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Not Yet Recruiting NCT07665775

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

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 54
Sponsor: Instituto Nacional de Rehabilitacion

Location: Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra Mexico City Mexico City

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07665775). StuddyBuddy aggregates publicly available trial information.