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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Neuromuscular Electrical Stimulation

    Device

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

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Ischemic ConditioningActive comparator 1 intervention
Group B: Neuromuscular Electrical StimulationExperimental treatment 1 intervention
Group C: Neuromuscular Electrical Stimulation + Ischemic ConditioningExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

1

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
2

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
3

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
4

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

Other outcomes

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