Testing new prosthetic devices for amputees
MOTU++ - Studio Clinico Protesi
NA · Fondazione Don Carlo Gnocchi Onlus · NCT06616402
This study is testing new smart prosthetic devices for people with leg amputations to see if they make walking easier and safer in everyday life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 1 site (Florence, FI) |
| Trial ID | NCT06616402 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the usability and reliability of innovative prosthetic devices designed for individuals with trans-femoral or trans-tibial amputations. The devices feature an intelligent socket that detects biosignals and provides vibrotactile feedback, along with active knee and ankle joints that assist in optimizing the gait cycle. Participants will be experienced prosthesis users who have been wearing a prosthesis for at least one year. The study will assess the functionality and safety of these prototype devices during daily activities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with lower limb amputations at the transfemoral or transtibial level who have been using a prosthesis for at least one year.
Not a fit: Patients with significant medical comorbidities, cognitive impairments, or severe depressive symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for amputees through advanced prosthetic technology.
How similar studies have performed: Other studies have shown promise in the development of advanced prosthetic technologies, indicating a potential for success in this innovative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 80 years; * Lower limb amputation at the transfemoral or transtibial level; * Functional medical classification: Level K3-K4 \[25\]; * Subjects wearing a prosthesis for at least 1 year (experienced wearers); * Maximum body weight 100 kg. Exclusion Criteria: * Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits. * Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators. * Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation. * Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research. * Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation. * Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.
Where this trial is running
Florence, FI
- IRCCS Fondazione Don Carlo Gnocchi — Florence, FI, Italy (RECRUITING)
Study contacts
- Study coordinator: Claudio Macchi, MD
- Email: cmacchi@dongnocchi.it
- Phone: 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.
Conditions: Amputation, Traumatic Amputations, Leg Amputation