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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-21-1-0686 | Other Grant/Funding Number | Department of Defense Congressionally Directed Medical Research Program |
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In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation. Of individuals with amputation in veteran and service member populations, approximately 35% present with an above the knee amputation. It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait, safety, comfort, confidence, reduced falls, balance, patient satisfaction and reduced energy expenditure, greater ease in negotiating varying terrains, improvements in multi-tasking and cost effectiveness. Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee. Therefore, clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient. This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Microprocessor Prosthetic Knee | Experimental | Randomization to C-Leg 4.0, Rheo Knee and Power Knee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microprocessor prosthetic knee | Device | Microprocessor prosthetic knees for use in a transfemoral prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ten Meter Walking Test | Self selected walking speed over ten meters of walking over ground. | 1 month |
| Two Minute Walking Test | Self selected walking speed over two minutes of walking over ground. | 1 month |
| Prosthetic Evaluation Questionnaire (PEQ) | A patient reported survey on perceptions of a prosthesis. Scores range zero to one hundred with zero being representing a negative patient reported outcome and one hundred representing a positive patient reported outcome. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Stance Time Asymmetry Index | Stance time asymmetry index measures the percent difference in stance time between the prosthetic and sound side limbs. A value equal to zero is indicative of perfect symmetry. Negative values of ST asymmetry index are indicative of increased time spent on the sound side and positive values are indicative of increased time on the prosthetic side. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Institute of Technology | Atlanta | Georgia | 30332 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41133928 | Derived | Herrin K, Kestur S, Zhou S, O'Sullivan G, Snow T, Childers WL, Young A. Toward personalizing prosthesis prescription: A take-home study of three microprocessor-controlled prosthetic knees: A randomized crossover study. PM R. 2026 Mar;18(3):288-304. doi: 10.1002/pmrj.70028. Epub 2025 Oct 24. |
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Knee condition order was randomized prior to enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prosthetic Knee Randomized | Each participant performed study activities while wearing a prosthetic knee for one week, followed by a different knee for the second week, and finally a third knee for the third week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. Each participant wore all three knees and were randomized as to which knee they wore on which week. The three knees worn were the Ottobock C-Leg 4.0, Ossur Rheo, and Ossur Power Knee. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Microprocessor Prosthetic Knee | Randomization to C-Leg 4.0, Rheo Knee and Power Knee |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Ten Meter Walking Test | Self selected walking speed over ten meters of walking over ground. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Meters per second | 1 month | Prosthetic Knees | Prosthetic Knees |
|
4 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 | Ottobock C-Leg 4.0 | Each participant performed study activities while wearing the Ottobock C-Leg 4.0 prosthetic knee for one week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kinsey Herrin, MSPO, C/LPO, FAAOP, Senior Research Scientist | Georgia Institute of Technology | 470-578-7600 | kinsey.herrin@gatech.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 8, 2024 | Jun 24, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2023 | Jun 24, 2024 | ICF_001.pdf |
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| Narrowing Beam Walking Test | A measure of balance via walking down a narrowing beam. | 1 month |
| Reported Falls | Average reported falls per day. | 1 month |
| Physiological Cost Index | A clinical measure of energy expenditure. This formula consists of working heart minus resting heart rate divided by speed. | 1 month |
| Stair Ascent Speed | Self selected walking speed during stair ascent. | 1 month |
| Stair Descent Speed | Self selected walking speed while descending stairs. | 1 month |
| Ramp Ascent Speed | Self selected walking speed while ascending a 5 degree incline. | 1 month |
| Ramp Descent Speed | Self selected walking speed while descending a 5 degree incline. | 1 month |
| Steps Per Day | Steps per day as measured by StepWatch. | 1 month |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | Meters |
|
| Weight | Mean | Standard Deviation | Kilograms |
|
| AMPnoPro | The Amputee Mobility Assessment Tool with no Prothesis tool (AMPnoPro) is a 20 item objective measure to characterize mobility. Range is 0 to 43, whereas the higher the score, the more mobility observed. | Data was not collected from the one participant who did not complete the study. | Mean | Standard Deviation | units on a scale |
|
| Clinically Prescribed Prosthetic Knee | Current clinically prescribed knee used in everyday prosthesis. | Count of Participants | Participants |
|
|
|
|
| Primary | Two Minute Walking Test | Self selected walking speed over two minutes of walking over ground. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Meters per second | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Primary | Prosthetic Evaluation Questionnaire (PEQ) | A patient reported survey on perceptions of a prosthesis. Scores range zero to one hundred with zero being representing a negative patient reported outcome and one hundred representing a positive patient reported outcome. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | units on a scale | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Stance Time Asymmetry Index | Stance time asymmetry index measures the percent difference in stance time between the prosthetic and sound side limbs. A value equal to zero is indicative of perfect symmetry. Negative values of ST asymmetry index are indicative of increased time spent on the sound side and positive values are indicative of increased time on the prosthetic side. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | percentage of stance time | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Narrowing Beam Walking Test | A measure of balance via walking down a narrowing beam. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Feet | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Reported Falls | Average reported falls per day. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Falls per day | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Physiological Cost Index | A clinical measure of energy expenditure. This formula consists of working heart minus resting heart rate divided by speed. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Heart beats per meter | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Stair Ascent Speed | Self selected walking speed during stair ascent. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Steps per minute | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Stair Descent Speed | Self selected walking speed while descending stairs. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Steps per minute | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Ramp Ascent Speed | Self selected walking speed while ascending a 5 degree incline. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Meters per second | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Ramp Descent Speed | Self selected walking speed while descending a 5 degree incline. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Meters per second | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| Secondary | Steps Per Day | Steps per day as measured by StepWatch. | 1 participant did not complete any of the conditions due to self withdrawal after consenting. No data obtained from two participants due to experimental error. Each participant wore all three knees during this trial. | Posted | Mean | Standard Deviation | Steps per day | 1 month | Prosthetic Knees | Prosthetic Knees |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Ossur Rheo | Each participant performed study activities while wearing the Ossur Rheo prosthetic knee for one week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Ossur Power Knee | Each participant performed study activities while wearing the Ossur Power Knee prosthetic knee for one week. The participants in this study have a unilateral transfemoral amputation (i.e. one of their legs is amputated above the knee) and each participant uses a prosthesis to walk. | 0 | 11 | 0 | 11 | 0 | 11 |
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| C-Leg 4.0 |
|
|
| Rheo |
|
|
| ANOVA |
| 0.027 |
| Other |
One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary |
| An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Two Meter Walking Test. | ANOVA | 0.425 | Other | One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary |
| C-Leg 4.0 |
|
|
| Rheo |
|
|
The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the Rheo.
| Non-parametric Friedman's test with mult |
| 0.236 |
| Other |
Non-parametric Friedman's test with multiple comparison correction |
| The Non-parametric Friedman's test was used to compare the survey results between the participants using the Rheo and the C-Leg 4.0. | Non-parametric Friedman's test with mult | 0.118 | Other | Non-parametric Friedman's test with multiple comparison correction |
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| ANOVA |
| 0.024 |
| Other |
One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary. |
| An ANOVA was used to compare the Ramp Ascent Speed between the Rheo and the C-Leg 4.0. | ANOVA | 0.949 | Other | One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary. |
| C-Leg 4.0 |
|
|
| Rheo |
|
|
| C-Leg 4.0 |
|
|
| Rheo |
|
|