Multidisciplinary rehabilitation for patients with lower limb amputation
Clinical and Psychological Adjustment of Patients With Lower Limb Amputation: a Multidisciplinary Rehabilitative Intervention Project (AMP_ADinRehab Study)
This study is testing whether a new technology-based rehabilitation program can help people adjust better after having a lower limb amputation compared to traditional rehab methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Pavia, PV) |
| Trial ID | NCT06471855 on ClinicalTrials.gov |
What this trial studies
This project focuses on the clinical and psychological adjustment of patients who have undergone lower limb amputation, primarily due to vascular disease and type 2 diabetes. It employs a biopsychosocial approach to evaluate behavioral and psychological adaptation at different stages of the condition, including the risk of amputation, the amputation itself, and the use of prosthetics. Patients will be randomized to receive either traditional rehabilitation or a technology-based rehabilitation intervention, with assessments conducted through semi-structured interviews and rating scales tailored to their specific disease stage.
Who should consider this trial
Good fit: Ideal candidates include individuals at risk of amputation or those who have undergone lower limb amputation and are using a prosthesis due to vascular disease and type 2 diabetes.
Not a fit: Patients over 80 years old or those with severe clinical conditions or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and psychological well-being of amputees, facilitating their reintegration into society.
How similar studies have performed: Previous studies have shown positive outcomes with multidisciplinary rehabilitation approaches for amputees, suggesting that this method is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Risk of amputation or Lower limb amputation or prothesis use for vascular disease and diabetes type 2 Exclusion Criteria: * more than 80 years older * severe clinical condition (ie, chronic heart failure \[New York Heart Association Classification-IV - NYHA-IV\], ischemic heart disease \[Canadian Cardiovascular Society Classification-IV - CCS-IV\], neoplastic disease, acute respiratory disease); * non-Italian education * severe visual-perceptive deficits * severe cognitive impairment (MMSE ≤ 26 Foderaro et al, 2022); * severe mental health condition or psychiatric disorder compromising participation in the study; * absence or withdrawal of the informed consent to participate.
Where this trial is running
Pavia, PV
- Istituti Clinici Scientifici Maugeri, IRCCS — Pavia, Pv, Italy (Recruiting)
Study contacts
- Principal investigator: Antonia Dr Pierobon — Istituti Clinici Scientifici Maugeri, IRCCS
- Study coordinator: Antonia Dr Pierobon
- Email: antonia.pierobon@icsmaugeri.it
- Phone: +390385247255
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.