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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR172087 | Other Grant/Funding Number | Department of Defense |
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The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. 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.
The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NoCDO, CDOA, CDOB, CDOC | Experimental | Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. |
|
| NoCDO, CDOA, CDOC, CDOB | Experimental | Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. |
|
| NoCDO, CDOB, CDOA, CDOC | Experimental | Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. |
|
| NoCDO, CDOB, CDOC, CDOA | Experimental | Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. |
|
| NoCDO, CDOC, CDOA, CDOB | Experimental | Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon Fiber Custom Dynamic Orthosis (CDO) | Device | The CDO 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 | Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle Range of Motion | Peak dorsiflexion angle (degrees) during gait. | Baseline |
| Peak Ankle Moment | Peak ankle moment (Nm/kg) during gait. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Device Preference | 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 |
| Semi-Structured Interview |
Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| The University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NoCDO, CDOA, CDOB, CDOC | Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| FG001 | NoCDO, CDOA, CDOC, CDOB | Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| FG002 | NoCDO, CDOB, CDOA, CDOC | Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| FG003 | NoCDO, CDOB, CDOC, CDOA | Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| FG004 | NoCDO, CDOC, CDOA, CDOB | Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| FG005 | NoCDO, CDOC, CDOB, CDOA | Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No study participants were randomized to testing order NoCDO, CDOA, CDOB, CDOC
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| ID | Title | Description |
|---|---|---|
| BG000 | NoCDO, CDOA, CDOB, CDOC | Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | MPa-s/gait cycle | Baseline |
|
Study participants were asked to indicate any adverse events throughout the duration of the study visit. After completion of the study visit 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).
No study participants were randomized to testing order NoCDO, CDOA, CDOB, CDOC so no participants in that group were at risk for Serious Adverse Events, All-Cause Mortality, or Other Adverse Events
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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 | NoCDO | Participants will be evaluated without a CDO. | 0 |
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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 | Nov 7, 2023 | Dec 4, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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All participants will use three generic sized 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.
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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.
| NoCDO, CDOC, CDOB, CDOA | Experimental | Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. |
|
|
| Baseline |
| Peak Ankle Power | Peak ankle power (W/kg) during gait. | Baseline |
| Plantar Force (Total Foot) | Force data (N) collected across the total foot measured between the foot and orthosis during gait. | Baseline |
| Plantar Force (Forefoot) | Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait. | Baseline |
| Plantar Force (Midfoot) | Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait. | Baseline |
| Plantar Force (Hindfoot) | Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait. | Baseline |
| Four Square Step Test (4SST) | The 4SST (s) is a standardized timed test of balance and agility. | 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 stand up and sit down 5 times as fast as possible. | Baseline |
| Numerical Pain Rating Scale | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. | Baseline |
| The Orthotics Prosthetics Users' Survey (OPUS) | Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score. The survey asks users to indicate how much they agree with each statement on a scale from - Strongly Agree (5) to Strongly Disagree (0) with a Don't Know/Not Applicable option. The average score across all questions was calculated and reported, larger scores indicate a better outcome associated with that device. The maximum possible score is a 5 and the minimum possible score is a 0. | Baseline |
| Soleus Muscle Force (N) | Peak Soleus muscle forces (N) will be estimated using an Opensim model | Baseline |
| Gastrocnemius Muscle Force (N) | Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model | Baseline |
| Modified Socket Comfort Score (Comfort) | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. | Baseline |
| Modified Socket Comfort Score (Smoothness) | Comfort scores range from 0 = least smooth to 10 = most smooth. | Baseline |
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 | 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 |
| 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 |
| Medial Gastrocnemius Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait. | Baseline |
| Tibialis Anterior Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Tibialis Anterior during gait. | Baseline |
| NoCDO, CDOA, CDOC, CDOB |
Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| BG002 | NoCDO, CDOB, CDOA, CDOC | Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| BG003 | NoCDO, CDOB, CDOC, CDOA | Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| BG004 | NoCDO, CDOC, CDOA, CDOB | Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| BG005 | NoCDO, CDOC, CDOB, CDOA | Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants completed testing in a carbon fiber custom dynamic orthosis: CDOA, a moderate stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA)
| OG002 | CDOB | Participants completed testing in a carbon fiber custom dynamic orthosis: CDOB, a firm stiffness PhatBrace (Bio-Mechanical Composites, Des Moines, IA) |
| OG003 | CDOC | Participants completed testing in a carbon fiber custom dynamic orthosis: CDOC, the Malleo-Lok (Bio-Mechanical Composites, Des Moines, IA) |
|
|
| Secondary | Ankle Range of Motion | Peak dorsiflexion angle (degrees) during gait. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | degrees | Baseline |
|
|
|
| Secondary | Peak Ankle Moment | Peak ankle moment (Nm/kg) during gait. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | Nm/kg | Baseline |
|
|
|
| Secondary | Peak Ankle Power | Peak ankle power (W/kg) during gait. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | W/kg | Baseline |
|
|
|
| Secondary | Plantar Force (Total Foot) | Force data (N) collected across the total foot measured between the foot and orthosis during gait. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | N/kg | Baseline |
|
|
|
| Secondary | Plantar Force (Forefoot) | Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | N/kg | Baseline |
|
|
|
| Secondary | Plantar Force (Midfoot) | Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | N/kg | Baseline |
|
|
|
| Secondary | Plantar Force (Hindfoot) | Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | N/kg | Baseline |
|
|
|
| Secondary | Four Square Step Test (4SST) | The 4SST (s) is a standardized timed test of balance and agility. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
|
| 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 stand up and sit down 5 times as fast as possible. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | seconds | Baseline |
|
|
|
| Secondary | Numerical Pain Rating Scale | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | The Orthotics Prosthetics Users' Survey (OPUS) | Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score. The survey asks users to indicate how much they agree with each statement on a scale from - Strongly Agree (5) to Strongly Disagree (0) with a Don't Know/Not Applicable option. The average score across all questions was calculated and reported, larger scores indicate a better outcome associated with that device. The maximum possible score is a 5 and the minimum possible score is a 0. | The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Soleus Muscle Force (N) | Peak Soleus muscle forces (N) will be estimated using an Opensim model | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | N | Baseline |
|
|
|
| Secondary | Gastrocnemius Muscle Force (N) | Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model | Each of the study participants completed testing in all conditions: NoCDO, CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | N | Baseline |
|
|
|
| Secondary | Modified Socket Comfort Score (Comfort) | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. | The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Modified Socket Comfort Score (Smoothness) | Comfort scores range from 0 = least smooth to 10 = most smooth. | The OPUS questionnaire does not apply to none-braced conditions, as such each of the study participants completed the questionnaire in all braced conditions: CDOA, CDOB, CDOC | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Other Pre-specified | Participant Device Preference | 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. | Not Posted | Baseline | Participants |
| 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 | 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 |
| Other Pre-specified | Medial Gastrocnemius Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait. | Not Posted | Baseline | Participants |
| Other Pre-specified | Tibialis Anterior Muscle Activity (Electromyography) | Electromyography (EMG, % Maximum) of the Tibialis Anterior during gait. | Not Posted | Baseline | Participants |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | CDOA | Participants will be evaluated with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | CDOB | Participants will be evaluated with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | CDOC | Participants will be evaluated with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |