Evaluating new devices to prevent falls in amputees
Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
This study is testing new ways to see if certain markers can help predict fall risks in people with leg amputations to make their prosthetic devices safer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT06883942 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputations, specifically focusing on trans-femoral and trans-tibial amputees. Participants will undergo a series of evaluations while wearing their prostheses, including tests on experimental platforms designed to simulate tripping and slipping scenarios. The study will compare newly obtained fall risk markers with established clinical markers to validate their effectiveness. The overall goal is to enhance the safety and reliability of prosthetic devices for amputees.
Who should consider this trial
Good fit: Ideal candidates include individuals with trans-femoral or trans-tibial amputations who have been using a prosthesis for at least one year and have a functional medical classification of Level K3-K4.
Not a fit: Patients with significant medical comorbidities, cognitive impairments, or severe psychological symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety measures for amputees, reducing their risk of falls.
How similar studies have performed: While the approach of evaluating fall risk in amputees is not widely tested, similar studies focusing on fall prevention in other populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Trans-femoral or trans-tibial lower limb amputation; * Functional medical classification: Level K3-K4; * Subjects who have had a prosthesis for at least 1 year (experienced wearers); * Informed consent signed by the subject Exclusion Criteria: * Significant medical comorbidities (severe neurological disease, cardiovascular disease diabetes/unstabilised hypertension, severe sensory deficits); * Cardiac device wearers (PMK or AICD); * Cognitive impairment (MMSE adjusted for age and schooling \<24); * Inability or unwillingness to provide informed consent; * Severe depressive symptomatology - Beck Depression Inventory (BDI-II \<19); * Severe anxiety symptoms - State-Trait Anxiety Inventory (STAI-Y \<50).
Where this trial is running
Florence
- IRCCS Fondazione Don Carlo Gnocchi — Florence, Italy (Recruiting)
Study contacts
- Study coordinator: Claudio Macchi, MD
- Email: cmacchi@dongnocchi.it
- Phone: +39 0557393909
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.