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| ID | Type | Description | Link |
|---|---|---|---|
| A196200 | Other Identifier | UW Madison | |
| ENGR/MECHANICAL ENGR/MECH ENGR | Other Identifier | UW Madison | |
| BA180043 | Other Grant/Funding Number | US Department of Defense | |
| Protocol Version 9/21/2023 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigators seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigators seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study.
Participants with lower-limb amputation, participants who use lower limb orthoses, and participants with drop-foot (including a specific group with Multiple Sclerosis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prosthesis user with transtibial or transfemoral amputation | Experimental | Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). |
|
| Orthoses user with drop-foot | Experimental | This arm will consists of participants with drop-foot. A subset of the drop-foot population will be persons with Multiple Sclerosis and currently drop-foot. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower limb prostheses | Device | Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR, Agilix) feet and low-profile foot (LP, Pacifica LP), ESR feet with mobilized ankles such as passive hydraulic ankles (PHA, Kinterra), and ESR feet with microprocessor-controlled ankles (MPA, Kinnex). |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Foot Clearance With Different Prostheses | Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| Minimum Foot Clearance With Different Orthoses | Minimum Foot Clearance with different orthoses, participants crossover to each of 3 different conditions at different study visits, data collected up to 20 days on study. | Baseline, 10 days, and 20 days for Orthotic interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral Gait Function as Measured From Daily Stride Count | Behavioral gait function will be measured by daily stride count (strides per sensor hour, Prosthetics only), participants crossed over to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
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Inclusion Criteria:
Target Populations:
Multiple Sclerosis group:
Exclusion Criteria:
Target Populations:
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| Name | Affiliation | Role |
|---|---|---|
| Peter G Adamczyk, Ph.D. | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53706-1539 | United States |
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Healthy control participants were not consented or enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prosthesis User With Transtibial or Transfemoral Amputation | Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). |
| FG001 | Orthoses User With Drop-foot | This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prosthesis User With Transtibial or Transfemoral Amputation | Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). |
| 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 | Minimum Foot Clearance With Different Prostheses | Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | All participants did not complete tests with all prostheses. | Posted | Mean | Standard Deviation | meters | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
participants were on study up to 12 weeks
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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 | Prosthesis User With Transtibial or Transfemoral Amputation | Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Adamczyk | University of Wisconsin - Madison | (608) 263-3231 | peter.adamczyk@wisc.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 | Sep 21, 2023 | Jul 24, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 2, 2023 | Dec 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020427 | Peroneal Neuropathies |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001186 | Artificial Limbs |
| D009989 | Orthotic Devices |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
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Participants will perform testing inside the laboratory ("lab testing"), outside the laboratory ("field testing") on the campus of University of Wisconsin, Madison, and/or extended testing in a home and community environment ("take-home testing") to evaluate different aspects of device function.
Outcomes will generally be compared using a repeated-measures design, in which each participant acts as his/her own control. This design is chosen to minimize the statistical problems caused by heterogeneity in the participant population.
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|
|
| Orthoses for Drop-foot | Device | Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses. Sprystep for the caAFO, Bioness L300 Go for the FES |
|
|
| Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | Behavioral gait function will be measured by average stride speed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| Prosthetic Limb Users Survey of Mobility Score | The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a 12 item questionnaire. It is a self-report instrument for measuring mobility of adults with lower limb amputation. PLUS-M instruments measure prosthetic users' mobility (i.e., the ability to move intentionally and independently from one place to another). PLUS-M questions assess respondents' perceived ability to carry out actions that require use of both lower limbs, ranging from household ambulation to outdoor recreational activities. The described activities relate to two primary forms of movement, locomotion (i.e., movement in a continuous, repeatable pattern) and/or postural transitions (i.e., movement from one position to another or one type of activity to another). PLUS-M instruments provide a T-score that averages 50 with a standard deviation of 10. A higher PLUS-M T-score corresponds to greater mobility. | up to 12 weeks |
| Change in Movement Quality as Determined by Stride Width: Prosthesis | Change in movement quality will be determined by stride width, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride. | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| Change in Movement Quality as Determined by Stride Width: Orthoses | Change in movement quality will be determined by stride width, participants crossover to different conditions at different study visits, data collected up to 20 days on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride. | Baseline, 10 days, and 20 days for Orthotic interventions |
| Change in Gait Performance as Determined by Average Speed | Change in gait performance as determined by speed of the participant, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| Gait Performance as Determined by Stride Frequency at Identical Speed | Gait performance as determined by stride frequency at identical speed (included strides with walking speeds between 0.75-1.25 meters per second). Participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| Change in Gait Performance as Determined by Ground Reaction Forces | Ground reaction force is force applied by the body to the ground. Peak forces and shape of the force vs. time trajectory are commonly used to assess gait quality. Forces closer to "normal" are usually considered better, but this goal does not apply in participants with amputation. | Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| Change in Gait Performance as Determined by Socket Torques | Socket torque (also termed "socket moment") is the amount of twisting or bending torque applied to the prosthetic socket. Peak socket torque and cumulative socket torque are measures commonly used to assess gait quality in persons with lower limb amputation. | Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| Change in Functional Gait Assessment Score | The Functional Gait Assessment Score will be measured for the sub-population of participants with Multiple Sclerosis (MS). The total score ranges from 0-30 with higher scores indicating increased impairment in gait. Participants crossover to each of three conditions at different study visits. | Baseline, 10 days, and 20 days for Orthotic interventions |
| Change in 6 Minute Walking Test Distance | The sub-population of participants with MS will undergo a 6 minute walking test for distance. Each participant will crossover to three conditions over three study visits: No intervention, the carbon fiber ankle foot orthosis (cfAFO), and a functional electrical stimulation (FES) device). Reported here are the difference from No intervention for the cfAFO and FES orthoses, a positive number shows an increase in distance walked due to the intervention. | Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions |
| Stride Length at Identical Walking Speed | Walking speeds from 0.75 to 1.25 meters per second were analyzed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
| BG001 | Orthoses User With Drop-foot | This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses. |
| BG002 | 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 |
|
| Region of Enrollment | Number | participants |
|
| Participants Diagnosed with Multiple Sclerosis (MS) | Count of Participants | Participants |
|
|
|
| Primary | Minimum Foot Clearance With Different Orthoses | Minimum Foot Clearance with different orthoses, participants crossover to each of 3 different conditions at different study visits, data collected up to 20 days on study. | 1 participant could not be assessed for this measure | Posted | Mean | Standard Deviation | centimeters | Baseline, 10 days, and 20 days for Orthotic interventions |
|
|
|
| Secondary | Behavioral Gait Function as Measured From Daily Stride Count | Behavioral gait function will be measured by daily stride count (strides per sensor hour, Prosthetics only), participants crossed over to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | All participants did not complete tests with all prostheses. | Posted | Mean | Standard Deviation | strides per sensor hour | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
|
| Secondary | Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | Behavioral gait function will be measured by average stride speed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | Participants had varying ability to walk at different speeds. | Posted | Mean | Standard Deviation | meters per second | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
|
| Secondary | Prosthetic Limb Users Survey of Mobility Score | The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a 12 item questionnaire. It is a self-report instrument for measuring mobility of adults with lower limb amputation. PLUS-M instruments measure prosthetic users' mobility (i.e., the ability to move intentionally and independently from one place to another). PLUS-M questions assess respondents' perceived ability to carry out actions that require use of both lower limbs, ranging from household ambulation to outdoor recreational activities. The described activities relate to two primary forms of movement, locomotion (i.e., movement in a continuous, repeatable pattern) and/or postural transitions (i.e., movement from one position to another or one type of activity to another). PLUS-M instruments provide a T-score that averages 50 with a standard deviation of 10. A higher PLUS-M T-score corresponds to greater mobility. | All participants did not complete tests with all prostheses. | Posted | Mean | Standard Deviation | T-score | up to 12 weeks |
|
|
|
| Secondary | Change in Movement Quality as Determined by Stride Width: Prosthesis | Change in movement quality will be determined by stride width, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride. | All participants did not complete tests with all prostheses. | Posted | Mean | Standard Deviation | meters | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
|
| Secondary | Change in Movement Quality as Determined by Stride Width: Orthoses | Change in movement quality will be determined by stride width, participants crossover to different conditions at different study visits, data collected up to 20 days on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride. | Sensor did not work for one participant during the AFO condition. | Posted | Mean | Standard Deviation | meters | Baseline, 10 days, and 20 days for Orthotic interventions |
|
|
|
|
| Secondary | Change in Gait Performance as Determined by Average Speed | Change in gait performance as determined by speed of the participant, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | All participants did not complete tests with all prostheses. | Posted | Mean | Standard Deviation | meter per second | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
|
| Secondary | Gait Performance as Determined by Stride Frequency at Identical Speed | Gait performance as determined by stride frequency at identical speed (included strides with walking speeds between 0.75-1.25 meters per second). Participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | All participants did not complete tests with all prostheses. | Posted | Mean | Standard Deviation | strides per minute | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
|
| Secondary | Change in Gait Performance as Determined by Ground Reaction Forces | Ground reaction force is force applied by the body to the ground. Peak forces and shape of the force vs. time trajectory are commonly used to assess gait quality. Forces closer to "normal" are usually considered better, but this goal does not apply in participants with amputation. | No data was collected because the force and torque sensor could not be fit into the leg. | Posted | Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
| Secondary | Change in Gait Performance as Determined by Socket Torques | Socket torque (also termed "socket moment") is the amount of twisting or bending torque applied to the prosthetic socket. Peak socket torque and cumulative socket torque are measures commonly used to assess gait quality in persons with lower limb amputation. | No data collected because the force and torque sensor could not be fit into the leg. | Posted | Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
| Secondary | Change in Functional Gait Assessment Score | The Functional Gait Assessment Score will be measured for the sub-population of participants with Multiple Sclerosis (MS). The total score ranges from 0-30 with higher scores indicating increased impairment in gait. Participants crossover to each of three conditions at different study visits. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 10 days, and 20 days for Orthotic interventions |
|
|
|
| Secondary | Change in 6 Minute Walking Test Distance | The sub-population of participants with MS will undergo a 6 minute walking test for distance. Each participant will crossover to three conditions over three study visits: No intervention, the carbon fiber ankle foot orthosis (cfAFO), and a functional electrical stimulation (FES) device). Reported here are the difference from No intervention for the cfAFO and FES orthoses, a positive number shows an increase in distance walked due to the intervention. | Posted | Mean | Standard Deviation | meters | Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions |
|
|
|
| Secondary | Stride Length at Identical Walking Speed | Walking speeds from 0.75 to 1.25 meters per second were analyzed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. | All participants did not complete tests with all prostheses. | Posted | Mean | Standard Deviation | meters | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Orthoses User With Drop-foot | This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D009983 |
| Orthopedic Equipment |
| Title | Measurements |
|---|---|
|
|
| Passive Hydraulic Ankle |
|
|
| Microprocessor Hydraulic Ankle |
|
|
|
| 30-60 seconds |
|
|
| 60-120 seconds |
|
|
| greater than 120 seconds |
|
|
|
| Passive Hydraulic Ankle |
|
|
| Microprocessor Hydraulic Ankle |
|
|
|
| Passive Hydraulic Ankle |
|
|
| Microprocessor Hydraulic Ankle |
|
|
|
| FES: Bioness |
|
|
| Superiority |
| AFO vs FES | t-test, 2 sided | 0.617 | Superiority |
|
| Passive Hydraulic Ankle |
|
|
| Microprocessor Hydraulic Ankle |
|
|
|
| Passive Hydraulic Ankle |
|
|
| Microprocessor Hydraulic Ankle |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Passive Hydraulic Ankle |
|
|
| Microprocessor Hydraulic Ankle |
|
|