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NCT Number: NCT07665775

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

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Functional Prosthesis Use at 6 Months

    Time frame: 6 months after hospital discharge.

    Functional prosthesis use defined as prosthesis use ≥8 hours per day and a Houghton Scale score ≥9.

Secondary outcomes

  1. Houghton Scale Score

    Time frame: Time Frame: 3 and 6 months after discharge.

    Functional mobility and prosthetic use assessed using the Houghton Scale (0-12 points).

  2. Daily Prosthesis Use

    Time frame: 3 and 6 months after discharge.

    Average number of hours per day the prosthesis is used.

  3. Factors Associated With Functional Prosthesis Use

    Time frame: Baseline, 3 months, and 6 months.

    Association between functional use and demographic, clinical, metabolic, and psychosocial variables.

Study contacts

Contact information is provided by the study sponsor or research team.

LAURA PAULINA Muñoz Velasco, Medical Doctor

CONTACT

[email protected]

+525559991000 ext. 13213

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Rehabilitacion

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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