Effectiveness of an Inpatient Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Diabetes Mellitus, Transfemoral Amputation, Peripheral Arterial Disease, Vascular Thrombosis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Мексика
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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
Первичные конечные точки
- Functional Prosthesis Use at 6 Months [Срок оценки: 6 months after hospital discharge.]
Вторичные конечные точки (3)
- Houghton Scale Score [Срок оценки: Time Frame: 3 and 6 months after discharge.]
- Daily Prosthesis Use [Срок оценки: 3 and 6 months after discharge.]
- Factors Associated With Functional Prosthesis Use [Срок оценки: Baseline, 3 months, and 6 months.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Мексика · 1 центр
- Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra — Mexico City
Идентификаторы
NCT: NCT07665775 · INRLGII 03/26