Multidisciplinary rehabilitation for patients with lower limb amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-Task Balance Training for Traumatic Lower-Limb Prosthesis Users

  This trial tests whether adding dual-task balance training to standard rehab helps improve balance and mobility for adults with traumatic leg amputations who use a prosthesis.

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• Footwear effects on walking in people with a leg prosthesis

  This study tests four different types of footwear to see how they affect walking in adults with a unilateral transtibial amputation who use a prosthetic foot.

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• 3D-printed resin versus zirconia for implant crowns and short bridges in the lower front jaw

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.