Drop Foot, Lower Limb Amputation
Conditions
Keywords
Prostheses, Orthoses
Brief summary
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).
Interventions
DEVICELower 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, 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).
DEVICEOrthoses for Drop-foot
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
Sponsors
United States Department of Defense
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Target Populations: * Participants with amputation must have used a prosthesis for more than 6 months, and wear it for at least 8 hours per day. * Participants must be more than 6 months past their most recent surgery (if any). * Participants must be free of musculoskeletal and cardiovascular conditions that would limit their ability to safely complete testing. * Participants should consider themselves in good health; be able to wear their prostheses or orthoses all day long; be able to perform all of their activities of daily living (ADL) with their prostheses or orthoses as appropriate; have a comfortably fitting functional prosthesis (if applicable) that does not cause any skin problems; and have a stable residual limb (or impaired limb). * Participants may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid but not a small-base quad cane or walker. * Participants must be able to walk with their prostheses or orthoses for 30 minutes (total) and stand for 30 minutes (total), in individual bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain or shortness of breath, or experiencing claudication symptoms. * Participants involved in running tests must be able to run for 30 minutes (total) in bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain, or experiencing claudication symptoms. * Participants must have no known cognitive disability. * Participants must be fluent in spoken and written English. * Running portions of the study will be limited to participants who self-report regular engagement in recreational or competitive running. * Participants in the branch that uses only their own prostheses must have at least a daily use prosthesis and a running-specific prosthesis; additional prostheses may also be included Multiple Sclerosis group: * For the specific subgroup targeting Multiple Sclerosis, participants must have a clinical diagnosis of Multiple Sclerosis and a clinician must determine they are experiencing foot drop. * Participants must be able to comfortably wear and ambulate with both study devices with effective management of foot-drop, without significant discomfort * Participants must be able to perform all of their activities of daily living (ADL) with only minimal use of ambulatory aids. Subjects may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid in any amount. Use of more comprehensive ambulatory aids (e.g. a small-base quad cane, wide-base quad cane or walker) must be limited to no more than 20% of their walking time when not at home. Participants who do use an assistive device occasionally should report a threshold for use of greater than 100 feet, i.e., they are unlikely to use their device unless they anticipate ambulating greater than this distance.
Exclusion criteria
Target Populations: * Allergy to electrode gel, surgical tape and metals. * Participants who currently use the Bioness L300 Go or similar neuro-orthoses or use a carbon fiber ankle-foot orthosis at the time of the study will be excluded to avoid biasing results for one device or the other. Participants with past experience not currently using these devices will be eligible. * Participants enrolled in physical therapy or other rehabilitative care for treatment of gait, balance, or lower extremity strength or coordination at the time of the study will be excluded to avoid confounding effects from therapy and device-based management of their condition. * For the orthotics study, participants with peripheral neuropathy impacting control of the tibialis anterior muscle via the peroneal nerve will be excluded. * Participants under treatment for infectious diseases will be excluded from the study. * Women who are pregnant or planning to become pregnant during the course of the study will be excluded. * Symptomatic musculoskeletal conditions that prevent unaided walking, such as back pain or knee arthritis. * Cardiovascular conditions that make moderate exercise unsafe, including (but not limited to) history of angina, peripheral vascular disease, congestive heart failure, history of myocardial infarction, and history of stroke. Potential participants will be excluded if they self-report that a physician has told them to avoid moderate exercise. * History of chest pain, shortness of breath, or claudication symptoms during ambulation * History of significant neuropathy with altered balance * History of serious residual limb pain or phantom limb pain within the past six months. * History of chronic skin breakdown. * Inability to perform the tasks involved in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Foot Clearance With Different Prostheses | 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 prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. |
| Minimum Foot Clearance With Different Orthoses | Baseline, 10 days, and 20 days for Orthotic interventions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Limb Users Survey of Mobility Score | up to 12 weeks | 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. |
| Change in Movement Quality as Determined by Stride Width: Prosthesis | 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 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. |
| Change in Movement Quality as Determined by Stride Width: Orthoses | Baseline, 10 days, and 20 days for Orthotic interventions | 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. |
| Change in Gait Performance as Determined by Average Speed | 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 speed of the participant, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. |
| Gait Performance as Determined by Stride Frequency at Identical Speed | 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 (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. |
| Behavioral Gait Function as Measured From Daily Stride Count | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study | 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. |
| Change in Gait Performance as Determined by Socket Torques | 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 | 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. |
| Change in Functional Gait Assessment Score | Baseline, 10 days, and 20 days for Orthotic interventions | 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. |
| Change in 6 Minute Walking Test Distance | Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions | 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. |
| Stride Length at Identical Walking Speed | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study | 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. |
| Change in Gait Performance as Determined by Ground Reaction Forces | 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 | 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. |
| Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study | 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. |
Countries
United States
Participant flow
Pre-assignment details
Healthy control participants were not consented or enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 6 |
| 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. | 11 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Prosthesis User With Transtibial or Transfemoral Amputation | Orthoses User With Drop-foot | Total |
|---|---|---|---|
| Age, Continuous | 57 years | 43 years | 48 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 17 Participants |
| Participants Diagnosed with Multiple Sclerosis (MS) | 0 Participants | 11 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 17 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 6 participants | 11 participants | 17 participants |
| Sex: Female, Male Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 11 |
| other Total, other adverse events | 0 / 6 | 0 / 11 |
| serious Total, serious adverse events | 0 / 6 | 0 / 11 |
Outcome results
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.
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions
Population: 1 participant could not be assessed for this measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Minimum Foot Clearance With Different Orthoses | No Intervention | 0.56469 centimeters | Standard Deviation 0.662561 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Minimum Foot Clearance With Different Orthoses | Ankle Foot Orthosis | 0.721081 centimeters | Standard Deviation 0.857378 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Minimum Foot Clearance With Different Orthoses | Functional Electrical Stimulation Device | 0.81136 centimeters | Standard Deviation 1.105746 |
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.
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Population: All participants did not complete tests with all prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Minimum Foot Clearance With Different Prostheses | Low Profile Foot | 0.02117 meters | Standard Deviation 0.005247 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Minimum Foot Clearance With Different Prostheses | Energy Storage and Return Foot | 0.01976 meters | Standard Deviation 0.007828 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Minimum Foot Clearance With Different Prostheses | Microprocessor Hydraulic Ankle | 0.03055 meters | Standard Deviation 0.00136 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Minimum Foot Clearance With Different Prostheses | Passive Hydraulic Ankle | 0.01932 meters | Standard Deviation 0.004138 |
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.
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Population: All participants did not complete tests with all prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Daily Stride Count | Low Profile Foot | 264.9 strides per sensor hour | Standard Deviation 177 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Daily Stride Count | Energy Storage and Return Foot | 245.7 strides per sensor hour | Standard Deviation 113.1 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Daily Stride Count | Passive Hydraulic Ankle | 230.9 strides per sensor hour | Standard Deviation 117.8 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Daily Stride Count | Microprocessor Hydraulic Ankle | 269.3 strides per sensor hour | Standard Deviation 92.49 |
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.
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Population: Participants had varying ability to walk at different speeds.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | less than 10 seconds | 0.4685 meters per second | Standard Deviation 0.049 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | 10 to 30 seconds | 0.7155 meters per second | Standard Deviation 0.0936 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | 30-60 seconds | 0.906 meters per second | Standard Deviation 0.1172 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | 60-120 seconds | 0.9652 meters per second | Standard Deviation 0.1562 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations | greater than 120 seconds | 1.0486 meters per second | Standard Deviation 0.1979 |
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.
Time frame: Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in 6 Minute Walking Test Distance | No Intervention | 394.94 meters | Standard Deviation 123.83 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in 6 Minute Walking Test Distance | AFO: Sprystep | 426.73 meters | Standard Deviation 117.87 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in 6 Minute Walking Test Distance | FES: Bioness | 419.09 meters | Standard Deviation 127.16 |
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.
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Functional Gait Assessment Score | No Intervention | 16.09 score on a scale | Standard Deviation 5.23 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Functional Gait Assessment Score | Ankle Foot Orthosis | 17.27 score on a scale | Standard Deviation 6.566 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Functional Gait Assessment Score | Functional Electrical Stimulation Device | 18.45 score on a scale | Standard Deviation 5.298 |
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.
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Population: All participants did not complete tests with all prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Gait Performance as Determined by Average Speed | Low Profile Foot | 0.8376 meter per second | Standard Deviation 0.1332 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Gait Performance as Determined by Average Speed | Energy Storage and Return Foot | 0.8553 meter per second | Standard Deviation 0.1149 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Gait Performance as Determined by Average Speed | Passive Hydraulic Ankle | 0.8635 meter per second | Standard Deviation 0.1444 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Gait Performance as Determined by Average Speed | Microprocessor Hydraulic Ankle | 0.9521 meter per second | Standard Deviation 0.08561 |
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.
Time frame: 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
Population: No data was collected because the force and torque sensor could not be fit into the leg.
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.
Time frame: 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
Population: No data collected because the force and torque sensor could not be fit into the leg.
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.
Time frame: Baseline, 10 days, and 20 days for Orthotic interventions
Population: Sensor did not work for one participant during the AFO condition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Movement Quality as Determined by Stride Width: Orthoses | No Intervention | 0.045 meters | Standard Deviation 0.01 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Movement Quality as Determined by Stride Width: Orthoses | AFO: Sprystep | 0.045 meters | Standard Deviation 0.01 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Movement Quality as Determined by Stride Width: Orthoses | FES: Bioness | 0.047 meters | Standard Deviation 0.014 |
Comparison: No Intervention vs AFOp-value: 0.649t-test, 2 sided
Comparison: No Intervention vs FESp-value: 0.513t-test, 2 sided
Comparison: AFO vs FESp-value: 0.617t-test, 2 sided
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.
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Population: All participants did not complete tests with all prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Movement Quality as Determined by Stride Width: Prosthesis | Low Profile Foot | 0.1328 meters | Standard Deviation 0.03138 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Movement Quality as Determined by Stride Width: Prosthesis | Energy Storage and Return Foot | 0.1417 meters | Standard Deviation 0.05243 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Movement Quality as Determined by Stride Width: Prosthesis | Passive Hydraulic Ankle | 0.11526455 meters | Standard Deviation 0.02398894 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Change in Movement Quality as Determined by Stride Width: Prosthesis | Microprocessor Hydraulic Ankle | 0.1202 meters | Standard Deviation 0.0451 |
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.
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Population: All participants did not complete tests with all prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Gait Performance as Determined by Stride Frequency at Identical Speed | Low Profile Foot | 67.47 strides per minute | Standard Deviation 3.237 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Gait Performance as Determined by Stride Frequency at Identical Speed | Energy Storage and Return Foot | 68.22 strides per minute | Standard Deviation 5.835 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Gait Performance as Determined by Stride Frequency at Identical Speed | Passive Hydraulic Ankle | 67.46 strides per minute | Standard Deviation 4.13 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Gait Performance as Determined by Stride Frequency at Identical Speed | Microprocessor Hydraulic Ankle | 60.37 strides per minute | Standard Deviation 5.448 |
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.
Time frame: up to 12 weeks
Population: All participants did not complete tests with all prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Prosthetic Limb Users Survey of Mobility Score | Low Profile Foot | 56.5 T-score | Standard Deviation 7.665246245 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Prosthetic Limb Users Survey of Mobility Score | Energy Storage and Return Foot | 53.78 T-score | Standard Deviation 7.3123 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Prosthetic Limb Users Survey of Mobility Score | Passive Hydraulic Ankle | 53.83 T-score | Standard Deviation 7.898 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Prosthetic Limb Users Survey of Mobility Score | Microprocessor Hydraulic Ankle | 47.4 T-score | Standard Deviation 5.444 |
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.
Time frame: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study
Population: All participants did not complete tests with all prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prosthesis User With Transtibial or Transfemoral Amputation | Stride Length at Identical Walking Speed | Low Profile Foot | 1.196 meters | Standard Deviation 0.1434 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Stride Length at Identical Walking Speed | Energy Storage and Return Foot | 1.198 meters | Standard Deviation 0.09409 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Stride Length at Identical Walking Speed | Passive Hydraulic Ankle | 1.200 meters | Standard Deviation 0.1564 |
| Prosthesis User With Transtibial or Transfemoral Amputation | Stride Length at Identical Walking Speed | Microprocessor Hydraulic Ankle | 1.302 meters | Standard Deviation 0.1194 |