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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR172087 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| University of Delaware | OTHER |
| Bio-Mechanical Composites | UNKNOWN |
| Fabtech Systems | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Device | No Intervention | Participants will be evaluated without a CDO. | |
| CDO-A | Experimental | The first design variant will be designated CDO-A |
|
| CDO-B | Experimental | The second design variant will be designated CDO-B |
|
| CDO-C | Experimental | The third design variant will be designated CDO-C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom Carbon Fiber Dynamic Orthosis (CDO) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Soleus Muscle Force (Model Estimated) | Peak soleus muscle force (N) during gait was estimated using a participant specific musculoskeletal model. | Baseline |
| Peak Gastrocnemius Muscle Force (Model Estimated) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Center of Pressure Velocity Timing |
TIBIAL PILON FRACTURE PARTICIPANTS:
Inclusion Criteria:
Exclusion Criteria:
HEALTHY ABLE-BODIED PARTICIPANTS:
Patient Inclusion Criteria
Patient Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jason M Wilken, PT, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| FG005 | 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 |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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. |
| FG011 | 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. |
| FG012 | 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. |
| FG013 | 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. |
| FG014 | 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. |
| FG015 | 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. |
| FG016 | 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. |
| FG017 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Some randomization options (ex. Group 1: NoCDO, CDOB, CDOC, CDOA) had no participants assigned to them, resulting in an overall number of baseline participants equaling zero.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Peak joint contact stress time exposure was only calculated for participants in group 1. | Posted | Mean | Standard Deviation | MPa-s/gait cycle | Baseline |
|
Study participants were asked to indicate any adverse events throughout the duration of each study visit. After completion of the study participants were also asked to call or email the research team if any adverse events related to the study occurred after the study visit (up to ~12 months after the visit).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: NoCDO | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason M. Wilken, PT, PhD | The University of Iowa | 319-335-6857 | jason-wilken@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2024 | Jun 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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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.
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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.
|
| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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 | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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). | Baseline |
| 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). | Baseline |
| 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). | Baseline |
Peak gastrocnemius muscle force (N) during gait was estimated using a participant specific musculoskeletal model.
| Baseline |
| Ankle Range of Motion | Peak ankle dorsiflexion (degrees) during gait. | Baseline |
| Peak Ankle Moment | Peak ankle plantarflexion moment (Nm/kg) during gait. | Baseline |
| Peak Ankle Power | Peak ankle push-off power (W/kg) during gait. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
Timing of peak center of pressure velocity (percent stance) during gait. |
| Baseline |
| Center of Pressure Velocity Magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | Baseline |
| Soleus Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the soleus during gait. | Baseline |
| Tibialis Anterior Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of theTibialis Anterior during gait. | Baseline |
| Medial Gastrocnemius Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait. | Baseline |
| Rectus Femoris Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Rectus Femoris during gait. | Baseline |
| Vastus Medialis Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Vastus Medialis during gait. | Baseline |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | 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. |
| BG009 | 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. |
| BG010 | 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. |
| BG011 | 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. |
| BG012 | 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. |
| BG013 | 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. |
| BG014 | 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. |
| BG015 | 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. |
| BG016 | 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. |
| BG017 | 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. |
| BG018 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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 |
| OG002 | Group 1: CDOB | 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 |
| OG003 | Group 1: CDOC | 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 |
| OG004 | Group 2: NoCDO | 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. |
| OG005 | Group 2: CDOA | 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. |
| OG006 | Group 2: CDOB | 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. |
| OG007 | Group 2: CDOC | 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. |
| OG008 | Group 3: NoCDO | 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. |
| OG009 | Group 3: CDOA | 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. |
| OG010 | Group 3: CDOB | 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. |
| OG011 | Group 3: CDOC | 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. |
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| 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. | Posted | Mean | Standard Deviation | N/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | N/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | N/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | N/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | Ns/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | Ns/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | Ns/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | Ns/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | Posted | Count of Participants | Participants | Baseline |
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| 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. | Posted | Count of Participants | Participants | Baseline |
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| 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). | Posted | Count of Participants | Participants | Baseline |
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| 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). | Posted | Count of Participants | Participants | Baseline |
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| 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). | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Peak Soleus Muscle Force (Model Estimated) | Peak soleus muscle force (N) during gait was estimated using a participant specific musculoskeletal model. | Peak soleus muscle force was only calculate for participants in group 1. | Posted | Mean | Standard Deviation | N | Baseline |
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| Secondary | Peak Gastrocnemius Muscle Force (Model Estimated) | Peak gastrocnemius muscle force (N) during gait was estimated using a participant specific musculoskeletal model. | Peak gastrocnemius muscle force was only calculated for participants in group 1. | Posted | Mean | Standard Deviation | N | Baseline |
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| Secondary | Ankle Range of Motion | Peak ankle dorsiflexion (degrees) during gait. | Posted | Mean | Standard Deviation | degree | Baseline |
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| Secondary | Peak Ankle Moment | Peak ankle plantarflexion moment (Nm/kg) during gait. | Posted | Mean | Standard Deviation | Nm/kg | Baseline |
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| Secondary | Peak Ankle Power | Peak ankle push-off power (W/kg) during gait. | Posted | Mean | Standard Deviation | W/kg | Baseline |
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| 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. | Posted | Mean | Standard Deviation | seconds | Baseline |
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| 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. | Posted | Mean | Standard Deviation | seconds | Baseline |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 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. | Not Posted | Baseline | Participants |
| Other Pre-specified | Center of Pressure Velocity Timing | Timing of peak center of pressure velocity (percent stance) during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Center of Pressure Velocity Magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Soleus Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the soleus during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Tibialis Anterior Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of theTibialis Anterior during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Medial Gastrocnemius Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Rectus Femoris Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Rectus Femoris during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Vastus Medialis Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Vastus Medialis during gait. | Not Posted | Baseline | Participants |
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Group 1: CDOA | 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 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Group 1: CDOB | 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 | 7 | 0 | 7 | 0 | 7 |
| EG003 | Group 1: CDOC | 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 | 7 | 0 | 7 | 0 | 7 |
| EG004 | Group 2: NoCDO | 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 | 6 | 0 | 6 | 0 | 6 |
| EG005 | Group 2: CDOA | 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 | 6 | 0 | 6 | 0 | 6 |
| EG006 | Group 2: CDOB | 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 | 6 | 0 | 6 | 0 | 6 |
| EG007 | Group 2: CDOC | 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 | 6 | 0 | 6 | 0 | 6 |
| EG008 | Group 3: NoCDO | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG009 | Group 3: CDOA | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG010 | Group 3: CDOB | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG011 | Group 3: CDOC | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided
| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |