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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto Nacional de Rehabilitacion

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Current prosthesis user before admission to the INRLGII rehabilitation program.

Bilateral major lower-limb amputation.

Inability to complete follow-up assessments.

Incomplete or inconsistent clinical information.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

54 Participants
are grouped into 1 trial group
Group A: Patients With Vascular or Metabolic Transfemoral Amputation Undergoing Inpatient Prosthetic Rehabili

Trial outcomes

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.

Time frame
6 months after hospital discharge.

Secondary outcomes

1

Houghton Scale Score

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

Time frame
Time Frame: 3 and 6 months after discharge.
2

Daily Prosthesis Use

Average number of hours per day the prosthesis is used.

Time frame
3 and 6 months after discharge.
3

Factors Associated With Functional Prosthesis Use

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

Time frame
Baseline, 3 months, and 6 months.

Other outcomes

Sponsors and contacts

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