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NCT07664995
Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
Conditions: Lower Limb Amputation Above Knee, Below Knee Amputation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: University of Illinois at Chicago
Location: University of Illinois Chicago Chicago Illinois
Summary
The goal of this clinical trial is to learn if ischemic conditioning and neuromuscular electrical stimulation improves muscle strength and walking behavior in those with limb loss. The main questions this trial aims to answer are:
Does neuromuscular electrical stimulation improve muscle strength and gait behavior in people who have a leg amputation?
Does neuromuscular electrical stimulation boost the effects of ischemic conditioning on muscle strength and gait behavior in people who have a leg amputation?
Researchers will compare the effects of neuromuscular electrical stimulation to ischemic conditioning to see if there are any significant differences between the impacts of each intervention. Also, researchers will use both interventions together to see if the interventions can boost each other's positive impacts on walking and function in people with leg amputation.
Participants will:
* Do ischemic conditioning OR neuromuscular electrical stimulation OR both interventions at home every other day for 2 weeks
* Visit the laboratory before and after completing interventions for the tests
* Visit the laboratory one week after the post intervention visit for follow-up tests
Eligibility Criteria
Inclusion Criteria:
* Older than 18 years old
* History of unilateral transfemoral or transtibial amputation
* Able to ambulate independently without the use of aids (i.e., walking cane)
* Able to walk at least 6 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:
* Younger than 18 years old
* Inability to give informed consent
* Neurological disorder such as multiple sclerosis that affects gait
* Currently pregnant (or intend to become pregnant while participating in study)
* 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
* Implanted electrical device such as a pacemaker or defibrillator
* Head injury within the previous 6 months
* Seizure disorder
* History of thrombosis
* History of sickle cell trait
* History of genetic disease that impacts gait (e.g. cerebral palsy, muscular dystrophy).
Source: ClinicalTrials.gov (NCT07664995). StuddyBuddy aggregates publicly available trial information.