Evaluation of a powered prosthesis for individuals with transfemoral amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the functional mobility, control, and user satisfaction of individuals who have undergone osseointegration and targeted muscle reinnervation surgeries while using a powered knee and ankle prosthesis. Participants will be fitted with a custom socket for EMG signal collection and will undergo training with the powered prosthesis. The study will evaluate perceived benefits such as reduced weight perception, decreased energy expenditure during movement, and improved EMG signal quality. Data will be collected through multiple lab visits prior to surgical intervention and during the use of the powered prosthesis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Unilateral lower limb amputation at the transfemoral level
* Existing prosthesis wearer
* K2/K3/K4 level ambulation
* 18-70 years old
* Mini-Mental State Exam (MMSE) score greater than 17
* Ability to demonstrate proper safety with passive prosthesis
* Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes
* Candidate for OI surgery as verified by surgical team or has previously received OI
* Candidate for TMR surgery as verified by surgical team or has previously received TMR

Exclusion Criteria:

* Unable to successfully receive osseointegration and TMR
* Significant new injury that would prevent use of a prosthesis: Ability to consistently wear prosthesis and perform activities of daily living and specific performance tasks is necessary to properly evaluate the relative benefits of the intervention
* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data.
* Visually impaired
* Proximal nerve injury that prevents TMR
* Individuals who smoke: may interfere with OI process from both bone healing and soft tissue standpoints
* Individuals with active implants.
* Significant comorbidity that would preclude completion of the study, use of prostheses, or would otherwise prevent data acquisition by researchers

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Levi Hargrove, PhD — Shirley Ryan AbilityLab
• Study coordinator: Suzanne Finucane, MS, PTA
• Email: sfinucane@sralab.org
• Phone: 312-238-0937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing powered and mechanical prosthetic knees for K2-level amputees

  This study is testing whether powered prosthetic knees work better than mechanical ones for K2-level amputees to help improve their mobility and make better choices for future prosthetic designs.

  Recruiting Liberating Technologies, Inc. · Austin, Texas · NCT06194838

• Effect of EMG sensor number and placement on control of below-elbow prosthetic arms

  This project will test whether changing the number and placement of myoelectric sensors helps adults with below-elbow limb absence control a prosthetic arm better while wearing a real device.

  Recruiting Liberating Technologies, Inc. · Chicago, Illinois and 1 other locations · NCT07011420

• Microprocessor-controlled prosthetic knees for limited community ambulators with above-knee amputation.

  This test will see if switching to a microprocessor-controlled prosthetic knee reduces fall-related health problems and improves walking speed, mobility, and quality of life for adults with above-knee amputations who are limited community ambulators compared with non-microprocessor knees.

  Recruiting Hanger Institute for Clinical Research and Education, LLC · Austin, Texas · NCT06937242

• Understanding the impact of powered prosthetics on walking for transfemoral amputees

  This study is testing whether powered knee and ankle prosthetics can help transfemoral amputees walk better, especially when combined with special training.

  Recruiting Shirley Ryan AbilityLab · Chicago, Illinois · NCT06433648

• Evaluation of a new myoelectric prosthesis for transradial amputees

  This study is testing a new type of prosthetic arm that uses a special implant to help people with below-the-elbow amputations control it more easily and naturally.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT05768802

• Hand prosthesis usability and performance evaluation for people with upper limb absence

  This study tests a new multi-articulating hand prosthesis to see if it performs better or differently than a participant’s own prosthesis.

  Recruiting Össur Iceland ehf · Dublin, Ohio · NCT07915700

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.