Effectiveness of an Inpatient Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Transfemoral Amputation, Peripheral Arterial Disease, Vascular Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of an Inpatient Multidisciplinary Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation Treated at a National Rehabilitation Center: An Ambispective Cohort Study
Overview
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.
Detailed description
Background
Diabetes mellitus and peripheral vascular disease are major causes of lower-limb amputation worldwide. Transfemoral amputation is associated with substantial disability, increased energy expenditure during ambulation, reduced mobility, and decreased quality of life. Despite advances in prosthetic technology, long-term prosthetic use remains challenging, with reported abandonment rates ranging from 30% to 60%.
The National Institute of Rehabilitation "Luis Guillermo Ibarra Ibarra" (INRLGII) has developed a multidisciplinary inpatient rehabilitation and prosthetic training model for patients with vascular and metabolic amputations. The program integrates rehabilitacion medicine, physical therapy, occupational therapy, psychology, cardiopulmonary evaluation, biomedical engineering, and prosthetic fabrication in a coordinated inpatient setting.
Although international evidence suggests that inpatient multidisciplinary rehabilitation improves functional outcomes and prosthetic success, no institutional or national studies have systematically evaluated the effectiveness of this model in Mexican patients with vascular and metabolic transfemoral amputation.
Objective
To evaluate the effectiveness of an inpatient multidisciplinary rehabilitation and prosthetic training model in patients with unilateral transfemoral amputation of vascular or metabolic etiology.
Study Design
This is an observational, longitudinal, ambispective cohort study.
The retrospective phase will include patients treated between 2013 and 2025 through review of electronic medical records.
The prospective phase will include consecutive patients enrolled between 2026 and 2029. Functional prosthesis use will be assessed at 3 and 6 months after discharge using the Houghton Scale and structured recording of daily prosthesis use.
Hypothesis
The inpatient rehabilitation and prosthetic training model is associated with a higher proportion of functional prosthesis use at 6 months compared with rates reported in the international literature for vascular and metabolic transfemoral amputees
Primary outcome measures
- Functional Prosthesis Use at 6 Months [Time frame: 6 months after hospital discharge.]
Secondary outcome measures (3)
- Houghton Scale Score [Time frame: Time Frame: 3 and 6 months after discharge.]
- Daily Prosthesis Use [Time frame: 3 and 6 months after discharge.]
- Factors Associated With Functional Prosthesis Use [Time frame: Baseline, 3 months, and 6 months.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Mexico · 1 center
- Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra — Mexico City
Identifiers
NCT: NCT07665775 · INRLGII 03/26