NMES for Amputation

Overseen By Kyle Leister, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sara Peterson-Snyder

Disqualifiers: Severe diabetes, Open wounds, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method called Neuromuscular Electrical Stimulation (NMES) to help individuals with lower leg amputations rebuild muscle. It aims to improve muscle strength and reduce pain for a better prosthetic fit. Participants will use a device at home to stimulate muscles in their remaining limb. The trial seeks individuals who have had a lower leg amputation, experience pain, and have no open wounds on their limb. The goal is to enhance mobility and comfort, making daily life easier for prosthetic users. As an unphased trial, this study offers participants the chance to contribute to innovative research that could significantly improve the quality of life for prosthetic users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for individuals with transtibial limb loss?

Research has shown that Neuromuscular Electrical Stimulation (NMES) is generally safe and well-tolerated. A recent review found NMES to be safe and practical, benefiting muscle strength and function in patients recovering from heart problems. This suggests NMES can be a reliable option without major safety concerns.

Another study used NMES alongside regular rehabilitation for military amputees. The results showed no serious side effects, indicating that NMES is well-tolerated. Overall, these studies suggest NMES is a safe treatment option for improving muscle function and strength. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for amputation, which often focus on physical therapy and prosthetics, NMES (Neuromuscular Electrical Stimulation) offers a novel approach by directly stimulating the muscles in the residual limb. This technique uses a portable device that participants can use at home, providing convenience and potentially greater adherence. Researchers are excited because NMES targets specific muscle groups, like the vastus medialis oblique, tibialis anterior, and gastrocnemius, aiming to enhance muscle strength and control, which could improve mobility and quality of life for amputees.

What evidence suggests that NMES is effective for rebuilding muscle mass in individuals with transtibial limb loss?

Studies have shown that Neuromuscular Electrical Stimulation (NMES) can improve muscle strength and reduce pain in individuals who have lost a limb. In previous research, participants using NMES developed stronger muscles in their remaining limb and experienced less pain over time. This technique sends small electrical pulses to the muscles, prompting them to contract and strengthen. Early evidence suggests NMES may also enhance overall function and movement in amputees. In this trial, all participants will undergo an 8-week NMES intervention, using a portable NMES device at home to stimulate specific muscle groups in their residual limb. ^{2 6 7 8 9}

Who Is on the Research Team?

Kyle Leister, PhD

Principal Investigator

East Tennessee Sate University

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone transtibial amputation and are looking to improve muscle mass, function, and reduce pain in their residual limbs. Participants should be willing to undergo an 8-week NMES training program.

Inclusion Criteria

Have a minimum of 4" length limb from tibial tubercle to end of residuum to allow room for NMES pads

My BMI is 35 or less.

I have one leg amputated below the knee.

Exclusion Criteria

Have used electrical stimulation on the residual limb in the past six months

Wear a pacemaker or implanted cardiac defibrillator

I have severe diabetes or cannot feel my skin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week NMES program using a portable device at home to stimulate specific muscle groups.

8 weeks

Baseline, midpoint, and post-intervention assessments

Follow-up

Participants are monitored for changes in muscle parameters, pain, and gait biomechanics post-treatment.

9 months

What Are the Treatments Tested in This Trial?

Interventions

• NMES

Trial Overview The study tests the effectiveness of Neuromuscular Electrical Stimulation (NMES) using the Chattanooga Continuum Device on rebuilding muscle mass and reducing pain in people with below-knee amputations.

How Is the Trial Designed?

Group I: NMES Experimental Treatment 1 Intervention

All participants will undergo an 8-week Neuromuscular Electrical Stimulation (NMES) intervention using a portable NMES device at home. Participants will use the device on their residual limb to stimulate specific muscle groups (vastus medialis oblique, tibialis anterior, and gastrocnemius muscles). Electrode placement, stimulation intensity, and session frequency will be standardized and tailored to each participant to achieve strong but tolerable muscle contractions.

Who Is Running the Clinical Trial?

Sara Peterson-Snyder

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study of 309 patients undergoing major lower amputations, closed incision negative pressure wound therapy (CINPWT) did not significantly reduce the need for revision surgery compared to traditional gauze dressings (P = 0.45).

There was no significant difference in hospital mortality or survival rates between patients treated with CINPWT and those with gauze dressings, indicating that CINPWT may not provide additional benefits in terms of survival or revision surgery after non-traumatic major lower amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does closed incision negative wound pressure therapy in non-traumatic major lower-extremity amputations improve survival rates? Stenqvist, CP., Nielsen, CT., Napolitano, GM., et al.[2022]

A functional above-knee amputation stump can be created for patients with non-resectable tumors by using a small Austin-Moore prosthesis, which allows for the complete removal of the upper femur.

Muscle attachments are carefully sutured to the prosthesis to ensure proper balance and function of the stump, enhancing the patient's ability to use the prosthetic limb effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preservation of the functional above knee stump following hip disarticulation by means of an Austin-Moore prosthesis. Marcove, RC., McMillian, RD., Nasr, E.[2005]

Blast-related extremity trauma often leads to severe bone and soft tissue damage, making amputation a viable option for pain relief and improved function when limb salvage is not possible.

Optimizing the level of amputation is crucial, as preserving joint function and increasing limb length can enhance biomechanics, reduce energy consumption, and improve overall outcomes for amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in lower extremity amputations and prosthetics for the combat injured patient. Fergason, J., Keeling, JJ., Bluman, EM.[2022]

Minor amputations aim to preserve as much of the foot and leg as possible to maintain a load-bearing extremity, which is crucial for mobility and function.

Longitudinal partial amputations of the forefoot and midfoot are particularly beneficial as they help maintain stability and balance while minimizing complications associated with reduced surface area and muscle imbalance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Minor amputations: a maxi task : Part 2: From transmetatarsal amputation to hindfoot amputation]. Matamoros, R., Riepe, G., Drees, P.[2022]

The use of xenon 133 clearance to determine the appropriate level for below-knee amputations resulted in a 100% success rate in predicting healing for the last 30 cases, highlighting its effectiveness in surgical planning.

Patients who received immediate postoperative prostheses had a 0% thirty-day mortality rate and a 100% rehabilitation success rate, demonstrating the benefits of early prosthetic fitting in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Below-knee amputation: a modern approach. Roon, AJ., Moore, WS., Goldstone, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28051969/

Effects of Adding Neuromuscular Electrical Stimulation to ... Results: In both groups, residual limb quadriceps muscle strength and pain severity improved from baseline to 12 weeks. The NMES plus TMARP group showed ...

2. academic.oup.com academic.oup.com/milmed/article-pdf/182/1-2/e1528/21740488/milmed-d-16-00037.pdf

Effects of Adding Neuromuscular Electrical Stimulation to ... Results: In both groups, residual limb quadriceps muscle strength and pain severity improved from baseline to 12 weeks. The. NMES plus TMARP group showed ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00942890

Strength, Pain and Function in Operation Iraqi Freedom ... Those in the NMES group will receive 12 weeks of electrical muscle stimulation 15 min/day, 5 days a week for 12 weeks. Both groups will receive the standard 12- ...

4. withpower.com withpower.com/trial/nmes-for-amputation-74a67

NMES for Amputation The study seeks to understand NMES's effects on muscle parameters and pain to develop evidence-based interventions for amputees.Twenty participants with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590109521000811

Neuromuscular Electrical Stimulation Improves Activities of ... Evidence suggests that NMES has the ability to strengthen muscles,, reduce spasticity, increase excitability of corticospinal neural pathways, and augment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11242632/

Safety and Feasibility of Neuromuscular Electrical Stimulation ... In a recent systematic review, NMES was shown to be safe and feasible, and has beneficial effects on muscle strength and function in patients after cardiac ...

7. aetna.com aetna.com/cpb/medical/data/600_699/0677.html

Functional Electrical Stimulation and Neuromuscular ... This Clinical Policy Bulletin addresses functional electrical stimulation and neuromuscular electrical stimulation.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0987705324000017

Neuromuscular electrical stimulation for the treatment of ... NMES therapy as an adjunct to standard care for 10 weeks significantly increased lower limb nerve conductivity in patients with DSPN and may be beneficial in ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06830876/detecting-change-in-muscle-parameters-pain-and-function-with-nmes-for-tta?state=PA&city=Cranberry

Detecting Change in Muscle Parameters, Pain, and ... This study investigates the efficacy of a home-based Neuromuscular Electrical Stimulation (NMES) intervention in improving muscle parameters, ...