Amputation, Traumatic, Unilateral Traumatic Amputation
Conditions
Keywords
powered ankle prosthesis, activity monitoring, muscle fatigue, below knee amputation
Brief summary
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
Detailed description
Many individuals are living in the United States with limb loss. With the use of a prosthetic device many individuals can stay active, but most do not achieve a medically desired physical activity level. This creates a risk for cardiovascular disease. It is thought that individuals with amputation walk less because it is more difficult to get around, and recent advances in robotic prosthetic technology may make such activities easier. However, these prostheses have not yet been evaluated to determine their effectiveness during extended periods of walking. Despite the goals in design of new devices it is unclear whether individuals using them are able to incorporate them into making daily activities easier. Therefore, the goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during long periods of walking.
Interventions
DEVICEPowered ankle prosthesis
This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.
DEVICEDynamic Response Foot
This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.
Sponsors
Deanna H Gates
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes
Exclusion criteria
* History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Cost of Walking | Testing took place after wearing the prostheses for two weeks | Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed. |
| Total Steps Outside the Home Over a Two Week Period | 2 weeks | Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period. Daily step count taken outside of the home, determined using an activity monitor and GPS device |
| Quality of Life (QoL) on a Short-Form 36 | Questionnaire completed 2 weeks after wearing each prosthesis | Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Evaluation Questionnaire (PEQ) | Questionnaire completed 2 weeks after wearing each prosthesis | Participants completed a survey to evaluate their prosthetic satisfaction (Prosthetic Evaluation Questionnaire) after each condition. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line (0 mm) to the point at which the respondent's mark crosses the line (up to 100 mm). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Ambulation - Greater number = increased perceived ambulation Appearance - Greater number = better appearance Frustration - Greater number = less frustration Perceived Response - Greater number = increased perceived response Residual Limb Health - Greater number = better residual limb health Social burden - Greater number = less social burden Sounds - Greater number = less sound Utility - Greater |
| Muscle Activity in the Lower Limb | Testing took place after the participant wore the prosthesis for 2 weeks | Participants walk on a treadmill while muscle activity from various lower limb muscles are monitored using electromyography. We calculated the integrated EMG (iEMG) for each muscle collected as the total activity in that muscle as a percentage of the maximum signal. |
| Time to Fatigue | Testing took place after wearing the prostheses for two weeks | Participants walk on a treadmill at a fast speed until they felt they can no longer continue. The time to fatigue was recorded. |
Countries
United States
Participant flow
Recruitment details
Recruitment began after initial approval from the University of Michigan IRB (July 2016). Participants were recruited through the University of Michigan Orthotics and Prosthetics Clinic by a study physician and study prosthetist in-person, through phone or email, or with flyers.
Pre-assignment details
Participants were asked to complete both arms of the study. Before starting, participants were randomly enrolled in the dynamic response foot (unpowered prosthesis) or powered condition to start with. Some participants completed both arms while others only finished one of the arms.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This group represents all participants enrolled in the study. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (3 Weeks) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 50.27 years STANDARD_DEVIATION 13.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Metabolic Cost of Walking
Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.
Time frame: Testing took place after wearing the prostheses for two weeks
Population: Each participant wore both study prostheses. One participant was excluded from analysis as he was not able to reach steady-state energetics on a treadmill
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unpowered Prosthesis | Metabolic Cost of Walking | 0.409 J/Nm | Standard Deviation 0.04 |
| BiOM Powered Prosthesis | Metabolic Cost of Walking | 0.397 J/Nm | Standard Deviation 0.078 |
Comparison: The null hypothesis was that there would be no difference in metabolic costs between the two groupsp-value: 0.585t-test, 2 sided
Primary
Quality of Life (QoL) on a Short-Form 36
Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Questionnaire completed 2 weeks after wearing each prosthesis
Population: Each participant in the study wore both prostheses
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unpowered Prosthesis | Quality of Life (QoL) on a Short-Form 36 | Physical Component Score | 62.9 scores on a scale | Standard Deviation 17.5 |
| Unpowered Prosthesis | Quality of Life (QoL) on a Short-Form 36 | Mental Component Score | 63.6 scores on a scale | Standard Deviation 19.1 |
| BiOM Powered Prosthesis | Quality of Life (QoL) on a Short-Form 36 | Physical Component Score | 59.4 scores on a scale | Standard Deviation 22 |
| BiOM Powered Prosthesis | Quality of Life (QoL) on a Short-Form 36 | Mental Component Score | 67.4 scores on a scale | Standard Deviation 24 |
p-value: 0.48t-test, 2 sided
Comparison: Mental Component Scorep-value: 0.408t-test, 2 sided
Primary
Total Steps Outside the Home Over a Two Week Period
Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period. Daily step count taken outside of the home, determined using an activity monitor and GPS device
Time frame: 2 weeks
Population: Each participant in the study wore both prostheses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unpowered Prosthesis | Total Steps Outside the Home Over a Two Week Period | 2030 steps | Standard Deviation 1440 |
| BiOM Powered Prosthesis | Total Steps Outside the Home Over a Two Week Period | 1640 steps | Standard Deviation 1100 |
Comparison: The null hypothesis was that there were no differences in the number of steps taken outside of the home for the two prostheses.p-value: 0.452t-test, 2 sided
Secondary
Muscle Activity in the Lower Limb
Participants walk on a treadmill while muscle activity from various lower limb muscles are monitored using electromyography. We calculated the integrated EMG (iEMG) for each muscle collected as the total activity in that muscle as a percentage of the maximum signal.
Time frame: Testing took place after the participant wore the prosthesis for 2 weeks
Population: Each participant wore both study prostheses
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unpowered Prosthesis | Muscle Activity in the Lower Limb | Intact side rectus femoris | 25.3 percentage of maximum signal | Standard Deviation 4.06 |
| Unpowered Prosthesis | Muscle Activity in the Lower Limb | Intact side tibialis anterior | 28.4 percentage of maximum signal | Standard Deviation 10.2 |
| Unpowered Prosthesis | Muscle Activity in the Lower Limb | Intact side biceps femoris | 24.3 percentage of maximum signal | Standard Deviation 5.07 |
| Unpowered Prosthesis | Muscle Activity in the Lower Limb | Residual side biceps femoris | 27.8 percentage of maximum signal | Standard Deviation 10.8 |
| Unpowered Prosthesis | Muscle Activity in the Lower Limb | Intact side soleus | 29.9 percentage of maximum signal | Standard Deviation 6.47 |
| Unpowered Prosthesis | Muscle Activity in the Lower Limb | Residual side rectus femoris | 38.3 percentage of maximum signal | Standard Deviation 12.2 |
| BiOM Powered Prosthesis | Muscle Activity in the Lower Limb | Residual side rectus femoris | 41.3 percentage of maximum signal | Standard Deviation 9.01 |
| BiOM Powered Prosthesis | Muscle Activity in the Lower Limb | Intact side biceps femoris | 24.1 percentage of maximum signal | Standard Deviation 8.83 |
| BiOM Powered Prosthesis | Muscle Activity in the Lower Limb | Intact side rectus femoris | 28.7 percentage of maximum signal | Standard Deviation 14.1 |
| BiOM Powered Prosthesis | Muscle Activity in the Lower Limb | Intact side soleus | 28.6 percentage of maximum signal | Standard Deviation 9.11 |
| BiOM Powered Prosthesis | Muscle Activity in the Lower Limb | Intact side tibialis anterior | 30.4 percentage of maximum signal | Standard Deviation 7.99 |
| BiOM Powered Prosthesis | Muscle Activity in the Lower Limb | Residual side biceps femoris | 25.9 percentage of maximum signal | Standard Deviation 8.7 |
Comparison: Intact Side Soleusp-value: 0.844t-test, 2 sided
Comparison: Intact Side Biceps Femorisp-value: 0.655t-test, 2 sided
Comparison: Intact Side Rectus Femorisp-value: 0.281t-test, 2 sided
Comparison: Intact Side Tibialis Anteriorp-value: 0.11t-test, 2 sided
Comparison: Residual Side Biceps Femorisp-value: 0.394t-test, 2 sided
Comparison: Residual Side Rectus Femorisp-value: 0.141t-test, 2 sided
Secondary
Prosthetic Evaluation Questionnaire (PEQ)
Participants completed a survey to evaluate their prosthetic satisfaction (Prosthetic Evaluation Questionnaire) after each condition. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line (0 mm) to the point at which the respondent's mark crosses the line (up to 100 mm). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Ambulation - Greater number = increased perceived ambulation Appearance - Greater number = better appearance Frustration - Greater number = less frustration Perceived Response - Greater number = increased perceived response Residual Limb Health - Greater number = better residual limb health Social burden - Greater number = less social burden Sounds - Greater number = less sound Utility - Greater
Time frame: Questionnaire completed 2 weeks after wearing each prosthesis
Population: Each participant wore both study prostheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Frustration | 66.8 scores on a scale | Standard Deviation 29.7 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Social Burden | 85.2 scores on a scale | Standard Deviation 19.5 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Appearance | 85.6 scores on a scale | Standard Deviation 9.58 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Sounds | 71.4 scores on a scale | Standard Deviation 27.1 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Perceived Response | 87.6 scores on a scale | Standard Deviation 20.7 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Utility | 73.1 scores on a scale | Standard Deviation 14.8 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Residual Limb Health | 73.6 scores on a scale | Standard Deviation 19.4 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Well-Being | 72.9 scores on a scale | Standard Deviation 26.9 |
| Unpowered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Ambulation | 75.2 scores on a scale | Standard Deviation 18.3 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Well-Being | 79.2 scores on a scale | Standard Deviation 22 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Ambulation | 84.0 scores on a scale | Standard Deviation 15.8 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Appearance | 80.6 scores on a scale | Standard Deviation 12.8 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Frustration | 84.8 scores on a scale | Standard Deviation 27.8 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Perceived Response | 97.1 scores on a scale | Standard Deviation 4.33 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Residual Limb Health | 79.9 scores on a scale | Standard Deviation 14.3 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Social Burden | 91.6 scores on a scale | Standard Deviation 15.3 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Sounds | 57.2 scores on a scale | Standard Deviation 31.5 |
| BiOM Powered Prosthesis | Prosthetic Evaluation Questionnaire (PEQ) | Utility | 74.4 scores on a scale | Standard Deviation 16.7 |
Comparison: Ambulation Scorep-value: 0.058t-test, 2 sided
Comparison: Appearance Scorep-value: 0.123t-test, 2 sided
Comparison: Frustration Scorep-value: 0.052t-test, 2 sided
Comparison: Perceived Response Scorep-value: 0.188t-test, 2 sided
Comparison: Residual Limb Health Scorep-value: 0.336t-test, 2 sided
Comparison: Social Burden Scorep-value: 0.043t-test, 2 sided
Comparison: Sounds Scorep-value: 0.391t-test, 2 sided
Comparison: Utility Scorep-value: 0.799t-test, 2 sided
Comparison: Well-Beingp-value: 0.173t-test, 2 sided
Secondary
Time to Fatigue
Participants walk on a treadmill at a fast speed until they felt they can no longer continue. The time to fatigue was recorded.
Time frame: Testing took place after wearing the prostheses for two weeks
Population: Each participant wore both study prostheses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unpowered Prosthesis | Time to Fatigue | 14.7 minutes | Standard Deviation 12.1 |
| BiOM Powered Prosthesis | Time to Fatigue | 13.2 minutes | Standard Deviation 10.8 |
p-value: 0.212t-test, 2 sided