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New treatment option for Amputation
Official title Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
ClinicalTrials.gov ID: NCT06937242
What this study is testing
- What it's testing
- 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)?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility 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:
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.