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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07665775
Enrollment
54
Registered
2026-06-24
Start date
2026-06-19
Completion date
2030-09-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Peripheral Arterial Disease, Transfemoral Amputation, 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

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.

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

Interventions

None listed

Sponsors

Instituto Nacional de Rehabilitacion
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional Prosthesis Use at 6 Months6 months after hospital discharge.Functional prosthesis use defined as prosthesis use ≥8 hours per day and a Houghton Scale score ≥9.

Secondary

MeasureTime frameDescription
Houghton Scale ScoreTime Frame: 3 and 6 months after discharge.Functional mobility and prosthetic use assessed using the Houghton Scale (0-12 points).
Daily Prosthesis Use3 and 6 months after discharge.Average number of hours per day the prosthesis is used.
Factors Associated With Functional Prosthesis UseBaseline, 3 months, and 6 months.Association between functional use and demographic, clinical, metabolic, and psychosocial variables.

Countries

Mexico

Contacts

CONTACTLAURA PAULINA Muñoz Velasco, Medical Doctor
lpmunoz@gmail.com+525559991000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026