | Peak Plantar Force (Midfoot) | 2.5 N/kg | Standard Deviation 0.9 |
| Group 2: CDOA | Peak Plantar Force (Midfoot) | 1.6 N/kg | Standard Deviation 0.2 |
| Group 2: CDOB | Peak Plantar Force (Midfoot) | 1.7 N/kg | Standard Deviation 0.4 |
| Group 2: CDOC | Peak Plantar Force (Midfoot) | 2.0 N/kg | Standard Deviation 0.7 |
| Group 3: NoCDO | Peak Plantar Force (Midfoot) | 2.1 N/kg | Standard Deviation 0.5 |
| Group 3: CDOA | Peak Plantar Force (Midfoot) | 2.2 N/kg | Standard Deviation 0.7 |
| Group 3: CDOB | Peak Plantar Force (Midfoot) | 2.3 N/kg | Standard Deviation 0.6 |
| Group 3: CDOC | Peak Plantar Force (Midfoot) | 2.3 N/kg | Standard Deviation 0.6 |
Primary
Peak Plantar Force (Total Foot)
Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Plantar Force (Total Foot) | 11.3 N/kg | Standard Deviation 1.2 |
| Group 1: CDOA | Peak Plantar Force (Total Foot) | 10.5 N/kg | Standard Deviation 0.8 |
| Group 1: CDOB | Peak Plantar Force (Total Foot) | 10.7 N/kg | Standard Deviation 0.7 |
| Group 1: CDOC | Peak Plantar Force (Total Foot) | 10.4 N/kg | Standard Deviation 0.7 |
| Group 2: NoCDO | Peak Plantar Force (Total Foot) | 11.0 N/kg | Standard Deviation 1.3 |
| Group 2: CDOA | Peak Plantar Force (Total Foot) | 10.6 N/kg | Standard Deviation 0.8 |
| Group 2: CDOB | Peak Plantar Force (Total Foot) | 10.2 N/kg | Standard Deviation 0.7 |
| Group 2: CDOC | Peak Plantar Force (Total Foot) | 10.5 N/kg | Standard Deviation 1 |
| Group 3: NoCDO | Peak Plantar Force (Total Foot) | 11.0 N/kg | Standard Deviation 0.9 |
| Group 3: CDOA | Peak Plantar Force (Total Foot) | 10.3 N/kg | Standard Deviation 0.9 |
| Group 3: CDOB | Peak Plantar Force (Total Foot) | 10.5 N/kg | Standard Deviation 1.2 |
| Group 3: CDOC | Peak Plantar Force (Total Foot) | 10.6 N/kg | Standard Deviation 1 |
Primary
Plantar Force Impulse (Forefoot)
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Plantar Force Impulse (Forefoot) | 2.7 Ns/kg | Standard Deviation 0.3 |
| Group 1: CDOA | Plantar Force Impulse (Forefoot) | 2.3 Ns/kg | Standard Deviation 0.2 |
| Group 1: CDOB | Plantar Force Impulse (Forefoot) | 2.2 Ns/kg | Standard Deviation 0.2 |
| Group 1: CDOC | Plantar Force Impulse (Forefoot) | 2.3 Ns/kg | Standard Deviation 0.1 |
| Group 2: NoCDO | Plantar Force Impulse (Forefoot) | 2.5 Ns/kg | Standard Deviation 0.3 |
| Group 2: CDOA | Plantar Force Impulse (Forefoot) | 2.6 Ns/kg | Standard Deviation 0.7 |
| Group 2: CDOB | Plantar Force Impulse (Forefoot) | 2.4 Ns/kg | Standard Deviation 0.8 |
| Group 2: CDOC | Plantar Force Impulse (Forefoot) | 2.5 Ns/kg | Standard Deviation 0.6 |
| Group 3: NoCDO | Plantar Force Impulse (Forefoot) | 2.8 Ns/kg | Standard Deviation 0.5 |
| Group 3: CDOA | Plantar Force Impulse (Forefoot) | 2.3 Ns/kg | Standard Deviation 0.5 |
| Group 3: CDOB | Plantar Force Impulse (Forefoot) | 2.3 Ns/kg | Standard Deviation 0.6 |
| Group 3: CDOC | Plantar Force Impulse (Forefoot) | 2.2 Ns/kg | Standard Deviation 0.6 |
Primary
Plantar Force Impulse (Hindfoot)
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Plantar Force Impulse (Hindfoot) | 2.0 Ns/kg | Standard Deviation 0.4 |
| Group 1: CDOA | Plantar Force Impulse (Hindfoot) | 2.2 Ns/kg | Standard Deviation 0.5 |
| Group 1: CDOB | Plantar Force Impulse (Hindfoot) | 2.5 Ns/kg | Standard Deviation 0.5 |
| Group 1: CDOC | Plantar Force Impulse (Hindfoot) | 2.2 Ns/kg | Standard Deviation 0.4 |
| Group 2: NoCDO | Plantar Force Impulse (Hindfoot) | 2.1 Ns/kg | Standard Deviation 0.4 |
| Group 2: CDOA | Plantar Force Impulse (Hindfoot) | 2.6 Ns/kg | Standard Deviation 0.8 |
| Group 2: CDOB | Plantar Force Impulse (Hindfoot) | 2.7 Ns/kg | Standard Deviation 0.9 |
| Group 2: CDOC | Plantar Force Impulse (Hindfoot) | 2.4 Ns/kg | Standard Deviation 0.8 |
| Group 3: NoCDO | Plantar Force Impulse (Hindfoot) | 2.1 Ns/kg | Standard Deviation 0.5 |
| Group 3: CDOA | Plantar Force Impulse (Hindfoot) | 2.5 Ns/kg | Standard Deviation 0.4 |
| Group 3: CDOB | Plantar Force Impulse (Hindfoot) | 2.6 Ns/kg | Standard Deviation 0.7 |
| Group 3: CDOC | Plantar Force Impulse (Hindfoot) | 2.7 Ns/kg | Standard Deviation 0.6 |
Primary
Plantar Force Impulse (Midfoot)
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Plantar Force Impulse (Midfoot) | 1.1 Ns/kg | Standard Deviation 0.3 |
| Group 1: CDOA | Plantar Force Impulse (Midfoot) | 1.3 Ns/kg | Standard Deviation 0.4 |
| Group 1: CDOB | Plantar Force Impulse (Midfoot) | 1.3 Ns/kg | Standard Deviation 0.5 |
| Group 1: CDOC | Plantar Force Impulse (Midfoot) | 1.2 Ns/kg | Standard Deviation 0.2 |
| Group 2: NoCDO | Plantar Force Impulse (Midfoot) | 0.8 Ns/kg | Standard Deviation 0.3 |
| Group 2: CDOA | Plantar Force Impulse (Midfoot) | 0.6 Ns/kg | Standard Deviation 0.1 |
| Group 2: CDOB | Plantar Force Impulse (Midfoot) | 0.6 Ns/kg | Standard Deviation 0.2 |
| Group 2: CDOC | Plantar Force Impulse (Midfoot) | 0.7 Ns/kg | Standard Deviation 0.2 |
| Group 3: NoCDO | Plantar Force Impulse (Midfoot) | 0.7 Ns/kg | Standard Deviation 0.2 |
| Group 3: CDOA | Plantar Force Impulse (Midfoot) | 1.0 Ns/kg | Standard Deviation 0.3 |
| Group 3: CDOB | Plantar Force Impulse (Midfoot) | 1.0 Ns/kg | Standard Deviation 0.2 |
| Group 3: CDOC | Plantar Force Impulse (Midfoot) | 0.9 Ns/kg | Standard Deviation 0.2 |
Primary
Plantar Force Impulse (Total Foot)
Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Plantar Force Impulse (Total Foot) | 5.8 Ns/kg | Standard Deviation 0.5 |
| Group 1: CDOA | Plantar Force Impulse (Total Foot) | 5.7 Ns/kg | Standard Deviation 0.3 |
| Group 1: CDOB | Plantar Force Impulse (Total Foot) | 6.0 Ns/kg | Standard Deviation 0.3 |
| Group 1: CDOC | Plantar Force Impulse (Total Foot) | 5.7 Ns/kg | Standard Deviation 0.3 |
| Group 2: NoCDO | Plantar Force Impulse (Total Foot) | 5.4 Ns/kg | Standard Deviation 0.3 |
| Group 2: CDOA | Plantar Force Impulse (Total Foot) | 5.8 Ns/kg | Standard Deviation 0.3 |
| Group 2: CDOB | Plantar Force Impulse (Total Foot) | 5.7 Ns/kg | Standard Deviation 0.4 |
| Group 2: CDOC | Plantar Force Impulse (Total Foot) | 5.9 Ns/kg | Standard Deviation 0.4 |
| Group 3: NoCDO | Plantar Force Impulse (Total Foot) | 5.7 Ns/kg | Standard Deviation 0.4 |
| Group 3: CDOA | Plantar Force Impulse (Total Foot) | 5.8 Ns/kg | Standard Deviation 0.6 |
| Group 3: CDOB | Plantar Force Impulse (Total Foot) | 5.9 Ns/kg | Standard Deviation 0.7 |
| Group 3: CDOC | Plantar Force Impulse (Total Foot) | 5.9 Ns/kg | Standard Deviation 0.7 |
Secondary
Ankle Range of Motion
Peak ankle dorsiflexion (degrees) during gait.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Ankle Range of Motion | 17.0 degree | Standard Deviation 2.5 |
| Group 1: CDOA | Ankle Range of Motion | 13.3 degree | Standard Deviation 1.9 |
| Group 1: CDOB | Ankle Range of Motion | 12.9 degree | Standard Deviation 1.6 |
| Group 1: CDOC | Ankle Range of Motion | 13.6 degree | Standard Deviation 1.8 |
| Group 2: NoCDO | Ankle Range of Motion | 16.3 degree | Standard Deviation 2.5 |
| Group 2: CDOA | Ankle Range of Motion | 12.3 degree | Standard Deviation 1.4 |
| Group 2: CDOB | Ankle Range of Motion | 12.4 degree | Standard Deviation 1.3 |
| Group 2: CDOC | Ankle Range of Motion | 12.3 degree | Standard Deviation 1.4 |
| Group 3: NoCDO | Ankle Range of Motion | 17.1 degree | Standard Deviation 3.2 |
| Group 3: CDOA | Ankle Range of Motion | 13.4 degree | Standard Deviation 2.5 |
| Group 3: CDOB | Ankle Range of Motion | 12.8 degree | Standard Deviation 2.6 |
| Group 3: CDOC | Ankle Range of Motion | 12.6 degree | Standard Deviation 2.4 |
Secondary
Four Square Step Test (4SST)
The 4SST (s) is a standardized timed test of balance and agility. One inch pipe is placed on the floor in the shape of a Maltese cross and participants are instructed to begin in the back left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Four Square Step Test (4SST) | 6.6 seconds | Standard Deviation 1.7 |
| Group 1: CDOA | Four Square Step Test (4SST) | 6.6 seconds | Standard Deviation 1.5 |
| Group 1: CDOB | Four Square Step Test (4SST) | 6.5 seconds | Standard Deviation 1.5 |
| Group 1: CDOC | Four Square Step Test (4SST) | 6.3 seconds | Standard Deviation 1.4 |
| Group 2: NoCDO | Four Square Step Test (4SST) | 7.1 seconds | Standard Deviation 2.9 |
| Group 2: CDOA | Four Square Step Test (4SST) | 7.2 seconds | Standard Deviation 2.4 |
| Group 2: CDOB | Four Square Step Test (4SST) | 7.0 seconds | Standard Deviation 2.2 |
| Group 2: CDOC | Four Square Step Test (4SST) | 6.7 seconds | Standard Deviation 2 |
| Group 3: NoCDO | Four Square Step Test (4SST) | 6.1 seconds | Standard Deviation 0.9 |
| Group 3: CDOA | Four Square Step Test (4SST) | 6.3 seconds | Standard Deviation 1.1 |
| Group 3: CDOB | Four Square Step Test (4SST) | 6.4 seconds | Standard Deviation 1 |
| Group 3: CDOC | Four Square Step Test (4SST) | 6.5 seconds | Standard Deviation 1.1 |
Secondary
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. Higher scores are better as they indicate a more comfortable device.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Modified Socket Comfort Score (Comfort) | 6.3 score on a scale | Standard Deviation 1.8 |
| Group 1: CDOA | Modified Socket Comfort Score (Comfort) | 6.4 score on a scale | Standard Deviation 2 |
| Group 1: CDOB | Modified Socket Comfort Score (Comfort) | 7.6 score on a scale | Standard Deviation 1.3 |
| Group 1: CDOC | Modified Socket Comfort Score (Comfort) | 7.0 score on a scale | Standard Deviation 1.3 |
| Group 2: NoCDO | Modified Socket Comfort Score (Comfort) | 7.0 score on a scale | Standard Deviation 1.4 |
| Group 2: CDOA | Modified Socket Comfort Score (Comfort) | 7.7 score on a scale | Standard Deviation 0.8 |
| Group 2: CDOB | Modified Socket Comfort Score (Comfort) | 7.1 score on a scale | Standard Deviation 2.6 |
| Group 2: CDOC | Modified Socket Comfort Score (Comfort) | 7.4 score on a scale | Standard Deviation 2.2 |
| Group 3: NoCDO | Modified Socket Comfort Score (Comfort) | 6.7 score on a scale | Standard Deviation 2.2 |
Secondary
Modified Socket Comfort Score (Smoothness)
Comfort scores range from 0 = least smooth to 10 = most smooth. Higher scores are better as they indicate a smoother rollover with the device.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Modified Socket Comfort Score (Smoothness) | 6.1 score on a scale | Standard Deviation 1.6 |
| Group 1: CDOA | Modified Socket Comfort Score (Smoothness) | 5.7 score on a scale | Standard Deviation 2.1 |
| Group 1: CDOB | Modified Socket Comfort Score (Smoothness) | 7.7 score on a scale | Standard Deviation 2 |
| Group 1: CDOC | Modified Socket Comfort Score (Smoothness) | 6.5 score on a scale | Standard Deviation 2.1 |
| Group 2: NoCDO | Modified Socket Comfort Score (Smoothness) | 6.8 score on a scale | Standard Deviation 0.8 |
| Group 2: CDOA | Modified Socket Comfort Score (Smoothness) | 7.7 score on a scale | Standard Deviation 1.4 |
| Group 2: CDOB | Modified Socket Comfort Score (Smoothness) | 7.7 score on a scale | Standard Deviation 1.9 |
| Group 2: CDOC | Modified Socket Comfort Score (Smoothness) | 7.6 score on a scale | Standard Deviation 1.8 |
| Group 3: NoCDO | Modified Socket Comfort Score (Smoothness) | 7.1 score on a scale | Standard Deviation 1.9 |
Secondary
Peak Ankle Moment
Peak ankle plantarflexion moment (Nm/kg) during gait.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| Group 1: CDOA | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| Group 1: CDOB | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| Group 1: CDOC | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.2 |
| Group 2: NoCDO | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.1 |
| Group 2: CDOA | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| Group 2: CDOB | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| Group 2: CDOC | Peak Ankle Moment | 1.5 Nm/kg | Standard Deviation 0.1 |
| Group 3: NoCDO | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.2 |
| Group 3: CDOA | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.2 |
| Group 3: CDOB | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.2 |
| Group 3: CDOC | Peak Ankle Moment | 1.4 Nm/kg | Standard Deviation 0.2 |
Secondary
Peak Ankle Power
Peak ankle push-off power (W/kg) during gait.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Ankle Power | 3.0 W/kg | Standard Deviation 0.8 |
| Group 1: CDOA | Peak Ankle Power | 1.2 W/kg | Standard Deviation 0.4 |
| Group 1: CDOB | Peak Ankle Power | 1.4 W/kg | Standard Deviation 0.5 |
| Group 1: CDOC | Peak Ankle Power | 1.6 W/kg | Standard Deviation 0.6 |
| Group 2: NoCDO | Peak Ankle Power | 2.6 W/kg | Standard Deviation 0.7 |
| Group 2: CDOA | Peak Ankle Power | 1.4 W/kg | Standard Deviation 0.2 |
| Group 2: CDOB | Peak Ankle Power | 1.2 W/kg | Standard Deviation 0.2 |
| Group 2: CDOC | Peak Ankle Power | 1.4 W/kg | Standard Deviation 0.1 |
| Group 3: NoCDO | Peak Ankle Power | 3.5 W/kg | Standard Deviation 0.6 |
| Group 3: CDOA | Peak Ankle Power | 1.5 W/kg | Standard Deviation 0.4 |
| Group 3: CDOB | Peak Ankle Power | 1.5 W/kg | Standard Deviation 0.4 |
| Group 3: CDOC | Peak Ankle Power | 1.5 W/kg | Standard Deviation 0.4 |
Secondary
Peak Gastrocnemius Muscle Force (Model Estimated)
Peak gastrocnemius muscle force (N) during gait was estimated using a participant specific musculoskeletal model.
Time frame: Baseline
Population: Peak gastrocnemius muscle force was only calculated for participants in group 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Gastrocnemius Muscle Force (Model Estimated) | 1670.3 N | Standard Deviation 328.6 |
| Group 1: CDOA | Peak Gastrocnemius Muscle Force (Model Estimated) | 1425.4 N | Standard Deviation 559.1 |
| Group 1: CDOB | Peak Gastrocnemius Muscle Force (Model Estimated) | 1568.0 N | Standard Deviation 464.3 |
| Group 1: CDOC | Peak Gastrocnemius Muscle Force (Model Estimated) | 1593.4 N | Standard Deviation 426.9 |
Secondary
Peak Soleus Muscle Force (Model Estimated)
Peak soleus muscle force (N) during gait was estimated using a participant specific musculoskeletal model.
Time frame: Baseline
Population: Peak soleus muscle force was only calculate for participants in group 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Peak Soleus Muscle Force (Model Estimated) | 2014.4 N | Standard Deviation 408.2 |
| Group 1: CDOA | Peak Soleus Muscle Force (Model Estimated) | 1344.8 N | Standard Deviation 754 |
| Group 1: CDOB | Peak Soleus Muscle Force (Model Estimated) | 1529.6 N | Standard Deviation 479.3 |
| Group 1: CDOC | Peak Soleus Muscle Force (Model Estimated) | 1534.5 N | Standard Deviation 487.5 |
Secondary
Sit to Stand 5 Times (STS5)
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to start the test sitting with their arms folded across their chest and with their back against a standard chair. Patients are then instructed to stand up and sit down 5 times as fast as possible, avoiding touching their back to the chair during each repetition. The time to complete all five continuous repetitions is reported.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | Sit to Stand 5 Times (STS5) | 7.9 seconds | Standard Deviation 2.3 |
| Group 1: CDOA | Sit to Stand 5 Times (STS5) | 8.8 seconds | Standard Deviation 2.7 |
| Group 1: CDOB | Sit to Stand 5 Times (STS5) | 8.6 seconds | Standard Deviation 2.5 |
| Group 1: CDOC | Sit to Stand 5 Times (STS5) | 8.4 seconds | Standard Deviation 2.4 |
| Group 2: NoCDO | Sit to Stand 5 Times (STS5) | 7.3 seconds | Standard Deviation 1.5 |
| Group 2: CDOA | Sit to Stand 5 Times (STS5) | 9.7 seconds | Standard Deviation 2.4 |
| Group 2: CDOB | Sit to Stand 5 Times (STS5) | 8.8 seconds | Standard Deviation 1.5 |
| Group 2: CDOC | Sit to Stand 5 Times (STS5) | 8.9 seconds | Standard Deviation 1.7 |
| Group 3: NoCDO | Sit to Stand 5 Times (STS5) | 7.0 seconds | Standard Deviation 1.3 |
| Group 3: CDOA | Sit to Stand 5 Times (STS5) | 7.5 seconds | Standard Deviation 1.5 |
| Group 3: CDOB | Sit to Stand 5 Times (STS5) | 7.7 seconds | Standard Deviation 1.8 |
| Group 3: CDOC | Sit to Stand 5 Times (STS5) | 7.8 seconds | Standard Deviation 1.6 |
Secondary
The Orthotics Prosthetics Users' Survey (OPUS)
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: NoCDO | The Orthotics Prosthetics Users' Survey (OPUS) | 29.0 score on a scale | Standard Deviation 10.9 |
| Group 1: CDOA | The Orthotics Prosthetics Users' Survey (OPUS) | 30.3 score on a scale | Standard Deviation 8.1 |
| Group 1: CDOB | The Orthotics Prosthetics Users' Survey (OPUS) | 31.7 score on a scale | Standard Deviation 9.7 |
| Group 1: CDOC | The Orthotics Prosthetics Users' Survey (OPUS) | 23.3 score on a scale | Standard Deviation 12.6 |
| Group 2: NoCDO | The Orthotics Prosthetics Users' Survey (OPUS) | 23.8 score on a scale | Standard Deviation 13.4 |
| Group 2: CDOA | The Orthotics Prosthetics Users' Survey (OPUS) | 26.0 score on a scale | Standard Deviation 14.7 |
| Group 2: CDOB | The Orthotics Prosthetics Users' Survey (OPUS) | 37.8 score on a scale | Standard Deviation 4 |
| Group 2: CDOC | The Orthotics Prosthetics Users' Survey (OPUS) | 36.3 score on a scale | Standard Deviation 3.4 |
| Group 3: NoCDO | The Orthotics Prosthetics Users' Survey (OPUS) | 36.6 score on a scale | Standard Deviation 4 |
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
Medial Gastrocnemius Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.
Time frame: Baseline
Other Pre-specified
Rectus Femoris Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Rectus Femoris 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 device options they experienced as part of the study.
Time frame: Baseline
Other Pre-specified
Soleus Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the soleus during gait.
Time frame: Baseline
Other Pre-specified
Tibialis Anterior Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of theTibialis Anterior during gait.
Time frame: Baseline
Other Pre-specified
Vastus Medialis Muscle Activity (Electromyography)
Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.
Time frame: Baseline