Effectiveness of an Inpatient Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation

Starting soon

Conditions studied: Diabetes Mellitus, Transfemoral Amputation, Peripheral Arterial Disease, Vascular Thrombosis

In brief

Patients with vascular and metabolic transfemoral amputations experience substantial functional limitations and high rates of prosthetic abandonment. Although multidisciplinary inpatient rehabilitation programs have been associated with improved outcomes, evidence regarding their effectiveness in low- and middle-income countries remains limited. This study aims to evaluate the effectiveness of an inpatient rehabilitation and prosthetic training model implemented at the National Institute of Rehabilitation "Luis Guillermo Ibarra Ibarra" (INRLGII), Mexico. An ambispective cohort design will be used, including a retrospective review of patients treated between 2013 and 2025 and a prospective cohort enrolled between 2026 and 2029. The primary objective is to determine the proportion of patients who achieve functional prosthesis use after hospital discharge. Secondary objectives include identifying clinical, metabolic, functional, and psychosocial factors associated with successful prosthetic use, adherence, and abandonment.

Key facts

Study ID

NCT07665775

Run by

Instituto Nacional de Rehabilitacion

People needed

54

Starts

2026-06-19

Expected to finish

2030-09-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications.
• Participation in the INRLGII inpatient prosthetic rehabilitation program.
• Availability of complete clinical records or willingness to participate in follow-up assessments .
• Signed informed consent.

You may not qualify if…

• Current prosthesis user before admission to the INRLGII rehabilitation program.
• Bilateral major lower-limb amputation.
• Inability to complete follow-up assessments.
• Withdrawal Criteria
• Incomplete or inconsistent clinical information.
• Loss to follow-up during the 6-month observation period.
• Participant withdrawal of consent.

Where it is running

• Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra — Mexico City, Mexico City, Mexico

Full record on ClinicalTrials.gov

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