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

N/ANot Yet RecruitingNCT07664995

University of Illinois at Chicago24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Limb Amputation Above Knee Below Knee Amputation

Interventions

Blood pressure cuffDEVICE

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).

Neuromuscular Electrical StimulationDEVICE

Neuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Illinois Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Change from baseline in the self-selected gait speed (m/s) at week 3 and 4

Participants will be asked to walk at their self-selected gait speed (m/s) for 6 minutes on a split-belt treadmill at the 1st, 9th, and 10th visits. The change in gait speed from the first visit will be calculated by SPSS v. 31.0

Time frame: 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.

Participants will be positioned supine on a treatment table with a neutral position (legs shoulder-width apart) and will hold their arms by their chest. The handheld dynamometer will be placed at 20 centimeters distal to the greater trochanter. For participants with shorter residual limbs, the lever arm will be adjusted, and the handheld dynamometer will be placed on the distal side of the residual limb. Participants will be asked to perform three maximal contractions for 3 to 5 seconds with a 1-minute rest interval for each limb. The highest score of the three maximal contractions will be used for analysis. During all strength measurements, verbal encouragement will be given.

Time frame: 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

Participants will be asked to walk at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits. The changes in gait kinematics (angle) at the ankle, knee, hip joints, and trunk will be analyzed using waveform analysis from the first visit.

Time frame: 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

Participants will be asked to walk at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits. The changes in gait kinetics (N.m) at the ankle, knee, hip joints, and trunk will be analyzed using waveform analysis from the first visit.

Time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation

Secondary Outcomes

Changes from baseline in daily mobility tasks (%) using the Prosthetic Limb Users Survey of Mobility short form at the 3rd and 4th weeks

-Prosthetic Limb Users Survey of Mobility short form is a validated, patient-reported outcome measure used to assess the mobility of adults with lower limb amputations. It takes about 2 minutes to complete and is widely. Responses are converted into a standardized T-score. A score of 50 represents the average mobility of a prosthetic limb user.

Time frame: 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

Participants will wear an activity monitor to assess daily steps. We will compare the average daily steps before and after receiving the assigned interventions.

Time frame: 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

Time frame: 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

Participants will be asked to walk while wearing a silicone face mask at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits. Changes in walking economy (ml O₂/kg/min) will be analyzed by assessing the amount of oxygen used (ml O₂), normalized for both body weight (kg) and walking duration (min).

Time frame: 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

Participants will be asked to lay supine on a treatment table for 15 minutes so that blood pressure and cardiac function are similar to basal resting condition for repeatability and to minimize noise. Central blood pressure and arterial stiffness will be measured using the SphygmoCor. Carotid-femoral pulse wave velocity is a measure of the time for the arterial pulse to circulate from the carotid to the femoral artery and is considered the gold standard for arterial stiffness measure. We will measure waveforms on the same side as the intact limb. All measurements will be made in duplicate and averaged, or triplicate if the difference between two measures is greater than 0.5m/s.

Central Contacts

Nikou Nikoumanesh

CONTACT

857-919-4211 nniko@uic.edu

Data from ClinicalTrials.gov

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Time frame: 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

The Prosthetic Socket Fit Comfort Score is a validated, 11-point self-report scale (ranging from 0 to 10) used by individuals with amputations and their prosthetists to measure and track the comfort of an artificial limb. O represents the most uncomfortable socket fit, and 10 represents the most comfortable socket fit.

Time frame: 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

Nottingham Health Profile is a patient-reported questionnaire designed to measure subjective, health-related quality of life. It takes about 5 minutes to complete and requires simple "yes" or "no" answers. Scores are calculated using a weighted algorithm and range from 0 (no distress) to 100 (maximum distress).

Time frame: 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

The Activities-specific Balance Confidence Scale: For each of the specified activities, participants will indicate the level of confidence in doing the activity without losing their balance or becoming unsteady by choosing one of the percentage points on the scale from 0% (No Confidence) to 100% (Completely Confident)

Time frame: 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

Oswestry Low Back Pain is widely considered the "gold standard" for measuring how lower back or leg pain impacts a patient's daily functional abilities. This test consists of 10 sections evaluating different aspects of daily living. For each category, the participant will select the single statement that best describes their situation.

Time frame: 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

Participants will wear an activity monitor to calculate the sedentary time (s) per day. We will compare the average sedentary time before and after receiving the assigned interventions.

Time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation