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

NCT07664995 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026_0262
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lower Limb Amputation Above Knee; Below Knee Amputation

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

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

Secondary Outcomes (10)

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

  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

  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

  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

  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

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

Study Arms (3)

Ischemic Conditioning

ACTIVE COMPARATOR

Device: Blood pressure cuff

Neuromuscular Electrical Stimulation

EXPERIMENTAL

Device: Neuromuscular Electrical Stimulation

Neuromuscular Electrical Stimulation + Ischemic Conditioning

EXPERIMENTAL

Device: Blood pressure cuff; Device: Neuromuscular Electrical Stimulation

Interventions

Blood pressure cuff DEVICE

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).

Ischemic Conditioning; Neuromuscular Electrical Stimulation + Ischemic Conditioning

Neuromuscular Electrical Stimulation DEVICE

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

Neuromuscular Electrical Stimulation; Neuromuscular Electrical Stimulation + Ischemic Conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60607, United States

Location

Central Study Contacts

Nikou Nikoumanesh

CONTACT

857-919-4211; nniko@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)