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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powered Ankle Prosthesis | Experimental | In this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants will wear the device for 2 weeks. |
|
| Dynamic Response Foot | Sham Comparator | In this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powered ankle prosthesis | Device | This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Cost of Walking | Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed. | Testing took place after wearing the prostheses for two weeks |
| 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 | 2 weeks |
| 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. | Questionnaire completed 2 weeks after wearing each prosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deanna H Gates, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33726802 | Derived | Kim J, Wensman J, Colabianchi N, Gates DH. The influence of powered prostheses on user perspectives, metabolics, and activity: a randomized crossover trial. J Neuroeng Rehabil. 2021 Mar 16;18(1):49. doi: 10.1186/s12984-021-00842-2. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Powered Ankle Prosthesis, Then Unpowered Prosthesis | In this condition, the participant was fitted with a powered prosthetic ankle by a certified prosthetist to start the study. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket. They then wore their prescribed prosthesis for 2 weeks, while their activity was monitored, before returning to the lab for testing. |
| FG001 | Unpowered Prosthesis, Then Powered Ankle Prosthesis | In this arm, participants will start in their clinically prescribed dynamic response foot. They first wore their prescribed prosthesis for 2 weeks, while their activity was monitored. They then came to the laboratory for testing. Participants were then fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Weeks) |
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| Second Intervention (3 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | This group represents all participants enrolled in the study. |
| 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 | Metabolic Cost of Walking | Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed. | 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 | Posted | Mean | Standard Deviation | J/Nm | Testing took place after wearing the prostheses for two weeks |
|
Adverse events were monitored through study completion for each participant, which was approximately 3 months time.
If an adverse event were to occur, it would be reported to the University of Michigan IRB and study sponsor for review.
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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 | Powered Ankle Prosthesis | In this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). After accommodation, participants wore the device for 2 weeks. Powered ankle prosthesis: This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status. We monitored for adverse events the entire time the participant had the device at home for accommodation and monitoring (~ 3 weeks) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deanna Gates | University of Michigan | (734) 647-2698 | gatesd@umich.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 | Apr 2, 2020 | Aug 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000673 | Amputation, Traumatic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Dynamic Response Foot | Device | This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear. |
|
| Questionnaire completed 2 weeks after wearing each prosthesis |
| 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. | Testing took place after the participant wore the prosthesis for 2 weeks |
| 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. | Testing took place after wearing the prostheses for two weeks |
| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Each participant in the study wore both prostheses | Posted | Mean | Standard Deviation | steps | 2 weeks |
|
|
|
|
| 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. | Each participant in the study wore both prostheses | Posted | Mean | Standard Deviation | scores on a scale | Questionnaire completed 2 weeks after wearing each prosthesis |
|
|
|
|
| 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 | Each participant wore both study prostheses. | Posted | Mean | Standard Deviation | scores on a scale | Questionnaire completed 2 weeks after wearing each prosthesis |
|
|
|
|
| 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. | Each participant wore both study prostheses | Posted | Mean | Standard Deviation | percentage of maximum signal | Testing took place after the participant wore the prosthesis for 2 weeks |
|
|
|
|
| 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. | Each participant wore both study prostheses | Posted | Mean | Standard Deviation | minutes | Testing took place after wearing the prostheses for two weeks |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Unpowered Prosthesis | In this arm, participants will wear their clinically prescribed dynamic response foot (unpowered prosthesis). This period is 2 weeks long. Dynamic Response Foot: This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear. We monitored for adverse events the entire time the person wore their device at home and were monitored (2 weeks). | 0 | 12 | 0 | 12 | 0 | 12 |
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| t-test, 2 sided |
| 0.408 |
Statistical significance was set a-priori at p<0.05 |
| Superiority |
| Frustration |
|
| Perceived Response |
|
| Residual Limb Health |
|
| Social Burden |
|
| Sounds |
|
| Utility |
|
| Well-Being |
|
| .123 |
Statistical significance was set a-priori at p<0.05. |
| Other |
paired t-test between conditions |
| Frustration Score | t-test, 2 sided | .052 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Perceived Response Score | t-test, 2 sided | .188 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Residual Limb Health Score | t-test, 2 sided | .336 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Social Burden Score | t-test, 2 sided | .043 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Sounds Score | t-test, 2 sided | .391 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Utility Score | t-test, 2 sided | .799 | Statistical significance was set a-priori at p<0.05. | Superiority | paired t-test between conditions |
| Well-Being | t-test, 2 sided | .173 | Statistical significance was set a-priori at p<0.05. | Superiority |
| Intact side soleus |
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| Intact side tibialis anterior |
|
| Residual side biceps femoris |
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| Residual side rectus femoris |
|
Intact Side Rectus Femoris
| t-test, 2 sided |
| .281 |
Statistical significance was set a-priori at p<0.05. |
| Other |
paired t-test between conditions |
| Intact Side Soleus | t-test, 2 sided | .844 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Intact Side Tibialis Anterior | t-test, 2 sided | .110 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Residual Side Biceps Femoris | t-test, 2 sided | .394 | Statistical significance was set a-priori at p<0.05. | Other | paired t-test between conditions |
| Residual Side Rectus Femoris | t-test, 2 sided | .141 | Statistical significance was set a-priori at p<0.05. | Superiority |