Comparing walking abilities in people with osseointegrated prostheses and traditional socket prostheses
Instrumental Analysis of Walking in People With Osseointegrated Prostheses for Lower Extremity Amputation: Comparative Evaluation With Traditional Socket Prostheses
This study tests whether people with leg amputations walk better and have better balance using osseointegrated prostheses compared to traditional socket prostheses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 2 sites (Milan, MI and 1 other locations) |
| Trial ID | NCT04934839 on ClinicalTrials.gov |
What this trial studies
This study evaluates the walking abilities and balance of individuals with unilateral lower extremity amputation using osseointegrated prostheses compared to traditional socket-mounted prostheses. It employs neuro-physiologic and mechanical assessments, including tests on a force-sensorized split-belt treadmill. The goal is to understand the advantages of osseointegration, which may offer improved stability and quality of life for amputees. Participants will be monitored for their ability to follow instructions and provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with unilateral lower extremity amputation and a specific body mass index.
Not a fit: Patients with significant comorbidities or previous major lower limb surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation outcomes and quality of life for amputees using osseointegrated prostheses.
How similar studies have performed: Previous studies have shown positive outcomes with osseointegrated prostheses, suggesting potential for success in this comparative evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * unilateral lower extremity amputation; * age \> 18 years; * amputation-adjusted Body Mass Index between 18 and 25; * ability to understand the instructions; * ability to wittingly sign the informed consent form. Exclusion Criteria: * other previous knee injuries or major surgical interventions at the lower limbs; * comorbidities, such as neurological conditions, vascular diseases, or diseases of orthopedic, cardiac, or pulmonary origin; * cancer disease in the site under examination; * other neurological pathologies with impact on balance and gait.
Where this trial is running
Milan, MI and 1 other locations
- Istituto Auxologico Italiano — Milan, Mi, Italy (Recruiting)
- ASST Gaetano Pini-CTO — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Luigi Tesio, MD, Professor — Istituto Auxologico Italiano
- Study coordinator: Luigi Tesio, MD, Professor
- Email: l.tesio@auxologico.it
- Phone: +39 02 58218151
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.