Understanding the impact of powered prosthetics on walking for transfemoral amputees

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 evaluate how powered knee and ankle prosthetics affect the walking ability of K2-level transfemoral amputees. Participants will use either a commercially available passive microprocessor knee prosthesis or a powered knee and ankle prosthesis, with assessments focused on functional performance. The study will also explore the effects of intensive clinical gait training on these powered devices. The hypothesis is that powered componentry will enhance ambulation and that training will further improve outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ages 18-95
* A unilateral transfemoral amputation
* At least 6 months since definitive prosthesis fitting
* Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person.
* Medically cleared by physician to participate in study
* English speaking

Exclusion Criteria:

* Weight greater than 250 pounds
* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
* 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. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
* Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Suzanne Finucane, MS, PTA
• Email: sfinucane@sralab.org
• Phone: 312-238-0937

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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.