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

NCT07665775 | Not Yet Recruiting

• 1 other identifier: INRLGII 03/26
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Transfemoral Amputation; Vascular Amputation; Diabetes Mellitus; Prosthetic Rehabilitation; Lower Limb Amputation; Prosthesis Use; Prosthetic Adherence; Prosthetic Abandonment; Functional Outcomes; Inpatient Rehabilitation; Multidisciplinary Care; Houghton Scale

Outcome Measures

Primary Outcomes (1)

• Functional Prosthesis Use at 6 Months

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

  6 months after hospital discharge.

Secondary Outcomes (3)

• Houghton Scale Score

  Time Frame: 3 and 6 months after discharge.

• Daily Prosthesis Use

  3 and 6 months after discharge.

• Factors Associated With Functional Prosthesis Use

  Baseline, 3 months, and 6 months.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications who are treated through the inpatient prosthetic rehabilitation program at the National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra (INRLGII), Mexico.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, 14389, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Arterial Disease; Thrombosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Embolism and Thrombosis

Central Study Contacts

LAURA PAULINA Muñoz Velasco, Medical Doctor

CONTACT

+525559991000; lpmunoz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)