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| ID | Type | Description | Link |
|---|---|---|---|
| U.S. NIH 1R01HD116422-01A1 | Other Grant/Funding Number | National Institute of Health |
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| Name | Class |
|---|---|
| Arizona State University | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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The goal of this clinical trial is to understand the feasibility and effectiveness of using reinforcement learning to personalize robotic prosthetic legs (an experimental prototype) for unilateral transfemoral amputees. The main questions it aims to answer are:
Participants will go through the standard prosthetic fitting procedures, such as alignment adjustment, then they will experience repeated prosthesis personalization procedures conducted by tuning specialists without RISE, tuning specialists with RISE, and prosthetists (without tuning expertise) with RISE on different types of terrains. In the end, the participants will go through a testing trial, in which they will experience the prototype personalized through the three different approaches without knowing how the control parameters are decided. Their walking performance will be recorded. It is expected that the participants will visit the testing site 8 times, which including alignment (1 visit), three personalization procedures (twice for each), and one testing trial (1-2 visits).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tuning expert without RISE | Active Comparator | Tuning experts decide the control parameters based on their knowledge about the powered prosthetic device and patients' feedback |
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| Tuning expert with RISE | Active Comparator | The control parameters of the prosthetic legs are decided by tuning experts with the help of the developed RISE system |
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| Prosthetists with RISE | Active Comparator | Control parameters of the prosthetic leg are decided by prosthetists, who are not familiar with the prosthetic leg prototype, with the RISE system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RISE guided personalization of prosthetic legs by tuning experts | Device | The personalization procedure is conducted by tuning experts based on the recommendation of RISE system |
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| Measure | Description | Time Frame |
|---|---|---|
| Total personalization time | Time needed to finish the personalization of the prosthetic leg | During the visit arranged for personalization |
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed | The walking speed of the participants when the prosthetic leg is personalized using one of the three personalization procedures | During the last visit for evaluation |
| Step length |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Liu, PhD | Contact | 9195158541 | mliu10@ncsu.edu | |
| Laura Rohrbaugh, BS | Contact | 919-513-3840 | lasmith6@ncsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| He (Helen) Huang, PhD | NC State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina State University | Recruiting | Raleigh | North Carolina | 27695 | United States |
Based on the requirement of local IRB, we will not share IPD information with other researchers and only deidentified data will be shared.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2025 | Sep 2, 2025 |
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During the evaluation trial, the participants and evaluators are blinded on how the personalized parameters are decided.
| RISE guided personalization of prosthetic legs by prosthetists | Device | The control parameters of the prosthetic leg prototype is decided by prosthetists without detailed knowledge about the prosthetic leg with the help of developed RISE system |
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| Manual personalization of the prosthetic leg by tuning experts | Device | The control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response. |
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Length of step when the participant walking with the prosthetic leg, of which control parameters are decided by one of the three personalization approaches.
| During the last visit for evaluation |
| foot elevation | Maximum height of the foot during swing when the control parameters of the prosthetic legs are decided by one of the three personalization procedures | during the last visit for evaluation |
| ICF_000.pdf |