Lower Limb Amputation Above KneeNCT07664995
Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
A study testing Blood pressure cuff and Neuromuscular Electrical Stimulation in people with Lower Limb Amputation Above Knee and Below Knee Amputation, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Above Knee, Below Knee Amputation
- What is being tested?
- Blood pressure cuff and Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60607
About this study
Official title: Improving Muscle Strength and Function After Lower Limb Amputation
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?
Read more
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
- Being tested
- Blood pressure cuff, Neuromuscular Electrical Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning | Active comparator | Not described Receives: Device: Blood pressure cuff |
| Neuromuscular Electrical Stimulation | Experimental | Not described Receives: Device: Neuromuscular Electrical Stimulation |
| Neuromuscular Electrical Stimulation + Ischemic Conditioning | Experimental | Not described Receives: Device: Blood pressure cuff; Device: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
-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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start7 Oct 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664995
- Sponsor's protocol ID
- 2026_0262
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Muscle Strength and Function After Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT07664995
- Acronym / sponsor ID
- 2026_0262
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 7 Oct 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure cuffA 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). | Device | Ischemic Conditioning, Neuromuscular Electrical Stimulation + Ischemic Conditioning |
| Neuromuscular Electrical StimulationNeuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions. | Device | Neuromuscular Electrical Stimulation, Neuromuscular Electrical Stimulation + Ischemic Conditioning |
Primary outcome
Change from baseline in the self-selected gait speed (m/s) at week 3 and 4
Time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
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
Change from baseline in the hip's isometric muscle strength (N.m/kg) using a handheld dynamometer at the 3rd and 4th weeks.
Time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
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.
Changes from baseline in gait kinematics (angle) through gait motion analysis at 3rd and 4th weeks
Time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
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.
Changes from baseline in gait kinetics (N.m) through gait motion analysis at 3rd and 4th weeks
Time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
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.
10 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
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
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
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
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
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
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
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
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
Time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure cuff and Neuromuscular Electrical Stimulation in people with Lower Limb Amputation Above Knee and Below Knee Amputation, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikou Nikoumanesh (857-919-4211, nniko@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the self-selected gait speed (m/s) at week 3 and 4 (time frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.