Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation

Официальное название

Improving Muscle Strength and Function After Lower Limb Amputation

Обзор

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

Вмешательства

• Устройство Blood pressure cuff
  A blood pressure cuff will be used for ischemic conditioning, which is a non-invasive intervention that involves episodes of muscle ischemia (restriction of blood flow) followed by reperfusion (restoration of blood flow).
• Устройство Neuromuscular Electrical Stimulation
  Neuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions.

Первичные конечные точки

• Change from baseline in the self-selected gait speed (m/s) at week 3 and 4 [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Change from baseline in the hip's isometric muscle strength (N.m/kg) using a handheld dynamometer at the 3rd and 4th weeks. [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in gait kinematics (angle) through gait motion analysis at 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in gait kinetics (N.m) through gait motion analysis at 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]

Вторичные конечные точки (10)

• Changes from baseline in daily mobility tasks (%) using the Prosthetic Limb Users Survey of Mobility short form at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in average number of daily steps using an activity monitor at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in the mean seated systolic and diastolic blood pressure (mmHg) at 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in walking economy (mlO₂ /kg.min) at 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in the carotid-femoral pulse wave velocity (m/s) at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in socket comfort score (out f 10) at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in quality of life (%) using Nottingham Health Profile at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in the Activities-specific Balance Confidence Scale (%) at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in Oswestry Low Back Pain (%) at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]
• Changes from baseline in the average sedentary time (s) using an activity monitor at the 3rd and 4th weeks [Срок оценки: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Illinois Chicago — Chicago

Идентификаторы

NCT: NCT07664995 · 2026_0262

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗