Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
NCT ID: NCT05929508
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2024-04-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Ischemic Conditioning on Strength and Ambulation in Subjects with PAD
NCT04937179
Effect of Tourniquet Use on Muscle Thigh Function.
NCT03473106
The Relationship of Quadriceps and Hamstring Strength on Timed up and go Scores in Transtibial Amputees
NCT07067203
The Effect of Isokinetic Strengthening Training
NCT02938416
Relationship Between the Functional Movement Screen and Isokinetic Muscle Strength of Knee in Different Sport Branches
NCT05964556
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Clinicians and researchers often focus on the prosthetic fit to improve outcomes, however just providing a prosthetic, even the most advanced prosthetic, is not enough to restore function. Interventions targeting physical capabilities to complement device intervention may be key to improving outcomes in individuals with LLA.
Along with increased orthopaedic risks, individuals with traumatic LLA also have an increased risk of cardiovascular events compared to the general population. SMs with traumatic unilateral transfemoral amputation have a 1.58 times greater risk of death from cardiovascular causes and their relative risk of aortic aneurysm is 5.1 times greater than Veterans without amputation. There is evidence to suggest that individuals with LLA have increased peripheral vascular resistance following amputation, leading to vasoconstriction and increased blood pressure. Reduced arterial function (i.e. increased arterial stiffness) is an important measure in those with LLA because it predicts mortality, heart failure, and cardiovascular events. In addition, improved arterial function improves perfusion to muscle and reduces fatigue during exertion. Therefore, strategies that reduce arterial stiffness and vascular resistance in individuals with LLA are important to improve mortality and quality of life for SMs and Veterans.
Therefore, we propose implementing ischemic preconditioning (IC) as a novel intervention to strengthen and hypertrophy leg muscles and increase arterial function for improving outcomes after amputation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ischemic Preconditioning at High Pressure
In this arm, the participant will receive ischemic preconditioning (a blood pressure cuff on the intact limb) inflated to 225mmHg for 5 minutes followed by 5 minutes of reperfusion on a cycle for a total of 50 minutes. This will be completed every other day for 7 session (14 days).
Ischemic Preconditioning
A blood pressure cuff will be placed on the thigh of the intact/sound limb to restrict blood flow to the lower extremity for 5 minutes and then deflated for 5 minutes to allow for normal blood flow on a cycle for 50 minutes (5 times).
Ischemic Preconditioning at Low Pressure
In this arm, the participant will receive ischemic preconditioning (a blood pressure cuff on the intact limb) inflated to 25mmHg for 5 minutes followed by 5 minutes of reperfusion on a cycle for a total of 50 minutes. This will be completed every other day for 7 session (14 days).
Ischemic Preconditioning
A blood pressure cuff will be placed on the thigh of the intact/sound limb to restrict blood flow to the lower extremity for 5 minutes and then deflated for 5 minutes to allow for normal blood flow on a cycle for 50 minutes (5 times).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ischemic Preconditioning
A blood pressure cuff will be placed on the thigh of the intact/sound limb to restrict blood flow to the lower extremity for 5 minutes and then deflated for 5 minutes to allow for normal blood flow on a cycle for 50 minutes (5 times).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* History of lower limb unilateral transfemoral amputation.
* At least two years post lower limb amputation
* Able to ambulate independently without the use of aids (i.e., walking cane).
* Able to walk at least 10 minutes continuously without stopping.
* Has a safe residuum with no open wounds on either the residual or intact limb.
* Has a prosthetic limb with materials that are sound and safe to withstand the mobility requirements of the study.
Exclusion Criteria
* Inability to give informed consent.
* Neurological disorder that affects gait.
* Participants with significant metal (greater than one orthopaedic screw) in either the residual limb or the sound/intact limb
* Participants who begin taking medications or change dosage of medications that could affect gait, balance, and cardiovascular function during the course of the study.
* Currently pregnant (or intend to become pregnant while participating in study).
* History of any condition where fatiguing contractions or resisted leg contractions are contraindicated.
* Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg).
* History of uncontrolled hypertension.
* History of heart failure.
* Head injury within the previous 6 months.
* Seizure disorder.
* History of vascular disease.
* History of thrombosis.
* History of sickle cell trait.
* History of genetic disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Illinois at Chicago
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lindsay Hannigan
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lindsay Slater
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UIC Physical Therapy Faculty Practice
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-0250
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.