Microprocessor-controlled prosthetic knees for limited community ambulators with above-knee 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 is a 12-month pragmatic randomized controlled trial enrolling unilateral transfemoral or knee-disarticulation prosthesis users classified as limited community ambulators (Medicare K2). Eligible participants who recently received a non-microprocessor knee as part of routine care will be randomized to continue their current non-microprocessor knee or receive a microprocessor-controlled knee (Ottobock C-Leg 4 or Kenevo). The trial will track fall-related health outcomes (including anxiety, self-efficacy, avoidance behaviors, and fall frequency) as well as mobility measures, walking speed, and health-related quality of life. Participants are recruited through routine prosthetic care with scheduled fittings and follow-up visits at participating clinics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Unilateral transfemoral or knee disarticulation limb loss.
* 6 months or longer since time of limb loss.
* Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.
* Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.
* Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).
* In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:

  1. Houghton Score: 5-10
  2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes \<49.45, otherwise, \<36.75.
  3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
* Ability to read, write, and understand English.

Exclusion Criteria:

* Any health condition that would prevent safely completing trial activities.
* Any individuals that weigh 275 lbs or more.
* Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week
* Individuals with a history of acute or chronic residual limb breakdown
* Individuals with declining health status such that he/she subsequently reports reduced activity over the past 6 months

Where it's running

• Hanger Inc.
  Austin, Texas, United States Recruiting

Study contacts

• Principal investigator: Shane R. Wurdeman, PhD — Hanger Institute for Clinical Research and Education
• Study coordinator: Shane R. Wurdeman, PhD
• Email: swurdeman@hanger.com
• Phone: 281-829-4746

Similar studies

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

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• Exploring touch sensations to improve feedback in prosthetics

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  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Marseille and 1 other locations · NCT05548322

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.