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

Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees

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.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hanger Institute for Clinical Research and Education, LLC (Industry-sponsored)
• Locations: 1 site (Austin, Texas)
• Trial ID: NCT06937242 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with a unilateral transfemoral or knee-disarticulation amputation at least 6 months prior who currently use a non-microprocessor prosthetic knee, received a replacement non-microprocessor knee 4–24 months ago, meet K2 (limited community ambulator) criteria, and can read and understand English are ideal candidates.

Not a fit: People who are high-functioning ambulators (K3/K4), have medical conditions that prevent safe participation, weigh 275 pounds or more, or have bilateral above-knee amputations are unlikely to benefit from or be eligible for this protocol.

Why it matters

Potential benefit: If successful, the intervention could reduce falls and fall-related health burdens while improving mobility, walking speed, and quality of life for K2 prosthesis users.

How similar studies have performed: Prior research has shown benefits of microprocessor knees in higher-functioning (K3+) users, but evidence in K2 limited community ambulators is limited, making this a relatively novel application for that group.

Eligibility criteria

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 this trial is running

Austin, Texas

• 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

Conditions Amputation; Prosthesis User; Traumatic, Leg: Thigh, Between Hip and Knee; Limb; Absence, Congenital, Lower; Lower Limb Amputation Above Knee; amputation; lower limb amputation