Microprocessor-controlled Prosthetic Knees for Fall Safety
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
Recruiting
N/AInterventional Study
AmputationProsthesis UserAmputation; Traumatic, Leg: Thigh, Between Hip and KneeLimb; Absence, Congenital, LowerLower Limb Amputation Above Knee (Injury)Lower Limb Amputation Above Knee
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
100 (estimated)
Sponsor
Hanger Institute for Clinical Research and Education, LLC · Industry
Who this trial is looking for
This trial is looking for adults who have lost a leg above the knee and currently use a specific type of prosthetic knee. Participants will either continue using their current prosthetic or receive a new microprocessor-controlled prosthetic knee to see which is better for their health and mobility.
Are You a Good Fit for This Trial?
You may be able to join if
I have lost a leg above the knee.
I have been using my prosthesis for at least 6 months.
I currently use a non-microprocessor-controlled prosthetic knee.
I received a new non-microprocessor knee in the last 4-24 months.
My doctor says I am a limited community ambulator.
I can read, write, and understand English.
You may not be able to join if
I have a health condition that prevents me from participating safely.
I weigh 275 lbs or more.
I wear my prosthesis less than 3 days a week or for less than 24 hours a week.
I have had issues with my residual limb breaking down.
My health has declined so much that I've been less active in the past 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 above-knee prostheses. The main questions are:
* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?
* Do in…
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 above-knee prostheses. The main questions are:
* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?
* Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?
Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.
Trial Locations
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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 mon…
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
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