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

Sponsor
Instituto Nacional de Rehabilitacion
Study ID
NCT07665775
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus
  • Peripheral Arterial Disease
  • Transfemoral Amputation
  • Vascular Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Jun 24, 2026
Start date
Jun 19, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
54 participants (estimated)

Arms

  • Arm: Patients With Vascular or Metabolic Transfemoral Amputation Undergoing Inpatient Prosthetic Rehabili
    Adult patients with unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications who participate in the inpatient prosthetic rehabilitation program at the National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra (INRLGII). Participants will be evaluated for functional prosthesis use, adherence, and factors associated with successful prosthetic rehabilitation.

Primary Outcome Measure

Functional Prosthesis Use at 6 Months [ Time Frame: 6 months after hospital discharge. ]

Central Contacts

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