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Muscle Strength Training in Lower Limb Amputee Patients

Effects of Muscle Strength Training in Lower Limb Amputee Patients

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07261852
Enrollment
18
Registered
2025-12-03
Start date
2025-11-30
Completion date
2027-12-31
Last updated
2025-12-03

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

Conditions

Lower Limb Amputation

Keywords

amputees, quality of life, funcionality, muscle strength, movility, endurance training

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.

Interventions

OTHERMuscle 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.

OTHERResistence 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.

Sponsors

University of Gran Rosario
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Funcionalityday 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.It is assessed using the TUG test, which requires patients to get up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down again. Patients will receive the following instructions: Get up on the word 'go,' walk to the tape, turn around, walk back to the chair, and sit down.
Changes in quality of lifeday 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.It is assessed using a self-administered questionnaire called WHOQOL-BREF, which provides a profile of the person's perceived quality of life.

Secondary

MeasureTime frameDescription
Changes in Maximum isometric muscle strengthday 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.It is evaluated using a dynamometer, in which three measurements are taken for each designated movement and the average of the maximum force and peak force is calculated.
Changes on Movilityday 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.It is assessed using the AMP functional rating scale (amputee mobility predictor).
Change in Global percepcion of changeassessments were performed at the end each protocol. day 18 and day 24It is an assessment carried out using the Groc scale, which evaluates changes in perception.

Contacts

Primary ContactGabriela B Dell´Elce
gdellelce@ugr.edu.ar+54 3462344478

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026