Rehabilitation after transfemoral amputation for moderately active patients
Observational Study on Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients, Provided With Kenevo (Ottobock)
This study tests whether longer rehabilitation after a leg amputation helps moderately active patients recover better and adjust to using advanced prosthetic legs compared to standard rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Median Academic / other |
| Locations | 1 site (Wiesbaden) |
| Trial ID | NCT06045468 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of early inpatient rehabilitation following transfemoral amputation, focusing on the implementation of treatment guidelines to optimize patient outcomes. Patients will be assigned to either a study group receiving extended rehabilitation or a control group with standard rehabilitation duration. The study will monitor rehabilitation progress through multiple outcome measurements during and after the rehabilitation period, comparing the use of microprocessor-controlled prostheses against traditional options. The goal is to provide evidence supporting longer rehabilitation durations to enhance recovery and prosthetic fitting.
Who should consider this trial
Good fit: Ideal candidates are German-speaking individuals who are undergoing inpatient rehabilitation after transfemoral amputation or knee disarticulation and have an anticipated K-level of 1 or 2.
Not a fit: Patients who are non-German speaking, unable to give informed consent, or weigh over 125kg may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that enhance recovery and quality of life for patients after transfemoral amputation.
How similar studies have performed: While there are existing guidelines for rehabilitation after amputation, this study aims to provide new evidence for their implementation, making it a novel approach in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * inpatient rehabilitation stay after transfemoral amputation or knee disarticulation * anticipated K-level 1 or 2 * body weight no more than 125kg (authorized body weight for prosthetic device) * German speaking * able to give informed consent Exclusion Criteria: * non-German speaking * not able to give informed consent * body weight over 125kg
Where this trial is running
Wiesbaden
- MEDIAN Clinics — Wiesbaden, Germany (Recruiting)
Study contacts
- Study coordinator: Johannes Schröter, Dr. med.
- Email: johannes.schroeter@median-kliniken.de
- Phone: 0049611757811
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.