Ischemic Conditioning + Neuromuscular Electrical Stimulation for Lower Limb Amputation

NN
Overseen ByNikou Nikoumanesh
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ischemic conditioning and neuromuscular electrical stimulation (which uses electrical impulses to stimulate muscles) can help individuals with leg amputations improve muscle strength and walking ability. Researchers aim to determine if these treatments are more effective alone or in combination. Participants will try one or both treatments at home for two weeks, with lab visits before and after. Individuals who have had a single leg amputation, can walk independently without aids, and have a safe and sound prosthetic limb are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance rehabilitation methods for amputees.

What prior data suggests that ischemic conditioning and neuromuscular electrical stimulation are safe for individuals with leg amputation?

Research shows that neuromuscular electrical stimulation (NMES) is generally safe and well-tolerated by patients. A recent review found NMES to be safe and practical, with no major negative side effects reported. Additionally, studies on lower limb conditions have shown that NMES can improve muscle strength and function.

Ischemic conditioning also appears safe. Although specific data is less detailed, the trial's "Not Applicable" phase designation suggests these interventions are considered low risk.

In summary, previous research has shown both neuromuscular electrical stimulation and ischemic conditioning to be safe, providing confidence for their use in this trial.12345

Why are researchers excited about this trial?

Researchers are excited about using ischemic conditioning and neuromuscular electrical stimulation for lower limb amputation because they offer a fresh approach to rehabilitation. Unlike traditional treatments that focus mainly on physical therapy and prosthetics, ischemic conditioning involves temporarily restricting blood flow to enhance muscle recovery and adaptation. Neuromuscular electrical stimulation directly activates muscles through electrical impulses, potentially speeding up muscle strengthening and function. These techniques may work together to promote better healing and faster recovery, providing new hope for improved mobility and quality of life for amputees.

What evidence suggests that this trial's treatments could be effective for improving muscle strength and walking behavior in people with leg amputation?

Research has shown that neuromuscular electrical stimulation (NMES) can significantly enhance muscle strength and prevent muscle loss. NMES has effectively stopped muscle wasting in very sick patients, suggesting it could also strengthen muscles after an amputation. In this trial, some participants will receive NMES alone, while others will receive ischemic conditioning alone. Additionally, one treatment arm will combine NMES with ischemic conditioning. Using NMES with ischemic conditioning has been linked to improved movement and overall physical ability. Specifically, patients who used both treatments showed better results in walking and muscle function. This combination may work even better together, particularly for enhancing walking and muscle strength in individuals with leg amputations.678910

Are You a Good Fit for This Trial?

This trial is for adults who have had an above-knee or below-knee leg amputation. Participants should be able to do home-based exercises and attend lab visits before, after, and one week following the intervention period.

Inclusion Criteria

I have a prosthetic limb that is safe and suitable for study activities.
History of unilateral transfemoral or transtibial amputation
I can walk on my own without using any walking aids.
See 3 more

Exclusion Criteria

I do not have blood clots or open wounds in my legs.
I have had high blood pressure that is not well controlled.
I am unable to understand or agree to participate in this study.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants perform ischemic conditioning, neuromuscular electrical stimulation, or both interventions at home every other day

2 weeks
2 visits (in-person) before and after interventions

Follow-up

Participants visit the laboratory for follow-up tests to assess changes in muscle strength and gait behavior

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ischemic Conditioning
  • Neuromuscular Electrical Stimulation

Trial Overview

The study tests whether using a blood pressure cuff (for ischemic conditioning), neuromuscular electrical stimulation, or both can improve muscle strength and walking in people with leg amputations. Participants are assigned to different groups for two weeks of at-home treatment.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Neuromuscular Electrical Stimulation + Ischemic ConditioningExperimental Treatment2 Interventions
Group II: Neuromuscular Electrical StimulationExperimental Treatment1 Intervention
Group III: Ischemic ConditioningActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

The effects of neuromuscular electrical stimulation on ...

In this study, the effectiveness of neuromuscular electrical stimulation (NMES) was evaluated in lower extremity rehabilitation in patients with ...

Early Application of Neuromuscular Electrical Stimulation ...

A randomized controlled trial found that daily NMES for seven consecutive days significantly reduced quadriceps muscle thickness loss compared ...

Does Neuromuscular Electrical Stimulation as an Adjunct ...

The outcome measured in the included studies was improvement in post- operative mobility demonstrated via various tests evaluating walking and ...

(PDF) Effectiveness of neuromuscular electrical stimulation ...

Results: Primary outcome is limb spasticity status. Secondary outcomes comprise of limb function, quality of life, and adverse events. Conclusion: This study ...

2018 - Effectiveness of Neuromuscular Electrical Stimulat

NMES had moderate benefits on lower limb motor function, especially when combined with other treatments or used for 6-12 weeks. NMES also improved gait speed, ...

Neuromuscular Electrical Stimulation Increases Muscle ...

In a post-surgical patient only NMES therapy is safe in the early phase of recovery. Later on in the Rehab, NMES can be combined with BFR, ...

Neuromuscular Electrical Stimulation Combined With ...

CONCLUSIONS: Combining NMES with rehabilitation training can enhance motor function recovery, attenuate muscle atrophy, and improve walking ...

Blood pressure cuff et Neuromuscular Electrical Stimulation à ...

The goal of this clinical trial is to learn if ischemic conditioning and neuromuscular electrical stimulation improves muscle strength and walking behavior ...

A Systematic Review: NMES for Muscle Strength in SCI

The findings of this systematic review suggest that NMES is an effective intervention for improving muscle strength and functional outcomes in ...

Neuromuscular Electrical Stimulation in Foot and Ankle ...

Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using ...