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| Name | Class |
|---|---|
| University of Notre Dame | OTHER |
| United States Department of Defense | FED |
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this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.
Some estimates suggest that by 2050, as many as 3.6 million people in the United States will be living with limb loss, and at least 60% of them will have had at least a foot removed For military personnel, combat-related amputations remain one of the most common major disabling war-related injuries from modern armed conflict. Technological advancements in active prosthetic devices for individuals with transtibial amputation offer the potential for superior function in key areas that could lead to higher rates of RTD and improved quality of life. Currently intended primarily for individuals with a K-level of 3 or 4, active transtibial prostheses that provide controlled plantar/dorsiflexion in either swing (microprocessor-controlled prostheses) or late stance (prostheses with powered propulsion) are likely to become the gold standard in the future as technology continues to improve Indeed, users of these types of prostheses have higher mobility than those using any of the other four categories of prosthetic ankle-foot mechanisms for unlimited community ambulators. Note that a major insurer has recently declared microprocessor-controlled ankle-foot prostheses medically necessary for members whose functional level is 3 or above.The PROPRIO FOOT® by Ossur, is a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. This added ankle control of these devices reduces the risk of falls by increasing toe clearance supports more natural standing posture on slopes and improves stair and slope ascent/descent capability by adapting to the change in terrain. On stairs, the PROPRIO FOOT® has been shown to improve affected leg knee kinematics (increased knee flexion) and kinetics (increased knee moment) instance. These improvements also contributed to higher interlimb symmetry reduced energetic cost of slope ascent and higher Amputee Mobility Predictor with a Prosthesis (AMPPRO) scores . Although the ankle of the PROPRIO FOOT® can be controlled in swing, the device does not have adequate power to provide an active propulsion instance. The Empower ankle by Ottobock is a powered prosthesis that provides active propulsion in late stance to mimic the positive work performed by the ankle plantar flexors in push-off. The Empower has been shown to improve affected leg kinematics (increased ankle range of motion and reduced knee flexion) on smooth flat ground ramp ascent and gravel]. In terms of kinetics, the Empower likewise results in increased ankle power on level ground stairs and ramps . Active prostheses like the PROPRIO FOOT® and Empower ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, perhaps enhancing RTD for military personnel. As with all prosthetic components, though, these active devices are of little use if they induce pain and/or injury at the residual limb to the degree that the user will simply not wear them. The investigators will examine how optimal fit of lower limb prostheses can impact individuals comfort and/or reduce irritation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proprio Foot | Experimental | each participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio |
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| Empower foot | Experimental | ach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROPRIO FOOT® by Ossur & Empower ankle by Ottobock | Device | PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation. |
| Measure | Description | Time Frame |
|---|---|---|
| Powered Transtibial Prosthesis on Socket Pressure | effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Perfusion | Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sashwati Roy, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46228 | United States |
The investigators will share deidentified patient data consisting of the patient PEQ and comfort scores and transpepidermal water loss data upon request.
6 months after completion
Email study contact
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| ID | Title | Description |
|---|---|---|
| FG000 | Proprio Foot, Then Empower Ankle | Participants started with the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. After four weeks of use, participants crossed over to use the Empower ankle by Ottobock, an active powered ankle prosthesis, for an additional four weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Oct 25, 2022 |
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| 4 weeks |
| Transepidermal Water Loss (TEWL) | Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL. | 4 weeks |
| FG001 |
| Empower Ankle, Then Proprio Foot |
Participants started with the Empower ankle by Ottobock, an active powered ankle prosthesis. After four weeks of use, participants crossed over to use the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for an additional four weeks. |
| COMPLETED |
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| NOT COMPLETED |
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all participants that have completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Proprio Foot, Then Empower Ankle | Participants started with the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase. After four weeks of use, participants crossed over to use the Empower ankle by Ottobock, an active powered ankle prosthesis, for an additional four weeks. |
| BG001 | Empower Ankle, Then Proprio Foot | Participants started with the Empower ankle by Ottobock, an active powered ankle prosthesis. After four weeks of use, participants crossed over to use the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for an additional four weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| participants completed the study visits | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Powered Transtibial Prosthesis on Socket Pressure | effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis | accurate in-socket pressure data could be only collected from 3 subjects | Posted | Mean | Standard Deviation | kPa/kg | 4 weeks |
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| Secondary | Change in Skin Perfusion | Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome. | accurate data only from n=4 participants were obtained in Empower foot. | Posted | Mean | Standard Deviation | Perfusion Units (PU) | 4 weeks |
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| Secondary | Transepidermal Water Loss (TEWL) | Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL. | Posted | Mean | Standard Deviation | g/m^2 x h | 4 weeks |
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period of all study visits from baseline (week 0) to final visit (week 8); each intervention was evaluated for four 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 | Proprio Foot | Participants who used the PROPRIO FOOT® by Ossur, a microprocessor-controlled prosthesis that regulates the angle of ankle dorsiflexion during the swing phase, for four weeks. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Empower Ankle | Participants who used the Empower ankle by Ottobock, an active powered ankle prosthesis, for four weeks. | 0 | 6 | 0 | 6 | 0 | 6 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sashwati Roy, PI | University of Pittsburgh | 412 6240422 | sar453@pitt.edu |
| Aug 31, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2022 | Aug 29, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D011475 | Prosthesis Failure |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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