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NCT Number: NCT07261852

Muscle Strength Training in Lower Limb Amputee Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle strengh training

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.

Resistence training

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.

Primary outcomes

  1. Changes in Funcionality

    Time frame: day 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."

  2. Changes in quality of life

    Time frame: day 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 outcomes

  1. Changes in Maximum isometric muscle strength

    Time frame: day 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.

  2. Changes on Movility

    Time frame: day 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).

  3. Change in Global percepcion of change

    Time frame: assessments were performed at the end each protocol. day 18 and day 24

    It is an assessment carried out using the Groc scale, which evaluates changes in perception.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela B Dell´Elce

CONTACT

[email protected]

+54 3462344478

Sponsors and collaborators

Lead sponsor

University of Gran Rosario

Other

Registry information

Official study title

Effects of Muscle Strength Training in Lower Limb Amputee Patients

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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