Recruiting
Phase 1

RISE vs. Manual Personalization

Sponsor:

North Carolina State University

Code:

NCT07204925

Conditions

Transfemoral Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RISE guided personalization of prosthetic legs by tuning experts

RISE guided personalization of prosthetic legs by prosthetists

Manual personalization of the prosthetic leg by tuning experts

Study Details

Brief summary:

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:

  • With the developed RL-based Recommendation Interfacing System (RISE), clinicians are able to personalize prosthetic legs faster compared with existing manual personalization procedures.
  • With the developed RL-based Recommendation Interfacing System (RISE), clinicians are able to personalize prosthetic legs without detailed knowledge about how the prosthetic legs are controlled.
  • Patients perform better when the prosthetic legs are personalized with RISE system compared with the ones personalized manually Researchers will compare two arms (RISE guided personalization and manual personalization) to see if the tuning speed will increase and if patients can perform better.

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).

Conditions

Transfemoral Amputation

Study ID

NCT07204925

Start date

Aug 1, 2025

Status verified date

May, 2026

Completion date

Nov 1, 2029

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unilateral transfemoral amputees between 18-75 with K level three or higher
  • More than one year after amputation
  • Using current prosthetic socket and leg for more than three months
  • No major skin issues on the residual limb for more than six months
  • Can walk for more than 4 minutes continuously without any other assistive devices

Exclusion Criteria:

  • Have very short residual thighs (the length of the residual limb is <15% of the length of the unimpaired limb)
  • 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
  • Have any significant co-morbidity that interferes with the study (e.g. stroke, pacemaker placement, pain, etc.).

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Tuning expert without RISE

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

active comparator: Tuning expert with RISE

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

active comparator: Prosthetists with RISE

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

Interventions

RISE guided personalization of prosthetic legs by tuning experts

The personalization procedure is conducted by tuning experts based on the recommendation of RISE system

RISE guided personalization of prosthetic legs by prosthetists

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

Manual personalization of the prosthetic leg by tuning experts

The control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response.

Primary outcome measure

  • Total personalization time [ Time Frame: During the visit arranged for personalization ]

Central Contacts and Locations

Central contacts

Locations

North Carolina State University

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

More Information

Sponsor

North Carolina State University

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Powered prosthesis legs
  • control parameter personalization
  • reinforcement learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2026-05-19.