Comparing passive and active microprocessor-controlled knees for amputees
Application Observation of Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation
Median · NCT06406491
This study is testing whether active microprocessor-controlled knees can help people with above-the-knee amputations walk better and feel more confident compared to passive ones.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Median (other) |
| Locations | 1 site (Wiesbaden) |
| Trial ID | NCT06406491 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in functional and patient-reported outcomes between passive microprocessor-controlled knees (pMPK) and active microprocessor-controlled knees (aMPK) in individuals with transfemoral amputation. Participants will use the Intuy Knee, an active prosthesis, for four weeks after baseline assessments with their current pMPK. Key measurements will include walking distance, stair climbing ability, mobility, daily functionality, quality of life, and fear of falling. The study aims to provide insights into the subjective experiences of prosthetic users and the potential benefits of active prosthetic technology.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and above with transfemoral amputation or knee disarticulation, currently using a passive microprocessor-controlled knee and anticipating a new prosthesis.
Not a fit: Patients who are under 18 years old or have a body weight exceeding 125 kg may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prosthetic options that enhance mobility and quality of life for amputees.
How similar studies have performed: While there is limited research on subjective evaluations of active versus passive prostheses, similar studies have shown promising results in improving mobility and functionality with active prosthetic devices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * transfemoral amputation or knee-disarticulation * passive microprocessor-controlled knee * resupply with new prosthesis within the next few months * K-Level 2 or 3 * body weight no more than 125 kg * German speakers Exclusion Criteria: * age less than 18 years * unable to give informed consent * body weight more than 125 kg
Where this trial is running
Wiesbaden
- MEDIAN Clinics — Wiesbaden, Germany (RECRUITING)
Study contacts
- Principal investigator: Johannes Schröter, Dr. med. — MEDIAN Reha-Center Wiesbaden Sonnenberg
- Study coordinator: Johannes Schröter, Dr. med.
- Email: johannes.schroeter@median-kliniken.de
- Phone: +49 611571751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, transfemoral amputation, prosthetic user, microprocessor-controlled knee, functional outcomes, patient-reported outcomes