NCT06937242 Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
| NCT ID | NCT06937242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hanger Institute for Clinical Research and Education, LLC |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-11 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Shane R. Wurdeman, PhD
PRINCIPAL INVESTIGATOR
Hanger Institute for Clinical Research and Education
Frequently Asked Questions
Who can join the NCT06937242 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06937242 currently recruiting?
Yes, NCT06937242 is actively recruiting participants. Contact the research team at swurdeman@hanger.com for enrollment information.
Where is the NCT06937242 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT06937242 clinical trial?
NCT06937242 is sponsored by Hanger Institute for Clinical Research and Education, LLC. The principal investigator is Shane R. Wurdeman, PhD at Hanger Institute for Clinical Research and Education. The trial plans to enroll 100 participants.