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

Trial Summary

What is the purpose of this trial?

The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss. Maintaining a healthy, pain-free residual limb is a primary concern for prosthesis users. Amputees commonly experience muscle deficits leading to mobility issues, poor prosthetic fit, and chronic pain. Neuromuscular electrical stimulation (NMES) is a potential intervention that activates muscles with low-level electrical stimulation, improving strength, function, and reducing pain. The study seeks to understand NMES's effects on muscle parameters and pain to develop evidence-based interventions for amputees. Twenty participants with transtibial amputations will undergo an 8-week NMES training program. Ultrasound imaging will assess muscle thickness, cross-sectional area, and composition changes. The study aims to enhance mobility, prosthetic fit, and overall well-being of amputees, addressing challenges and reducing healthcare burdens.

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.

How does NMES treatment for amputation differ from other treatments?

NMES (Neuromuscular Electrical Stimulation) is unique because it uses electrical impulses to stimulate muscle contractions, which can help maintain muscle function and prevent atrophy (muscle wasting) in amputees. This approach is different from traditional treatments that focus on surgical techniques and prosthetic fittings, as it directly targets muscle health and function. ^{1 2 3 4 5}

Research Team

Kyle Leister, PhD

Principal Investigator

East Tennessee Sate University

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preservation of the functional above knee stump following hip disarticulation by means of an Austin-Moore prosthesis. [2005]

2. United States pubmed.ncbi.nlm.nih.gov

Recent advances in lower extremity amputations and prosthetics for the combat injured patient. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Minor amputations: a maxi task : Part 2: From transmetatarsal amputation to hindfoot amputation]. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Does closed incision negative wound pressure therapy in non-traumatic major lower-extremity amputations improve survival rates? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Below-knee amputation: a modern approach. [2022]