Muscle Strength Training in Lower Limb Amputee Patients

NCT ID: NCT07261852

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-12-31

Brief Summary

This study is a clinical trial that evaluates the best treatment option using a strength training protocol and an endurance training protocol in patients with lower limb amputations who use prostheses. The protocol consists of 6 weeks of strength training and 6 weeks of endurance training, with a 1-month washout period between the two.

Detailed Description

The assessments in this study focus primarily on strength, using a dynamometer and the 5 RM, functionality, using the AMP scale, mobility, using the TugTest, quality of life, using the WHOQOL-BREF, and perception of change, using the GROC.

Conditions

Lower Limb Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Muscle strength training

Strength training lasts six weeks, during which submaximal strength percentages ranging from 75% to 90% are worked on.

It is performed three times a week and follows a protocol consisting of progressive exercises for the large functional muscle groups relevant to the population being trained.

Group Type: EXPERIMENTAL

Muscle strengh training

Intervention Type: OTHER

Strength training lasts six weeks, during which submaximal strength percentages ranging from 75% to 90% are worked on.

It is performed three times a week and follows a protocol consisting of progressive exercises for the large functional muscle groups relevant to the population being trained.

Endurance training

Resistance training will be carried out for 6 weeks, 3 times a week, with exercises prescribed by a protocol with training characteristics defined by bibliography found in the ACSM.

Group Type: ACTIVE_COMPARATOR

Resistence training

Intervention Type: OTHER

Resistance training will be carried out for 6 weeks, 3 times a week, with exercises prescribed by a protocol with training characteristics defined by bibliography found in the ACSM.

Interventions

Muscle strengh training

Strength training lasts six weeks, during which submaximal strength percentages ranging from 75% to 90% are worked on.

It is performed three times a week and follows a protocol consisting of progressive exercises for the large functional muscle groups relevant to the population being trained.

Intervention Type: OTHER

Resistence training

Resistance training will be carried out for 6 weeks, 3 times a week, with exercises prescribed by a protocol with training characteristics defined by bibliography found in the ACSM.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with unilateral lower limb amputation
• Transtibial and/or transfemoral amputation
• Prosthetized
• Aged 18 to 75 years
• Who sign the informed consent form

Exclusion Criteria

• That they are unable to complete the initial assessment
• That they undergo further secondary training

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gran Rosario

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Dell Elce

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro S Barone

Role: STUDY_DIRECTOR

Ugr

Central Contacts

Gabriela B Dell´Elce

Role: CONTACT

gdellelce@ugr.edu.ar

+54 3462344478

Other Identifiers

619/2024

Identifier Type: -

Identifier Source: org_study_id