Status:
NOT_YET_RECRUITING
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
Lead Sponsor:
Hanger Institute for Clinical Research and Education, LLC
Collaborating Sponsors:
University of Washington
U.S. Army Medical Research Acquisition Activity
Conditions:
Amputation
Prosthesis User
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use...
Detailed Description
This study aims to assess the effects of microprocessor-controlled prosthetic knees on fall-related health outcomes in prosthesis users classified as limited community ambulators. This study also seek...
Eligibility Criteria
Inclusion
- Unilateral transfemoral or knee disarticulation limb loss.
- 12 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:
- Houghton Score: 5-10
- Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes \<49.45, otherwise, \<36.75.
- Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
- Ability to read, write, and understand English.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06937242
Start Date
April 1 2025
End Date
February 1 2027
Last Update
April 24 2025
Active Locations (1)
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1
Hanger Inc.
Austin, Texas, United States, 78758