Lower Limb AmputationNCT07261852
Muscle Strength Training in Lower Limb Amputee Patients
A study testing Muscle strengh training and Resistence training in people with Lower Limb Amputation, run by University of Gran Rosario.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Muscle strengh training and Resistence training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral lower limb amputation
- Transtibial and/or transfemoral amputation
- Prosthetized
- Aged 18 to 75 years
- Who sign the informed consent form
Who cannot join
- That they are unable to complete the initial assessment
- That they undergo further secondary training
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of 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.
Read the 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
- Being tested
- Muscle strengh training, Resistence training
- Keywords
- amputees, quality of life, funcionality, muscle strength, movility, endurance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strengh trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Muscle strength training | Experimental | 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. Receives: Other: Muscle strengh training |
| Endurance training | Active comparator | 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. Receives: Other: Resistence training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Funcionality
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."
Measured: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
Changes in quality of life
It is assessed using a self-administered questionnaire called WHOQOL-BREF, which provides a profile of the person's perceived quality of life.
Measured: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
Secondary outcomes (3)
Changes in Maximum isometric muscle strength
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.
Measured: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
Changes on Movility
It is assessed using the AMP functional rating scale (amputee mobility predictor).
Measured: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
Change in Global percepcion of change
It is an assessment carried out using the Groc scale, which evaluates changes in perception.
Measured: assessments were performed at the end each protocol. day 18 and day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start30 Nov 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Dell Elce, University of Gran Rosario
- Investigators
- Mauro S Barone, Study director, Ugr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261852
- Sponsor's protocol ID
- 619/2024
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If necessary or required, informed consent and data analysis will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Strength Training in Lower Limb Amputee Patients
- ClinicalTrials.gov ID
- NCT07261852
- Acronym / sponsor ID
- 619/2024
- Conditions
- Lower Limb Amputation
- Keywords
- amputees, quality of life, funcionality, muscle strength, movility, endurance training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle strength training | Experimental | Other: Muscle strengh trainingStrength 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 | Active comparator | Other: Resistence trainingResistance 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with unilateral lower limb amputation
- Transtibial and/or transfemoral amputation
- Prosthetized
- Aged 18 to 75 years
- Who sign the informed consent form
Key exclusion criteria (2 listed)
- That they are unable to complete the initial assessment
- That they undergo further secondary training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle strengh trainingStrength 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. | Other | Muscle strength training |
| Resistence trainingResistance 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. | Other | Endurance training |
Primary outcome
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."
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.
3 secondary outcomes
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.
Changes on Movility
Time frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
Change in Global percepcion of change
Time frame: assessments were performed at the end each protocol. day 18 and day 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Yes. If necessary or required, informed consent and data analysis will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mauro S Barone study director
Ugr
Questions about this trial
What is this clinical trial studying?
A study testing Muscle strengh training and Resistence training in people with Lower Limb Amputation, run by University of Gran Rosario.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela B Dell´Elce (+54 3462344478, gdellelce@ugr.edu.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Funcionality (time frame: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.