RISE Personalization for Below Knee Amputation

Overseen By Laura Rohrbaugh, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: North Carolina State University

Disqualifiers: Short residual limb, Height, Weight, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called RISE, which personalizes robotic prosthetic legs for individuals with an above-knee amputation. The goal is to determine if RISE can speed up the fitting process and enhance prosthetic performance compared to the usual manual method. Participants will try prosthetic legs adjusted in three different ways, including with and without the RISE system, across various terrains. This trial may suit those who had an above-knee amputation over a year ago, can walk unaided for 4 minutes, and currently use a prosthetic leg. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative system.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the RISE system for personalizing prosthetic legs is safe?

Research has shown that the RISE system for customizing prosthetic legs is generally safe. The RISE system enables experts to fit prosthetic legs more quickly and effectively. Researchers are testing it alongside traditional methods to determine if it improves walking with prosthetic legs.

As a Phase 1 study, the primary focus is to assess the system's safety for users. Early trials often evaluate safety by observing whether participants can use the new technology without serious side effects. Although specific safety data is not yet available, reaching this phase suggests researchers believe it is likely safe.

Overall, RISE personalization remains under testing, but it appears to be a promising and safe method to enhance walking with prosthetic legs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RISE guided personalization for prosthetic legs because it brings a new level of customization and precision to below-knee prosthetics. Unlike standard prosthetic fittings, which rely heavily on tuning experts' and prosthetists' general knowledge and patient feedback, the RISE system introduces an advanced method of determining control parameters, enhancing the fit and function of the prosthetic. This system allows for more individualized adjustments, potentially improving comfort and mobility for users. By integrating technology into the tuning process, RISE could significantly improve the quality of life for amputees by offering a more tailored and efficient approach to prosthetic leg personalization.

What evidence suggests that the RISE system is effective for personalizing prosthetic legs for below knee amputation?

This trial will compare different methods of customizing prosthetic legs for below-knee amputees. One arm involves tuning experts using their knowledge and patient feedback to adjust the prosthetics without the RISE system. Another arm involves tuning experts using the RISE system to assist in customization. A third arm involves prosthetists unfamiliar with the prosthetic leg prototype using the RISE system for adjustments. Research has shown that using the RISE system to customize prosthetic legs can help patients perform better than with manual adjustments. Studies have found that people with RISE-customized prosthetics often walk more easily and comfortably. The RISE system uses a smart computer program to quickly adjust the prosthetic leg to fit each person's unique needs. A review of prosthetic knees with microprocessors has also shown improvements in movement and quality of life, suggesting that advanced technologies like RISE could offer similar benefits. Overall, early evidence is promising for those seeking a more personalized prosthetic experience. ^{1 5 6 7 8}

Who Is on the Research Team?

He (Helen) Huang, PhD

Principal Investigator

NC State University

Are You a Good Fit for This Trial?

This trial is for individuals with a below-knee amputation. Participants will be involved in testing the personalization of robotic prosthetic legs using a system called RISE, as well as manual tuning by experts. They should be available to visit the testing site multiple times.

Inclusion Criteria

I am an amputee with one leg amputated above the knee and can walk with varying speeds.

I can walk for more than 4 minutes without help or devices.

It has been over a year since my amputation.

Exclusion Criteria

Are <1.50m in height or >116Kg in weight (who would not fit our prosthesis or the PowerKnee)

Have cognitive, visual, audio impairments that would affect their ability to give informed consent or to follow simple Instructions during the experiments

I do not have any major health issues that could affect my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prosthetic Fitting and Alignment

Participants undergo standard prosthetic fitting procedures, including alignment adjustment

1 visit

1 visit (in-person)

Personalization Procedures

Participants experience repeated prosthesis personalization procedures conducted by tuning specialists without RISE, tuning specialists with RISE, and prosthetists with RISE on different terrains

6 visits

6 visits (in-person)

Testing Trial

Participants undergo a testing trial to evaluate walking performance with the personalized prosthetic legs

1-2 visits

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the testing trial

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RISE guided personalization of prosthetic legs

Trial Overview The study tests if reinforcement learning via RISE can personalize prosthetic legs more efficiently than traditional manual methods. It compares personalization speed and patient performance across different terrains when using RISE-guided or manually tuned prosthetics.

How Is the Trial Designed?

Group I: Tuning expert without RISE Active Control 1 Intervention

Tuning experts decide the control parameters based on their knowledge about the powered prosthetic device and patients' feedback

Group II: Tuning expert with RISE Active Control 1 Intervention

The control parameters of the prosthetic legs are decided by tuning experts with the help of the developed RISE system

Group III: Prosthetists with RISE Active Control 1 Intervention

Control parameters of the prosthetic leg are decided by prosthetists, who are not familiar with the prosthetic leg prototype, with the RISE system.

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials

38

Recruited

50,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Citations

1. withpower.com withpower.com/trial/phase-1-transfemoral-amputation-7-2025-4d339

RISE Personalization for Below Knee Amputation * Patients perform better when the prosthetic legs are personalized with RISE system compared with the ones personalized manually Researchers will compare two ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9987462/

Impact of microprocessor prosthetic knee on mobility and ... Impact of microprocessor prosthetic knee on mobility and quality of life in patients with lower limb amputation: a systematic review of the literature · Abstract.

3. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2024.1454262/full

Recent progress on smart lower prosthetic limbs This review paper explores recent advancements in the integration of EEG and fNIRS modalities for smart lower prosthetic limbs for rehabilitation applications.

4. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-213-lower-limb-protheses-evidence-summary.pdf

Effective Health Care Program - Lower Limb Prostheses In adults who use a lower limb prosthesis, how do ambulatory, functional, and patient-centered outcomes with different prosthetic components vary.

5. medrxiv.org medrxiv.org/content/medrxiv/early/2025/07/22/2025.07.21.25331936.full.pdf

A 1 Sensor-Based Approach to Rehab 96. Conclusion. 97. A personalized intervention approach guided by integrated data and experts review may improve. 98 real-world outcomes in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449377/

A Review of Current State-of-the-Art Control Methods for ... In this paper, we present a review of existing control strategies for lower-limb powered prostheses, including the control objectives, sensing capabilities, ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/99/NCT03930199/Prot_SAP_000.pdf

STU00208186: Personalized Mobility Interventions using ... The system is a rating from 0 through 4 and it indicates a person's potential to use a prosthetic device if they had a device that worked well ...

8. researchgate.net researchgate.net/publication/393921784_Characterizing_Response_to_Personalized_Intervention_in_Lower_Limb_Prosthesis_Users_A_Sensor-Based_Approach_to_Rehabilitation

A Sensor-Based Approach to Rehabilitation | Request PDF Conclusion A personalized intervention approach guided by integrated data and experts review may improve real world outcomes in individuals with LLA. These ...